菲律賓醫療器材登記法規問題集
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HLF-ph-10
請問菲律賓對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of medical devices in Philippines? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
菲律賓醫療器材主管機關為食品藥物管理局(FDA)，轄下的醫療器材管理與放射衛生研究中心(CDRRHR)，負責管理境內醫療器材與設備的生產、進出口、分銷、促銷、廣告、銷售等活動，以及法規制定、技術評估與許可產品的上市後監督。
醫療器材是指製造為單獨或組合用於人類的任何儀器、裝置、器具、機器、器具、植入物、體外試劑或校準器、軟件、材料或其他類似或相關物品，用於以下一個或多個特定目的：
1.診斷、預防、監測、治療或緩解疾病。
2.損傷的診斷、監測、治療、減輕或補償。
3.解剖結構或生理過程的調查、替換、修改或支持。
4.支持或維持生命。
5.預防感染。
6.控制受孕。
7.醫療器材消毒。
8.通過對人體標本進行體外檢查，為醫療或診斷目的提供信息。
該裝置不能通過藥理學、免疫學或代謝手段在人體內或人體上實現其主要預期作用，但可以通過這些手段輔助其達到預期功能。
醫療器材按照與設計和製造相關的潛在風險等級分為以下四類：
1. A 級：低風險。
2. B 類：中低風險。
3. C級：中高風險。
4. D 級：高風險。
In Philippine, medical device authority is the Food and Drug Administration (FDA), and the Medical Device Management and Radiological Health Research Center (CDRRHR) under its jurisdiction is responsible for managing the production, import, export, and distribution of domestic medical devices and equipment , promotion, advertising, sales, etc., as well as regulatory development, technical evaluation and post-market surveillance of licensed products.
Medical device means any instrument, device, appliance, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, manufactured for use in humans, alone or in combination, for use in one or more of the following a specific purpose:
1. Diagnose, prevent, monitor, treat, or alleviate disease.
2. Diagnosis, monitoring, treatment, mitigation or compensation of injury.
3. Investigation, replacement, modification or support of anatomical structures or physiological processes.
4. Supports or sustains life.
5. Prevent infection.
6. Control conception.
7. Disinfection of medical equipment.
8. To provide information for medical or diagnostic purposes by in vitro examination of human specimens.
The device cannot achieve its primary intended effect in or on the human body by pharmacological, immunological or metabolic means, but can be assisted in achieving its intended function by these means.
Medical devices are divided into the following four categories based on the level of potential risk associated with their design and manufacture:
1. Class A: Low risk.
2. Class B: Moderate to low risk.
3. Class C: Moderate to high risk.
4. Class D: High risk.
【參考連結】
HLF-ph-20
外國公司要到菲律賓銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell medical devices in Philippines, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests?
What are the required documents and application procedures? Website?
Evershine RD：
需要。在菲律賓從事醫療器材銷售或零售的企業需要從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
經營許可證(LTO)
1.申請人：菲律賓當地企業。
2.申請網頁：FDA e-portal https://eportal.fda.gov.ph
3.註冊資料
．電子郵件
．授權公司名稱、代表姓名、職位、聯繫電話
．授權書掃描檔(pdf)
4. LTO申請文件
．經銷商的公證申請表與聯合承諾書
．承諾書的電子副本
．營業許可證(商業名稱註冊證明)
．進口或配銷之醫療器材產品清單
．醫療器材銷售證明影本
．辦公室或倉儲位置圖與平面圖
．申請人或國內授權代表之照片
．國外製造商之GMP證書以及相關ISO認證之文件與證明，且須經菲律賓領事合法公證
．國外製造商與菲律賓當地經銷商的代理協議
．風險管理計劃
．費用支付
5.申請文件
．公司名稱、郵寄地址
．電話號碼
．傳真號碼
．電子郵件
．在現場製造和/或重新包裝的實際產品類型，提及它們的加工方式
．網站的簡短描述
．位置規劃和周邊環境
．平面圖和建築類型
．從事質量保證、質量控制、生產、儲存和配送、技術和工程支持服務的員工人數
．在製造和分析以及重新包裝方面使用外部科學、分析或其他技術援助
．顯示質量保證安排的組織結構圖，包括生產和質量控制
．關鍵人員的資格、經驗和職責
．基本和在職培訓的安排大綱以及記錄的保存方式
．從事生產人員的健康要求
．人員衛生要求，包括衣物和更衣區
．場地和設備
．具有規模的製造區域的計劃或描述
．結構和飾面的性質
．通風系統的簡要說明。對於具有潛在空氣污染風險的關鍵區域，應提供更多詳細信息。應該提到用於製造無菌產品的房間的分類。
．處理劇毒、危險和敏感材料的特殊區域
．計劃的預防性、糾正性和預測性維護計劃和記錄系統
．主要生產及受控實驗室設備簡述
．資格和校準，包括記錄系統
．清潔製造區域和設備的書面程序
．使用流程圖和圖表簡要描述生產操作
．起始材料、包裝材料、散裝和成品的安排，包括取樣、檢疫、放行和儲存
．再加工或返工安排
．處理拒收材料和產品的安排
．工藝驗證一般政策的簡要說明
．簡述品管體系及品管部成品放行程序
．描述質量控制系統的要素，例如：規格、測試方法和其他與質量相關的集合
．簡要描述分析測試、包裝和組件測試的活動
．概述文件的準備、修訂和分發的安排
．描述用於驗證活動是否符合既定標準以確保製造過程質量的自檢系統
．驗證質量體系的有效性
．確保存在自檢系統和後續行動的書面程序
．確保與被檢查區域的負責人討論自我檢查系統的結果並驗證活動的文件
．文件將確保該地區或活動的負責人對注意到的缺陷採取及時的糾正措施
．編制、修訂和分發文件的安排
．文件系統描述
．負責文件的準備、修訂和分發
．主文件的存儲
．文件準備程序
．文件控制
．與產品質量有關
．設備規格
．標準作業程序
．質量控製程序
．培訓程序
．過程偏差的文檔控制
．校準和測試文件
．驗證文件
．原材料批次、主要包裝組件的核對
．分銷、投訴和產品召回
6. 許可後檢查
在營業時間內接受 FDA 授權人員的例行或抽查檢查。檢查時應核對下列文件：
．商業名稱註冊證明
．營業執照（如果企業地址與企業名稱註冊地址不同）
．合格人員的證書
．由學術界或工業界提供的關於醫療器材安全、質量和使用的研討會、培訓、學習和發展活動的出席證書
．標準操作程序，包括監測醫療器材產品的質量並反映遵守良好儲存和分銷規範
．FDA簽發的有效LTO
．銷售的醫療器材的 CMDN/CMDR（如適用）副本
．風險管理計劃等
7.備註
．企業應至少擁有一名合格人員(QP)，須為全職員工，有責任遵守 FDA 的技術要求，或在提交技術要求時與 FDA 討論或澄清事項，或在進行檢查或上市後監督 (PMS) 活動時與 FDA 官員接觸。合格人員可以是企業的正式授權人員。
．業者須有實體據點，無實體據點之業者申請必定會遭駁回或撤銷。
Yes. Businesses engaged in the sale or retail of medical devices in the Philippines need to obtain a license to operate (LTO) and complete product registration from the Philippine Food and Drug Administration (FDA).
License to operate (LTO)
1. Applicant: a local company in the Philippines.
2. Application webpage: FDA e-portal https://eportal.fda.gov.ph
3. Registration Information
．Authorized company name, representative name, title, contact number
．Scanned file of authorization letter (pdf)
4. LTO application documents
．Distributor’s Notary Application Form and Joint Commitment
．Electronic copy of the undertaking
．Business license (business name registration certificate)
．List of medical devices imported or distributed
．Copy of medical equipment sales certificate
．Office or warehouse location plans and floor plans
．Photograph of applicant or authorized representative in China
．The GMP certificate of the foreign manufacturer and the relevant ISO certification documents and certificates, which must be notarized by the Philippine consulate.
．Agency Agreement for Foreign Manufacturers and Local Distributors in the Philippines
．Risk management plan
．Pay
5. Application documents
．Company name, mailing address
．Telephone number
．Fax number
．Actual product types manufactured and/or repackaged on site, mentioning how they were processed
．A short description of the site
．Location Planning and Surroundings
．Floor plans and building types
．Number of employees engaged in quality assurance, quality control, production, storage and distribution, technical and engineering support services
．Use of outside scientific, analytical or other technical assistance in manufacturing and analysis and repackaging
．Organizational chart showing quality assurance arrangements, including production and quality control
．Qualifications, experience and responsibilities of key personnel
．Outline of basic and on-the-job training arrangements and record keeping
．Health requirements for workers engaged in production
．Personnel hygiene requirements, including clothing and changing areas
．Venue and Equipment
．Plan or description of a manufacturing area with scale
．The nature of structures and finishes
．Brief description of the ventilation system. More details should be provided for critical areas with potential air pollution risks. The classification of rooms used for the manufacture of sterile products should be mentioned.
．Special areas for handling highly toxic, hazardous and sensitive materials
．Planned preventive, corrective and predictive maintenance planning and recording system
．Brief description of main production and controlled laboratory equipment
．Qualification and calibration, including recording systems
．Written procedures for cleaning manufacturing areas and equipment
．Briefly describe production operations using flowcharts and diagrams
．Arrangements for starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage
．Rework or Rework Arrangements
．Arrangements for Handling Rejected Materials and Products
．Brief Description of General Policy on Process Validation
．Briefly describe the quality control system and the finished product release procedures of the quality control department
．Describe the elements of a quality control system, such as: specifications, test methods, and other quality-related collections
．Briefly describe the activities of analytical testing, packaging and component testing
．Outline the arrangements for the preparation, revision and distribution of documents
．Describe the self-inspection system used to verify that activities conform to established standards to ensure the quality of the manufacturing process
．Verify the effectiveness of the quality system
．Written procedures to ensure that a self-check system and follow-up are in place
．Ensure that the results of the self-inspection system are discussed with the person in charge of the inspected area and the documentation of the verification activities
．Documentation will ensure that the head of the area or activity takes prompt corrective action for deficiencies noted
．Arrangements for the preparation, revision and distribution of documents
．Filesystem description
．Responsible for document preparation, revision and distribution
．Storage of main files
．Document preparation procedure
．Document Control
．Related to product quality
．Equipment Specifications
．Standard operating procedures
．Quality Control Procedure
．Training program
．Documentation Control of Process Deviations
．Calibration and test files
．Verify documents
．Reconciliation of batches of raw materials, major packaging components
．Distribution, Complaints and Product Recalls
6. Post-licensing checks
Receive routine or spot checks by FDA-authorized personnel during business hours. The following documents should be checked during inspection:
．Business name registration certificate
．Business license (if the business address is different from the business name registered address)
．Qualified Person’s Certificate
．Certificate of attendance at seminars, training, learning and development events provided by academia or industry on the safety, quality and use of medical devices
．Standard operating procedures, including monitoring the quality of medical device products and reflecting compliance with good storage and distribution practices
．Valid LTO issued by FDA
．A copy of the CMDN/CMDR (if applicable) of the medical device sold
．Risk management plan, etc.
7. Remarks
．The establishment should have at least one Qualified Person (QP), who must be a full-time employee who is responsible for complying with FDA technical requirements or discussing or clarifying matters with FDA when submitting technical requirements, or conducting inspections or post-market surveillance (PMS) activities contact FDA officials. Qualified persons may be duly authorized persons of the business.
．The business operator must have a physical base, and the application of a business operator without a physical base will be rejected or withdrawn.
【參考連結】
HLF-ph-25
HLF-ph-30
外國公司要到菲律賓銷售醫療器材，可以指派菲律賓公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？
所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell medical devices in Philippines, can it assign an Philippines company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。在菲律賓從事醫療器材銷售或零售的企業需要以當地企業名義從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊，外國公司可以設立法人子公司或指定當地經銷商，或者委任獨立第三方。
經營許可證(LTO)
1.申請人：菲律賓當地企業。
2.申請網頁：FDA e-portal https://eportal.fda.gov.ph
3.註冊資料
．電子郵件
．授權公司名稱、代表姓名、職位、聯繫電話
．授權書掃描檔(pdf)
4. LTO申請文件
．經銷商的公證申請表與聯合承諾書
．承諾書的電子副本
．營業許可證(商業名稱註冊證明)
．進口或配銷之醫療器材產品清單
．醫療器材銷售證明影本
．辦公室或倉儲位置圖與平面圖
．申請人或國內授權代表之照片
．國外製造商之GMP證書以及相關ISO認證之文件與證明，且須經菲律賓領事合法公證
．國外製造商與菲律賓當地經銷商的代理協議
．風險管理計劃
．費用支付
5.申請文件
．公司名稱、郵寄地址
．電話號碼
．傳真號碼
．電子郵件
．在現場製造和/或重新包裝的實際產品類型，提及它們的加工方式
．網站的簡短描述
．位置規劃和周邊環境
．平面圖和建築類型
．從事質量保證、質量控制、生產、儲存和配送、技術和工程支持服務的員工人數
．在製造和分析以及重新包裝方面使用外部科學、分析或其他技術援助
．顯示質量保證安排的組織結構圖，包括生產和質量控制
．關鍵人員的資格、經驗和職責
．基本和在職培訓的安排大綱以及記錄的保存方式
．從事生產人員的健康要求
．人員衛生要求，包括衣物和更衣區
．場地和設備
．具有規模的製造區域的計劃或描述
．結構和飾面的性質
．通風系統的簡要說明。對於具有潛在空氣污染風險的關鍵區域，應提供更多詳細信息。應該提到用於製造無菌產品的房間的分類。
．處理劇毒、危險和敏感材料的特殊區域
．計劃的預防性、糾正性和預測性維護計劃和記錄系統
．主要生產及受控實驗室設備簡述
．資格和校準，包括記錄系統
．清潔製造區域和設備的書面程序
．使用流程圖和圖表簡要描述生產操作
．起始材料、包裝材料、散裝和成品的安排，包括取樣、檢疫、放行和儲存
．再加工或返工安排
．處理拒收材料和產品的安排
．工藝驗證一般政策的簡要說明
．簡述品管體系及品管部成品放行程序
．描述質量控制系統的要素，例如：規格、測試方法和其他與質量相關的集合
．簡要描述分析測試、包裝和組件測試的活動
．概述文件的準備、修訂和分發的安排
．描述用於驗證活動是否符合既定標準以確保製造過程質量的自檢系統
．驗證質量體系的有效性
．確保存在自檢系統和後續行動的書面程序
．確保與被檢查區域的負責人討論自我檢查系統的結果並驗證活動的文件
．文件將確保該地區或活動的負責人對注意到的缺陷採取及時的糾正措施
．編制、修訂和分發文件的安排
．文件系統描述
．負責文件的準備、修訂和分發
．主文件的存儲
．文件準備程序
．文件控制
．與產品質量有關
．設備規格
．標準作業程序
．質量控製程序
．培訓程序
．過程偏差的文檔控制
．校準和測試文件
．驗證文件
．原材料批次、主要包裝組件的核對
．分銷、投訴和產品召回
6. 許可後檢查
在營業時間內接受 FDA 授權人員的例行或抽查檢查。檢查時應核對下列文件：
．商業名稱註冊證明
．營業執照（如果企業地址與企業名稱註冊地址不同）
．合格人員的證書
．由學術界或工業界提供的關於醫療器材安全、質量和使用的研討會、培訓、學習和發展活動的出席證書
．標準操作程序，包括監測醫療器材產品的質量並反映遵守良好儲存和分銷規範
．FDA簽發的有效LTO
．銷售的醫療器材的 CMDN/CMDR（如適用）副本
．風險管理計劃等
7.備註
．企業應至少擁有一名合格人員(QP)，須為全職員工，有責任遵守 FDA 的技術要求，或在提交技術要求時與 FDA 討論或澄清事項，或在進行檢查或上市後監督 (PMS) 活動時與 FDA 官員接觸。合格人員可以是企業的正式授權人員。
．業者須有實體據點，無實體據點之業者申請必定會遭駁回或撤銷。
責任
1.醫療器材企業、製造商、分銷商、進口商、出口商、批發商都必須具備質量管理體系 (QMS) 和相關文件。菲律賓 FDA 在其例行檢查期間對其進行檢查和審核。QMS 必須包括既定的風險管理計劃 (RMP) 和標準操作程序 (SOP) 及其相關表格，用於良好的存儲和分發、投訴處理、產品召回、醫療器材處置/銷毀。
2.報告不良事件的醫療器材公司將需要通過電子郵件將其 AE 報告發送給器材監管輻射健康與研究中心 (CDRRHR) 主任和產品研究與標準制定部 (PRSDD) 處長。FDA 評估員接受所有經銷商、製造商、所有者、設備最終用戶使用規定格式的報告。
3.評估員將針對不良事件/投訴向賣方、製造商或所有者發出糾正和預防措施 ( CAPA ) 並實施糾正措施。要求提交報告。根據結果，可能會建議/監控或召回醫療設備。
4.發生在菲律賓境外的不良事件不需要向 PFDA 報告，除非用戶是菲律賓人並且設備是從菲律賓獲得的（或除非另有要求），並且僅說明事件發生的國家。
5.合格人員的責任
機構的合格人員應負責確保醫療器材的安全性、質量和有效性/性能，包括以下內容：
．遵守良好的儲存和分配做法以及其他相關和適用的做法。
．監控產品庫存，包括有效期（如適用）。
．確保患者/消費者經歷的任何不良事件都得到妥善處理、記錄並報告給企業的供應商/分銷商。導致或促成消費者、患者或任何人死亡、嚴重疾病或嚴重傷害的事件應通過設備監管、輻射健康和研究中心向食品和藥物管理局報告。
．確保所有出售的醫療器材產品均獲得 FDA 頒發的相應授權。
．確保企業遵守現有的 FDA 醫療器材法規和建議。
．在購買和銷售醫療器材之前，需要獲得機構供應商/分銷商的適當授權。
Yes. Companies engaged in the sales or retail of medical equipment in the Philippines need to obtain a license to operate (LTO) and complete product registration from the Philippine Food and Drug Administration (FDA) in the name of a local company. Foreign companies can set up legal entities or designate local distributors, or Appoint an independent third party.
License to operate (LTO)
1. Applicant: a local company in the Philippines.
2. Application webpage: FDA e-portal https://eportal.fda.gov.ph
3. Registration Information
．Authorized company name, representative name, title, contact number
．Scanned file of authorization letter (pdf)
4. LTO application documents
．Distributor’s Notary Application Form and Joint Commitment
．Electronic copy of the undertaking
．Business license (business name registration certificate)
．List of medical devices imported or distributed
．Copy of medical equipment sales certificate
．Office or warehouse location plans and floor plans
．Photograph of applicant or authorized representative in China
．The GMP certificate of the foreign manufacturer and the relevant ISO certification documents and certificates, which must be notarized by the Philippine consulate.
．Agency Agreement for Foreign Manufacturers and Local Distributors in the Philippines
．Risk management plan
．Pay
5. Application documents
．Company name, mailing address
．Telephone number
．Fax number
．Actual product types manufactured and/or repackaged on site, mentioning how they were processed
．A short description of the site
．Location Planning and Surroundings
．Floor plans and building types
．Number of employees engaged in quality assurance, quality control, production, storage and distribution, technical and engineering support services
．Use of outside scientific, analytical or other technical assistance in manufacturing and analysis and repackaging
．Organizational chart showing quality assurance arrangements, including production and quality control
．Qualifications, experience and responsibilities of key personnel
．Outline of basic and on-the-job training arrangements and record keeping
．Health requirements for workers engaged in production
．Personnel hygiene requirements, including clothing and changing areas
．Venue and Equipment
．Plan or description of a manufacturing area with scale
．The nature of structures and finishes
．Brief description of the ventilation system. More details should be provided for critical areas with potential air pollution risks. The classification of rooms used for the manufacture of sterile products should be mentioned.
．Special areas for handling highly toxic, hazardous and sensitive materials
．Planned preventive, corrective and predictive maintenance planning and recording system
．Brief description of main production and controlled laboratory equipment
．Qualification and calibration, including recording systems
．Written procedures for cleaning manufacturing areas and equipment
．Briefly describe production operations using flowcharts and diagrams
．Arrangements for starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage
．Rework or Rework Arrangements
．Arrangements for Handling Rejected Materials and Products
．Brief Description of General Policy on Process Validation
．Briefly describe the quality control system and the finished product release procedures of the quality control department
．Describe the elements of a quality control system, such as: specifications, test methods, and other quality-related collections
．Briefly describe the activities of analytical testing, packaging and component testing
．Outline the arrangements for the preparation, revision and distribution of documents
．Describe the self-inspection system used to verify that activities conform to established standards to ensure the quality of the manufacturing process
．Verify the effectiveness of the quality system
．Written procedures to ensure that a self-check system and follow-up are in place
．Ensure that the results of the self-inspection system are discussed with the person in charge of the inspected area and the documentation of the verification activities
．Documentation will ensure that the head of the area or activity takes prompt corrective action for deficiencies noted
．Arrangements for the preparation, revision and distribution of documents
．Filesystem description
．Responsible for document preparation, revision and distribution
．Storage of main files
．Document preparation procedure
．Document Control
．Related to product quality
．Equipment Specifications
．Standard operating procedures
．Quality Control Procedure
．Training program
．Documentation Control of Process Deviations
．Calibration and test files
．Verify documents
．Reconciliation of batches of raw materials, major packaging components
．Distribution, Complaints and Product Recalls
6. Post-licensing checks
Receive routine or spot checks by FDA-authorized personnel during business hours. The following documents should be checked during inspection:
．Business name registration certificate
．Business license (if the business address is different from the business name registered address)
．Qualified Person’s Certificate
．Certificate of attendance at seminars, training, learning and development events provided by academia or industry on the safety, quality and use of medical devices
．Standard operating procedures, including monitoring the quality of medical device products and reflecting compliance with good storage and distribution practices
．Valid LTO issued by FDA
．A copy of the CMDN/CMDR (if applicable) of the medical device sold
．Risk management plan, etc.
7. Remarks
．The establishment should have at least one Qualified Person (QP), who must be a full-time employee who is responsible for complying with FDA technical requirements or discussing or clarifying matters with FDA when submitting technical requirements, or conducting inspections or post-market surveillance (PMS) activities contact FDA officials. Qualified persons may be duly authorized persons of the business.
．The business operator must have a physical base, and the application of a business operator without a physical base will be rejected or withdrawn.
Responsibility
1. Medical device companies, manufacturers, distributors, importers, exporters, wholesalers are required to have a Quality Management System (QMS) and related documents. The Philippines FDA inspects and audits it during its routine inspections. The QMS must include an established Risk Management Plan (RMP) and Standard Operating Procedure (SOP) and its associated forms for good storage and distribution, complaint handling, product recall, medical device disposal/destruction.
2. Medical device companies reporting adverse events will be required to email their AE reports to the Director of the Center for Device Regulatory Radiation Health and Research (CDRRHR) and the Director of the Product Research and Standards Development Department (PRSDD). FDA assessors accept reports in the prescribed format from all distributors, manufacturers, owners, equipment end users.
3. The assessor will issue a Corrective and Preventive Action (CAPA) to the seller, manufacturer or owner for the adverse event/complaint and implement corrective action. Request to submit a report. Depending on the results, medical devices may be recommended/monitored or recalled.
4. Adverse events that occur outside the Philippines do not need to be reported to PFDA unless the user is Filipino and the device was obtained from the Philippines (or unless otherwise requested), and only the country in which the event occurred is stated.
5. Responsibilities of Qualified Persons
Qualified personnel at the facility shall be responsible for ensuring the safety, quality, and efficacy/performance of medical devices, including the following:
．Follow good storage and distribution practices and other relevant and applicable practices.
．Monitor product inventory, including expiration dates (if applicable).
．Ensure that any adverse events experienced by the patient/consumer are properly handled, recorded and reported to the business’s supplier/distributor. Events that cause or contribute to the death, serious illness or serious injury of consumers, patients or anyone should be reported to the Food and Drug Administration through the Center for Device Regulation, Radiation Health and Research.
．Ensure that all medical device products sold are appropriately authorized by the FDA.
．Ensure that businesses comply with existing FDA medical device regulations and recommendations.
．Appropriate authorization from institutional suppliers/distributors is required before purchasing and selling medical equipment.
【參考連結】
https://www.fda.gov.ph/wp-content/uploads/2022/05/LRD2_Annex-1_Site-Master-File.pdf
HLF-ph-35
HLF-ph-40
外國公司銷售到菲律賓醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
Do foreign companies need to apply for an approval before importing medical devices sold to Philippines? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
進口醫療器材需由製造商授權菲律賓當地企業依照醫療器材的分類，向FDA提出通知或完成產品註冊。
A 類醫療器材需完成通知，取得醫療設備通知證書 (CMDN)。B、C、D類器材需註冊，取得醫療器材註冊證書(CMDR)。
A 類醫療器材通知(CMDN)
1.申請人：製造商授權菲律賓當地企業(需具備經營許可證)。
2.申請網頁：FDA e-portal線上提交
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3.申請流程：
．申請者需具備有效LTO，以註冊CPR。
．獲得e-portal帳號及密碼。
．提交產品原料等相關資料。
．文件評估，如果所有文件都準確無誤，FDA 將頒發 CMDN。
4.法律要求
．公證申請表。
．付款。
．授權書副本，進口醫療器材授權書副本應附有合法生產商或產品所有人出具的授權真實無誤的公證聲明原件。
．政府頒發證明製造商在人員和設施的能力和可靠性方面的地位的證書、質量體系批准證書或 ISO 13485 合規證書。對於進口醫療器材，副本證書應附有合法製造商或產品所有者出具的證明證書真實無誤的公證聲明原件。
．原產國監管機構或認可的公告機構出具的產品通知證書、產品註冊證書或證明該器材安全性和有效性的任何等效文件。證書副本應附有合法製造商或產品所有人出具的證明該證書真實無誤的公證聲明原件。
．設備各方面的彩色圖片，可能需要有代表性的樣品或商業演示來進行驗證。
．醫療器材產品免費銷售證明。
5.申請表內容
．設備名稱。
．設備專有/品牌名稱。
．型號/參考編號/屬性代碼/項目代碼。
．設備的預期用途。
．申請人公司名稱、地址。
．LTO 編號有效期。
．電話號碼、傳真、電子郵件地址。
．公司負責人/總經理。
．監管人。
．合法製造商(產品持有人) 、地址。
．生產現場。
．簽署聲明。
6. 技術要求
．設備描述：預期用途、使用說明。
．所有原材料清單。
．成品技術規格。
．參考代碼、尺寸、顏色、型號和差異的列表(以適用者為準) 。
．政府機構頒發與計量相關製造方面的合格證書(如適用) 。
．符合產品標準的符合性聲明/製造商的自我聲明(如適用) 。
．清晰完整標籤彩色圖片。
．保質期聲明。
7.備註
．文件和標籤應以英文提供。
．CMDN認證有效期為 5 年，必須在初始批准後每五年更新一次，可以在到期前90天提交展延。
B、C、D類醫療器材註冊(CMDR)
1.申請人：製造商授權菲律賓當地企業(需具備經營許可證)。
2.申請網頁：以 CSDT 格式通過電子郵件提交檔案，FDA將審查申請。
3.申請流程：
．申請者需具備有效LTO，以註冊CPR。
．獲得e-portal帳號及密碼。
．提交產品原料等相關資料。
．文件評估，如果所有文件都準確無誤，FDA 將頒發 CMDN。
4.法律要求
．公證申請表
．付款
．授權書副本，進口醫療器材授權書副本應附有合法生產商或產品所有人出具的授權真實無誤的公證聲明原件。
．政府頒發證明製造商在人員和設施的能力和可靠性方面的地位的證書、質量體系批准證書或 ISO 13485 合規證書。對於進口醫療器材，副本證書應附有合法製造商或產品所有者出具的證明證書真實無誤的公證聲明原件。
．原產國監管機構或認可的公告機構出具的產品通知證書、產品註冊證書或證明該器材安全性和有效性的任何等效文件。證書副本應附有合法製造商或產品所有人出具的證明該證書真實無誤的公證聲明原件。
．設備各方面的彩色圖片，可能需要有代表性的樣品或商業演示來進行驗證。
．醫療器材產品免費銷售證明。
5.申請表內容
．設備名稱
．設備專有/品牌名稱
．型號/參考編號/屬性代碼/項目代碼
．分類：B類/C類/D類
．設備的預期用途
．申請人公司名稱、地址
．LTO 編號有效期
．電話號碼、傳真、電子郵件
．公司負責人/總經理
．監管人
．合法製造商(產品持有人) 、地址
．生產現場
．簽署聲明
6.技術要求
．執行摘要：概述、商業營銷史、標籤中的預期用途和指示、獲得的監管批准或營銷許可清單、任何未決的市場清關請求的狀態、重要的安全/性能相關信息。
．用於證明符合性的相關基本原則和方法(如果適用)。
．設備描述：預期用途、使用適應症、使用說明、禁忌症、警告、預防措施、潛在的不利影響、替代療法(實踐和程序)。
．材料：包括設備材料的完整化學、生物和物理特性。
．設備的功能特性和技術性能規格，包括相關的：測量和診斷醫療設備的準確性、靈敏度、特異性、可靠性和其他因素
．包括化學、物理、電氣、機械、生物、軟件、無菌、穩定性、儲存和運輸以及包裝(如果適用)。
．符合相關基本原則的其他描述性信息(例如：成品醫療器材的生物相容性類別)(如果適用)。
．符合製造商發布的產品標準的聲明/證書。
．基於其他標準、製造商方法和測試或證明合規性的替代方法的測試和評估的摘要或報告，例如從已發表的報告中列出的、涉及醫療器材方面的安全和性能的報告和參考的結論基本原則。
．涵蓋以下適當測試報告的數據摘要或測試報告和評估，以適用者為準：工程試驗、實驗室測試、生物相容性試驗、動物試驗、模擬使用、軟件驗證、臨床前研究。
．清晰完整包裝各個角度的標籤彩色圖片(散裝標籤或各層包裝的樣品)
．包含結果的風險分析。
．物理製造商信息製造過程，包括質量保證措施。這應包括製造方法和程序、製造環境或條件、設施和控制。該信息可以以工藝流程圖的形式呈現，該流程圖顯示了成品醫療器材的生產、控制、組裝、最終產品測試和包裝的概述。
．應包括對滅菌方法的簡要總結。
7.備註
．B等級產品僅須提供臨床前研究，風險評估僅須提供風險分析及其結果。
．C等級產品如屬於植入式器材、新進器材、含有新物質且與病患直接接觸之器材等，須提供臨床試驗證據。需檢附生物性評估報告。風險評估要求包含完整的風險分析、風險評估及減少風險措施。
．D等級產品均須提供臨床試驗證據。檢附過去有關產品使用、安全、效能之公開報告的參考目錄。風險評估要求包含完整的風險分析、風險評估及減少風險措施。
．文件和標籤應以英文提供。
． CMDR 認證有效期為 5 年，必須在初始批准後每五年更新一次，可以在到期前90天提交展延。
標籤
1.應根據特定的醫療器材及預期用途，按以下形式放置在適當位置：
．在適當的情況下，應在醫療器材本身上提供識別、安全使用醫療器材所需的信息。如果這不可行或不合適，部分或全部信息可能會出現在每個單元的包裝(初級包裝)和/或包裝在一起的多個醫療器材的外包裝上(二級包裝)。
．如果每個單元的單獨包裝不可行或不合適，則應在使用說明 (IFU) 中列出信息(例如傳單、包裝插頁、手冊或其他提供的介質。)
．如果產品所有者向單個用戶和/或位置提供多個醫療設備，則僅向他們提供一份使用說明的副本可能就足夠且適當。在這些情況下，醫療器材用戶應有權取得更多副本。
2. 標籤的媒介、格式、內容、可讀性和位置應適合特定的醫療器材、預期用途以及預期用戶的技術知識、經驗、教育或培訓。特別是，使用說明應以預期用戶易於理解的語言編寫，並在適當時輔以圖紙和圖表。一些醫療設備可能需要為醫療保健專業人員和非專業人士提供單獨的信息。
3. 如果在沒有任何此類說明的情況下可以按照產品所有者的意圖安全使用，則可能不需要使用說明 (IFU)，或者可以將其用於低風險或中等風險的醫療設備。
4. 所有標籤的紙質版本/硬拷貝應隨附醫療器材。
5. 風險分析中識別出的任何殘餘風險應在標籤中體現為禁忌症、注意事項或警告。
6. 鼓勵使用國際公認的符號，前提是醫療器材安全不會因患者或用戶缺乏理解而受到影響。符號的含義對醫療器材用戶來說並不明顯，例如：對於非專業用戶或新引入的符號，應提供解釋。
7. 標籤上的所有字符都應具有足夠的尺寸和清晰的印刷。
8. 產品標籤應以英文和/或菲律賓文書寫。
9. 標籤與包裝背景的顏色對比，設計不得掩蓋信息。
10. 對於醫療器材軟件，用戶說明應以電子數據存儲設備(如光盤、數字視頻光盤或 USB 閃存驅動器/或其他媒體)形式提供。
11. 對於可從互聯網下載的信息，互聯網網址應清楚地印在設備的物理標籤上，並以向用戶突出其目的的方式顯示。產品所有者應確保電子標籤的內容與隨產品註冊申請提交的紙質格式(如適用)一致。用戶和/或其他相關方也可以根據要求訪問 IFU 的紙質版本。
12. 標籤不得包含任何直接或間接表明該醫療器材在市場上的投放、醫療器材的使用或操作正在由衛生部 – 食品和藥物管理局推廣或認可的任何聲明(或其任何組織機構)。
13.醫療器材包裝上應標註的下列具體內容：
．產品名稱、商品名稱或品牌名稱，以允許用戶識別醫療器材。
．產品所有者的姓名、地址和聯繫方式(例如電話號碼和獲取技術幫助的網址)。
．FDA-CDRRHR在各級包裝上頒發的醫療器材通知號證明或醫療器材註冊證號。
．進口商和/或分銷商的名稱和地址。除非無菌性和自身壽命受到影響，否則所有級別的包裝都是強制性的。
．用戶識別醫療器材的足夠詳細信息。
．批號、批號或序列號(如適用)。
．到期日期至少以年和月表示(例如 2020 年 11 月)。
．特殊儲存/容器、處理條件和/或儲存條件。
．製造日期至少以年和月表示。
．驗證醫療器材是否正確安裝以及是否能夠正確和安全運行所需的信息，包括性質的詳細信息。預防性和定期維護的頻率，任何質量控制、消耗性組件的更換和校準所需的校準確保醫療設備在其預期壽命內正常安全運行(如果適用)
．產品所有者預期的性能，以及相關的任何不良副作用。
．醫療器材可以使用之前所需的任何進一步處理或處理的詳細信息(例如，滅菌、最終組裝、校準、試劑和/或控製材料的製備等)。
．無菌醫療器材的標示和滅菌方法(例如：無菌加工技術滅菌；使用環氧乙烷滅菌；使用輻照滅菌和/或使用蒸汽或乾熱滅菌)；有關如果無菌包裝損壞該怎麼辦的信息；以及重新滅菌的說明(如果適用)。
．產品所有者指定的一次性醫療器材標示。
．可重複使用的醫療器材的標示，允許重複使用的適當過程的信息，包括清潔、消毒、包裝，以及適當的再消毒方法和重複使用次數的任何限制。
．醫療器材使用前的滅菌要求和清洗、滅菌工藝說明。
．應當註明翻新醫療器材的標示和翻新日期。
．定制醫療器材的標示和由合格從業者使用的聲明。
．如果醫療器材旨在用於臨床調查，或者對於 IVD 醫療器材，則需表明僅用於性能評估。
．如果醫療器材旨在僅用於研究和僅用於展示或演示目的，則應標註：不得用於人體。
．如果醫療器材僅供研究使用，則必須標明僅供研究使用。
．與植入可植入醫療器材有關的特殊風險。
．如果醫療器材為醫療目的發射輻射，應在其性質、類型和適當情況下詳細說明該輻射的強度和分佈。輻射源將產生的醫療器材特定部分(例如 X 射線管)上的輻射符號也應標明。
．有關在特定調查、評估、治療或使用過程中合理可預見的醫療設備存在所造成的相互干擾風險的信息(例如來自其他設備的電磁干擾)。
．如果醫療器材要與其他醫療器材或設備或專用軟件一起安裝或連接，以便按其預期用途的要求運行，其特徵的足夠詳細信息以識別正確的醫療器材或設備使用以獲得安全的組合。
．體外診斷醫療器材應標註體外診斷。
Imported medical devices need to be authorized by the manufacturer to notify the FDA or complete the product registration according to the classification of the medical device. Class A medical devices are required to complete notification and obtain a Certificate of Medical Device Notification (CMDN). Class B, C, and D devices need to be registered, and a medical device registration certificate (CMDR) must be obtained.
Class A Medical Device Notification (CMDN)
1. Applicant: The manufacturer authorizes a local company in the Philippines (requires an operating license).
2. Application webpage: FDA e-portal online submission
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3. Application process:
．Applicants are required to have a valid LTO to register for CPR.
．Obtain e-portal account and password.
．Submit product materials and other relevant information.
．Document evaluation, if all documents are accurate, FDA will issue a CMDN.
4. Legal requirement
．Notary application form.
．Payment.
．A copy of the authorization letter, and the copy of the authorization letter for imported medical equipment should be accompanied by the original notarized statement of authorization issued by the legitimate manufacturer or product owner.
．A government-issued certificate certifying the manufacturer’s standing with respect to the competence and reliability of people and facilities, a quality system approval certificate, or an ISO 13485 compliance certificate. For imported medical devices, the duplicate certificate should be accompanied by the original notarized statement from the legal manufacturer or product owner certifying that the certificate is true.
．Product notification certificate, product registration certificate, or any equivalent document certifying the safety and effectiveness of the device, issued by the country of origin regulatory body or a recognized notified body. A copy of the certificate should be accompanied by the original notarized statement from the legitimate manufacturer or product owner certifying that the certificate is true.
．Color pictures of various aspects of equipment, representative samples or commercial demonstrations may be required for verification.
．Certificate of free sale of medical equipment products.
5. Contents of the application form
．Device name.
．Device proprietary/brand name.
．Model/Reference Number/Property Code/Item Code.
．Intended use of the device.
．Applicant’s company name and address.
．LTO number validity period.
．Phone number, fax, email address.
．Company manager/general manager.
．Supervisor.
．Legal manufacturer (product owner), address.
．Production site.
．Sign the statement.
6. Technical requirements
．Device description: Intended use, instructions for use.
．List of all raw materials.
．Finished technical specifications.
．Refer to a list of codes, sizes, colors, models and differences (whichever applies).
．Government agencies issue certificates of conformity with respect to metrology-related manufacturing, if applicable.
．Declaration of Conformity/Manufacturer’s Self-Declaration (if applicable) to the product standard.
．Clear and complete labels with color pictures.
．Shelf life statement.
7. Note
．Documentation and labels should be provided in English.
．CMDN certification is valid for 5 years and must be renewed every five years after initial approval, and extensions can be submitted 90 days prior to expiration.
Class B, C, D Medical Device Registration (CMDR)
1. Applicant: The manufacturer authorizes a local company in the Philippines (a business license is required).
2. Application Webpage: Submit the dossier by email in CSDT format, and FDA will review the application.
3. Application process:
．Applicants are required to have a valid LTO to register for CPR.
．Obtain e-portal account and password.
．Submit product materials and other relevant information.
．Document evaluation, if all documents are accurate, FDA will issue a CMDN.
4. Legal requirement
．Notary application form
．Payment
．A copy of the authorization letter, the copy of the authorization letter for imported medical equipment should be accompanied by the original notarized statement of authorization issued by the legal manufacturer or product owner.
．Government-issued certificates certifying the manufacturer’s standing with respect to the competence and reliability of people and facilities, quality system approvals, or ISO 13485 compliance. For imported medical devices, the duplicate certificate should be accompanied by the original notarized statement from the legal manufacturer or product owner certifying the authenticity of the certificate.
．Product notification certificate, product registration certificate, or any equivalent document certifying the safety and efficacy of the device, issued by the country of origin regulatory body or recognized notified body. A copy of the certificate should be accompanied by the original notarized statement from the legitimate manufacturer or product owner certifying the authenticity of the certificate.
．Color pictures of various aspects of the device, a representative sample or commercial demonstration may be required for verification.
．Certificate of free sale of medical equipment products.
5. Contents of the application form
．Device name
．Device Proprietary/Brand Name
．Model / Reference Number / Property Code / Item Code
．Classification: Class B/Class C/Class D
．Intended use of the device
．Applicant company name and address
．LTO number validity period
．Phone number, fax, email
．Company person/general manager
．Supervisor
．Legal manufacturer (product owner), address
．Production site
．Sign the statement
6. Technical requirements
．Executive Summary: Overview, Commercial Marketing History, Intended Use and Indications on Labels, List of Regulatory Approvals or Marketing Authorizations Obtained, Status of Any Pending Market Clearance Requests, Important Safety/Performance Related Information.
．Relevant underlying principles and methods used to demonstrate compliance, if applicable.
．Device Description: Intended Use, Indications for Use, Instructions for Use, Contraindications, Warnings, Precautions, Potential Adverse Effects, Alternative Therapies (Practices and Procedures).
．Materials: Includes complete chemical, biological, and physical properties of device materials.
．Functional characteristics and technical performance specifications of devices, including related: accuracy, sensitivity, specificity, reliability and other factors for measuring and diagnosing medical devices
．Includes chemical, physical, electrical, mechanical, biological, software, sterility, stability, storage and shipping, and packaging (if applicable).
．Other descriptive information (e.g., biocompatibility class of finished medical device) consistent with relevant underlying principles, if applicable.
．Declaration/Certificate of compliance with the manufacturer’s published product standards.
．Summaries or reports of tests and evaluations based on other standards, manufacturer’s methods and tests or alternative methods of demonstrating compliance, such as those listed and referenced from published reports dealing with the safety and performance of medical devices Conclusion basic principles.
．Data summaries or test reports and evaluations covering the following appropriate test reports, whichever is applicable: engineering testing, laboratory testing, biocompatibility testing, animal testing, simulated use, software validation, preclinical studies.
．Color pictures of the labels from all angles of the clear and complete package (bulk labels or samples of each layer of packaging)
．Risk analysis with results.
．Physical manufacturer information on the manufacturing process, including quality assurance measures. This should include manufacturing methods and procedures, manufacturing environment or conditions, facilities and controls. This information can be presented in the form of a process flow diagram showing an overview of the production, control, assembly, final product testing and packaging of the finished medical device.
．A brief summary of the sterilization method should be included.
7. Note
．Only pre-clinical studies are required for class B products, and risk assessments are only required to provide risk analysis and its results.
．If the class C products are implantable devices, new devices, devices containing new substances and in direct contact with patients, etc., clinical trial evidence must be provided. A biological assessment report is required. Risk assessment requirements include a complete risk analysis, risk assessment and risk reduction measures.
．Class D products must provide clinical trial evidence. Attached is a reference list of past public reports on product use, safety, and efficacy. Risk assessment requirements include a complete risk analysis, risk assessment and risk reduction measures.
． Documents and labels shall be provided in English.
． CMDR certification is valid for 5 years, must be renewed every five years after initial approval, and extensions can be submitted 90 days prior to expiration.
Label
1. According to the specific medical equipment and intended use, it should be placed in the appropriate position in the following form:
．Where appropriate, the information needed to identify and safely use the medical device should be provided on the medical device itself. If this is not feasible or appropriate, some or all of the information may appear on the packaging of each unit (primary packaging) and/or on the outer packaging of multiple medical devices packaged together (secondary packaging).
．If individual packaging of each unit is not feasible or appropriate, the information should be listed in the Instructions for Use (IFU) (e.g. leaflet, package insert, manual or other provided media.)
．If the product owner provides multiple medical devices to a single user and/or location, it may be sufficient and appropriate to provide them with only one copy of the instructions for use. In these cases, the medical device user should be entitled to additional copies.
2. The medium, format, content, readability and location of the label shall be appropriate for the specific medical device, intended use and technical knowledge, experience, education or training of the intended user. In particular, instructions for use should be written in a language that is easily understood by the intended users, supplemented by drawings and diagrams where appropriate. Some medical devices may require separate information for healthcare professionals and laypeople.
3. An Instruction for Use (IFU) may not be required if it can be safely used as intended by the product owner in the absence of any such instructions, or it may be used for a low or medium risk medical device.
4. A paper version/hard copy of all labels should accompany the medical device.
5. Any residual risk identified in the risk analysis should be reflected on the label as a contraindication, caution or warning.
6. The use of internationally recognized symbols is encouraged, provided that medical device safety is not compromised by lack of understanding by patients or users. The meaning of the symbols is not obvious to the user of the medical device, e.g. an explanation should be provided for non-expert users or newly introduced symbols.
7. All characters on the label should be of sufficient size and clear printing.
8. Product labels should be written in English and/or Filipino.
9. The color contrast of the label and the packaging background, and the design must not obscure the information.
10. For medical device software, user instructions should be provided in the form of an electronic data storage device such as a compact disc, digital video disc, or USB flash drive/or other media.
11. For information that can be downloaded from the Internet, the Internet URL should be clearly printed on the physical label of the device and displayed in a way that highlights its purpose to the user. Product owners should ensure that the content of the electronic label is consistent with the paper format (if applicable) submitted with the product registration application. Users and/or other interested parties may also access the paper version of the IFU upon request.
12. The label must not contain any statement (or any organization thereof) that directly or indirectly indicates that the medical device is placed on the market, the use or operation of the medical device is being promoted or endorsed by the Ministry of Health – Food and Drug Administration.
13. The following specific contents should be marked on the packaging of medical equipment:
．Product name, trade name, or brand name to allow the user to identify the medical device.
．Product owner’s name, address, and contact information (such as phone numbers and web addresses for technical assistance).
．Medical device notification number certificate or medical device registration number issued by FDA-CDRRHR on all levels of packaging.
．The name and address of the importer and/or distributor. All levels of packaging are mandatory unless sterility and self-life are compromised.
．Sufficient details for the user to identify the medical device.
．Lot number, lot number or serial number (if applicable).
．The expiration date is at least a year and a month (for example, November 2020).
．Special storage/container, handling conditions and/or storage conditions.
．Date of manufacture in at least year and month.
．Information required to verify that a medical device is properly installed and able to function correctly and safely, including details of its nature. Frequency of preventive and scheduled maintenance, any quality control, replacement of consumable components and calibration required to ensure proper and safe operation of the medical device over its expected life (if applicable)
．The performance expected by the product owner, and any associated adverse side effects.
．The medical device may be used prior to any further processing or processing details required (eg, sterilization, final assembly, calibration, preparation of reagents and/or control materials, etc.).
．Labeling and sterilization methods for sterile medical devices (e.g., aseptic processing techniques; sterilization with ethylene oxide; sterilization with irradiation and/or sterilization with steam or dry heat); information on what to do if sterile packaging is damaged; and Instructions for resterilization (if applicable).
．Disposable medical device label specified by the product owner.
．Labeling of reusable medical devices, information on the appropriate process for allowing reuse, including cleaning, sterilization, packaging, and appropriate re-sterilization methods and any limitations on the number of reuses.
．Sterilization requirements and cleaning and sterilization process instructions for medical equipment before use.
．The label and date of refurbishment of refurbished medical equipment should be noted.
．Labeling of custom medical devices and claims for use by qualified practitioners.
．If the medical device is intended for clinical investigation, or for IVD medical devices, indicate that it is for performance evaluation only.
．If a medical device is intended for research use only and for display or demonstration purposes only, it should be marked: Not for human use.
．If the medical device is for research use only, it must be marked for research use only.
．Special risks associated with implanting implantable medical devices.
．If a medical device emits radiation for medical purposes, the intensity and distribution of that radiation should be specified in its nature, type and where appropriate. The radiation symbol on the specific part of the medical device (eg X-ray tube) that will be produced by the radiation source should also be indicated.
．Information about the risk of mutual interference (such as electromagnetic interference from other equipment) caused by the reasonably foreseeable presence of medical equipment during a particular investigation, evaluation, treatment or use.
．If the medical device is to be installed or connected with other medical devices or equipment or special software in order to function as required by its intended use, sufficient detail of its characteristics to identify the correct medical device or device use for a safe combination.
．In vitro diagnostic medical equipment shall be marked with in vitro diagnosis.
【參考連結】
https://www.fda.gov.ph/downloadables/
HLF-ph-45
HLF-ph-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?Website?
Evershine RD：
進口醫療器材需由製造商授權菲律賓當地企業依照醫療器材的分類，向FDA提出通知或完成產品註冊。
A 類醫療器材需完成通知，取得醫療設備通知證書 (CMDN)。B、C、D類器材需註冊，取得醫療器材註冊證書(CMDR)。
A 類醫療器材通知(CMDN)
1.申請人：製造商授權菲律賓當地企業(需具備經營許可證)。
2.申請網頁：FDA e-portal線上提交
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3.申請流程：
．申請者需具備有效LTO，以註冊CPR。
．獲得e-portal帳號及密碼。
．提交產品原料等相關資料。
．文件評估，如果所有文件都準確無誤，FDA 將頒發 CMDN。
4.法律要求
．公證申請表。
．付款。
．授權書副本，進口醫療器材授權書副本應附有合法生產商或產品所有人出具的授權真實無誤的公證聲明原件。
．政府頒發證明製造商在人員和設施的能力和可靠性方面的地位的證書、質量體系批准證書或 ISO 13485 合規證書。對於進口醫療器材，副本證書應附有合法製造商或產品所有者出具的證明證書真實無誤的公證聲明原件。
．原產國監管機構或認可的公告機構出具的產品通知證書、產品註冊證書或證明該器材安全性和有效性的任何等效文件。證書副本應附有合法製造商或產品所有人出具的證明該證書真實無誤的公證聲明原件。
．設備各方面的彩色圖片，可能需要有代表性的樣品或商業演示來進行驗證。
．醫療器材產品免費銷售證明。
5.申請表內容
．設備名稱。
．設備專有/品牌名稱。
．型號/參考編號/屬性代碼/項目代碼。
．設備的預期用途。
．申請人公司名稱、地址。
．LTO 編號有效期。
．電話號碼、傳真、電子郵件地址。
．公司負責人/總經理。
．監管人。
．合法製造商(產品持有人) 、地址。
．生產現場。
．簽署聲明。
6. 技術要求
．設備描述：預期用途、使用說明。
．所有原材料清單。
．成品技術規格。
．參考代碼、尺寸、顏色、型號和差異的列表(以適用者為準) 。
．政府機構頒發與計量相關製造方面的合格證書(如適用) 。
．符合產品標準的符合性聲明/製造商的自我聲明(如適用) 。
．清晰完整標籤彩色圖片。
．保質期聲明。
7.備註
．文件和標籤應以英文提供。
．CMDN認證有效期為 5 年，必須在初始批准後每五年更新一次，可以在到期前90天提交展延。
B、C、D類醫療器材註冊(CMDR)
1.申請人：製造商授權菲律賓當地企業(需具備經營許可證)。
2.申請網頁：以 CSDT 格式通過電子郵件提交檔案，FDA將審查申請。
3.申請流程：
．申請者需具備有效LTO，以註冊CPR。
．獲得e-portal帳號及密碼。
．提交產品原料等相關資料。
．文件評估，如果所有文件都準確無誤，FDA 將頒發 CMDN。
4.法律要求
．公證申請表
．付款
．授權書副本，進口醫療器材授權書副本應附有合法生產商或產品所有人出具的授權真實無誤的公證聲明原件。
．政府頒發證明製造商在人員和設施的能力和可靠性方面的地位的證書、質量體系批准證書或 ISO 13485 合規證書。對於進口醫療器材，副本證書應附有合法製造商或產品所有者出具的證明證書真實無誤的公證聲明原件。
．原產國監管機構或認可的公告機構出具的產品通知證書、產品註冊證書或證明該器材安全性和有效性的任何等效文件。證書副本應附有合法製造商或產品所有人出具的證明該證書真實無誤的公證聲明原件。
．設備各方面的彩色圖片，可能需要有代表性的樣品或商業演示來進行驗證。
．醫療器材產品免費銷售證明。
5.申請表內容
．設備名稱
．設備專有/品牌名稱
．型號/參考編號/屬性代碼/項目代碼
．分類：B類/C類/D類
．設備的預期用途
．申請人公司名稱、地址
．LTO 編號有效期
．電話號碼、傳真、電子郵件
．公司負責人/總經理
．監管人
．合法製造商(產品持有人) 、地址
．生產現場
．簽署聲明
6.技術要求
．執行摘要：概述、商業營銷史、標籤中的預期用途和指示、獲得的監管批准或營銷許可清單、任何未決的市場清關請求的狀態、重要的安全/性能相關信息。
．用於證明符合性的相關基本原則和方法(如果適用)。
．設備描述：預期用途、使用適應症、使用說明、禁忌症、警告、預防措施、潛在的不利影響、替代療法(實踐和程序)。
．材料：包括設備材料的完整化學、生物和物理特性。
．設備的功能特性和技術性能規格，包括相關的：測量和診斷醫療設備的準確性、靈敏度、特異性、可靠性和其他因素
．包括化學、物理、電氣、機械、生物、軟件、無菌、穩定性、儲存和運輸以及包裝(如果適用)。
．符合相關基本原則的其他描述性信息(例如：成品醫療器材的生物相容性類別)(如果適用)。
．符合製造商發布的產品標準的聲明/證書。
．基於其他標準、製造商方法和測試或證明合規性的替代方法的測試和評估的摘要或報告，例如從已發表的報告中列出的、涉及醫療器材方面的安全和性能的報告和參考的結論基本原則。
．涵蓋以下適當測試報告的數據摘要或測試報告和評估，以適用者為準：工程試驗、實驗室測試、生物相容性試驗、動物試驗、模擬使用、軟件驗證、臨床前研究。
．清晰完整包裝各個角度的標籤彩色圖片(散裝標籤或各層包裝的樣品)
．包含結果的風險分析。
．物理製造商信息製造過程，包括質量保證措施。這應包括製造方法和程序、製造環境或條件、設施和控制。該信息可以以工藝流程圖的形式呈現，該流程圖顯示了成品醫療器材的生產、控制、組裝、最終產品測試和包裝的概述。
．應包括對滅菌方法的簡要總結。
7.備註
．B等級產品僅須提供臨床前研究，風險評估僅須提供風險分析及其結果。
．C等級產品如屬於植入式器材、新進器材、含有新物質且與病患直接接觸之器材等，須提供臨床試驗證據。需檢附生物性評估報告。風險評估要求包含完整的風險分析、風險評估及減少風險措施。
．D等級產品均須提供臨床試驗證據。檢附過去有關產品使用、安全、效能之公開報告的參考目錄。風險評估要求包含完整的風險分析、風險評估及減少風險措施。
．文件和標籤應以英文提供。
． CMDR 認證有效期為 5 年，必須在初始批准後每五年更新一次，可以在到期前90天提交展延。
標籤
1.應根據特定的醫療器材及預期用途，按以下形式放置在適當位置：
．在適當的情況下，應在醫療器材本身上提供識別、安全使用醫療器材所需的信息。如果這不可行或不合適，部分或全部信息可能會出現在每個單元的包裝(初級包裝)和/或包裝在一起的多個醫療器材的外包裝上(二級包裝)。
．如果每個單元的單獨包裝不可行或不合適，則應在使用說明 (IFU) 中列出信息(例如傳單、包裝插頁、手冊或其他提供的介質。)
．如果產品所有者向單個用戶和/或位置提供多個醫療設備，則僅向他們提供一份使用說明的副本可能就足夠且適當。在這些情況下，醫療器材用戶應有權取得更多副本。
2. 標籤的媒介、格式、內容、可讀性和位置應適合特定的醫療器材、預期用途以及預期用戶的技術知識、經驗、教育或培訓。特別是，使用說明應以預期用戶易於理解的語言編寫，並在適當時輔以圖紙和圖表。一些醫療設備可能需要為醫療保健專業人員和非專業人士提供單獨的信息。
3. 如果在沒有任何此類說明的情況下可以按照產品所有者的意圖安全使用，則可能不需要使用說明 (IFU)，或者可以將其用於低風險或中等風險的醫療設備。
4. 所有標籤的紙質版本/硬拷貝應隨附醫療器材。
5. 風險分析中識別出的任何殘餘風險應在標籤中體現為禁忌症、注意事項或警告。
6. 鼓勵使用國際公認的符號，前提是醫療器材安全不會因患者或用戶缺乏理解而受到影響。符號的含義對醫療器材用戶來說並不明顯，例如：對於非專業用戶或新引入的符號，應提供解釋。
7. 標籤上的所有字符都應具有足夠的尺寸和清晰的印刷。
8. 產品標籤應以英文和/或菲律賓文書寫。
9. 標籤與包裝背景的顏色對比，設計不得掩蓋信息。
10. 對於醫療器材軟件，用戶說明應以電子數據存儲設備(如光盤、數字視頻光盤或 USB 閃存驅動器/或其他媒體)形式提供。
11. 對於可從互聯網下載的信息，互聯網網址應清楚地印在設備的物理標籤上，並以向用戶突出其目的的方式顯示。產品所有者應確保電子標籤的內容與隨產品註冊申請提交的紙質格式(如適用)一致。用戶和/或其他相關方也可以根據要求訪問 IFU 的紙質版本。
12. 標籤不得包含任何直接或間接表明該醫療器材在市場上的投放、醫療器材的使用或操作正在由衛生部 – 食品和藥物管理局推廣或認可的任何聲明(或其任何組織機構)。
13.醫療器材包裝上應標註的下列具體內容：
．產品名稱、商品名稱或品牌名稱，以允許用戶識別醫療器材。
．產品所有者的姓名、地址和聯繫方式(例如電話號碼和獲取技術幫助的網址)。
．FDA-CDRRHR在各級包裝上頒發的醫療器材通知號證明或醫療器材註冊證號。
．進口商和/或分銷商的名稱和地址。除非無菌性和自身壽命受到影響，否則所有級別的包裝都是強制性的。
．用戶識別醫療器材的足夠詳細信息。
．批號、批號或序列號(如適用)。
．到期日期至少以年和月表示(例如 2020 年 11 月)。
．特殊儲存/容器、處理條件和/或儲存條件。
．製造日期至少以年和月表示。
．驗證醫療器材是否正確安裝以及是否能夠正確和安全運行所需的信息，包括性質的詳細信息。預防性和定期維護的頻率，任何質量控制、消耗性組件的更換和校準所需的校準確保醫療設備在其預期壽命內正常安全運行(如果適用)
．產品所有者預期的性能，以及相關的任何不良副作用。
．醫療器材可以使用之前所需的任何進一步處理或處理的詳細信息(例如，滅菌、最終組裝、校準、試劑和/或控製材料的製備等)。
．無菌醫療器材的標示和滅菌方法(例如：無菌加工技術滅菌；使用環氧乙烷滅菌；使用輻照滅菌和/或使用蒸汽或乾熱滅菌)；有關如果無菌包裝損壞該怎麼辦的信息；以及重新滅菌的說明(如果適用)。
．產品所有者指定的一次性醫療器材標示。
．可重複使用的醫療器材的標示，允許重複使用的適當過程的信息，包括清潔、消毒、包裝，以及適當的再消毒方法和重複使用次數的任何限制。
．醫療器材使用前的滅菌要求和清洗、滅菌工藝說明。
．應當註明翻新醫療器材的標示和翻新日期。
．定制醫療器材的標示和由合格從業者使用的聲明。
．如果醫療器材旨在用於臨床調查，或者對於 IVD 醫療器材，則需表明僅用於性能評估。
．如果醫療器材旨在僅用於研究和僅用於展示或演示目的，則應標註：不得用於人體。
．如果醫療器材僅供研究使用，則必須標明僅供研究使用。
．與植入可植入醫療器材有關的特殊風險。
．如果醫療器材為醫療目的發射輻射，應在其性質、類型和適當情況下詳細說明該輻射的強度和分佈。輻射源將產生的醫療器材特定部分(例如 X 射線管)上的輻射符號也應標明。
．有關在特定調查、評估、治療或使用過程中合理可預見的醫療設備存在所造成的相互干擾風險的信息(例如來自其他設備的電磁干擾)。
．如果醫療器材要與其他醫療器材或設備或專用軟件一起安裝或連接，以便按其預期用途的要求運行，其特徵的足夠詳細信息以識別正確的醫療器材或設備使用以獲得安全的組合。
．體外診斷醫療器材應標註體外診斷。
Imported medical devices need to be authorized by the manufacturer to notify the FDA or complete the product registration according to the classification of the medical device. Class A medical devices are required to complete notification and obtain a Certificate of Medical Device Notification (CMDN). Class B, C, and D devices need to be registered, and a medical device registration certificate (CMDR) must be obtained.
Class A Medical Device Notification (CMDN)
1. Applicant: The manufacturer authorizes a local company in the Philippines (requires an operating license).
2. Application webpage: FDA e-portal online submission
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3. Application process:
．Applicants are required to have a valid LTO to register for CPR.
．Obtain e-portal account and password.
．Submit product materials and other relevant information.
．Document evaluation, if all documents are accurate, FDA will issue a CMDN.
4. Legal requirement
．Notary application form.
．Payment.
．A copy of the authorization letter, and the copy of the authorization letter for imported medical equipment should be accompanied by the original notarized statement of authorization issued by the legitimate manufacturer or product owner.
．A government-issued certificate certifying the manufacturer’s standing with respect to the competence and reliability of people and facilities, a quality system approval certificate, or an ISO 13485 compliance certificate. For imported medical devices, the duplicate certificate should be accompanied by the original notarized statement from the legal manufacturer or product owner certifying that the certificate is true.
．Product notification certificate, product registration certificate, or any equivalent document certifying the safety and effectiveness of the device, issued by the country of origin regulatory body or a recognized notified body. A copy of the certificate should be accompanied by the original notarized statement from the legitimate manufacturer or product owner certifying that the certificate is true.
．Color pictures of various aspects of equipment, representative samples or commercial demonstrations may be required for verification.
．Certificate of free sale of medical equipment products.
5. Contents of the application form
．Device name.
．Device proprietary/brand name.
．Model/Reference Number/Property Code/Item Code.
．Intended use of the device.
．Applicant’s company name and address.
．LTO number validity period.
．Phone number, fax, email address.
．Company manager/general manager.
．Supervisor.
．Legal manufacturer (product owner), address.
．Production site.
．Sign the statement.
6. Technical requirements
．Device description: Intended use, instructions for use.
．List of all raw materials.
．Finished technical specifications.
．Refer to a list of codes, sizes, colors, models and differences (whichever applies).
．Government agencies issue certificates of conformity with respect to metrology-related manufacturing, if applicable.
．Declaration of Conformity/Manufacturer’s Self-Declaration (if applicable) to the product standard.
．Clear and complete labels with color pictures.
．Shelf life statement.
7. Note
．Documentation and labels should be provided in English.
．CMDN certification is valid for 5 years and must be renewed every five years after initial approval, and extensions can be submitted 90 days prior to expiration.
Class B, C, D Medical Device Registration (CMDR)
1. Applicant: The manufacturer authorizes a local company in the Philippines (a business license is required).
2. Application Webpage: Submit the dossier by email in CSDT format, and FDA will review the application.
3. Application process:
．Applicants are required to have a valid LTO to register for CPR.
．Obtain e-portal account and password.
．Submit product materials and other relevant information.
．Document evaluation, if all documents are accurate, FDA will issue a CMDN.
4. Legal requirement
．Notary application form
．Payment
．A copy of the authorization letter, the copy of the authorization letter for imported medical equipment should be accompanied by the original notarized statement of authorization issued by the legal manufacturer or product owner.
．Government-issued certificates certifying the manufacturer’s standing with respect to the competence and reliability of people and facilities, quality system approvals, or ISO 13485 compliance. For imported medical devices, the duplicate certificate should be accompanied by the original notarized statement from the legal manufacturer or product owner certifying the authenticity of the certificate.
．Product notification certificate, product registration certificate, or any equivalent document certifying the safety and efficacy of the device, issued by the country of origin regulatory body or recognized notified body. A copy of the certificate should be accompanied by the original notarized statement from the legitimate manufacturer or product owner certifying the authenticity of the certificate.
．Color pictures of various aspects of the device, a representative sample or commercial demonstration may be required for verification.
．Certificate of free sale of medical equipment products.
5. Contents of the application form
．Device name
．Device Proprietary/Brand Name
．Model / Reference Number / Property Code / Item Code
．Classification: Class B/Class C/Class D
．Intended use of the device
．Applicant company name and address
．LTO number validity period
．Phone number, fax, email
．Company person/general manager
．Supervisor
．Legal manufacturer (product owner), address
．Production site
．Sign the statement
6. Technical requirements
．Executive Summary: Overview, Commercial Marketing History, Intended Use and Indications on Labels, List of Regulatory Approvals or Marketing Authorizations Obtained, Status of Any Pending Market Clearance Requests, Important Safety/Performance Related Information.
．Relevant underlying principles and methods used to demonstrate compliance, if applicable.
．Device Description: Intended Use, Indications for Use, Instructions for Use, Contraindications, Warnings, Precautions, Potential Adverse Effects, Alternative Therapies (Practices and Procedures).
．Materials: Includes complete chemical, biological, and physical properties of device materials.
．Functional characteristics and technical performance specifications of devices, including related: accuracy, sensitivity, specificity, reliability and other factors for measuring and diagnosing medical devices
．Includes chemical, physical, electrical, mechanical, biological, software, sterility, stability, storage and shipping, and packaging (if applicable).
．Other descriptive information (e.g., biocompatibility class of finished medical device) consistent with relevant underlying principles, if applicable.
．Declaration/Certificate of compliance with the manufacturer’s published product standards.
．Summaries or reports of tests and evaluations based on other standards, manufacturer’s methods and tests or alternative methods of demonstrating compliance, such as those listed and referenced from published reports dealing with the safety and performance of medical devices Conclusion basic principles.
．Data summaries or test reports and evaluations covering the following appropriate test reports, whichever is applicable: engineering testing, laboratory testing, biocompatibility testing, animal testing, simulated use, software validation, preclinical studies.
．Color pictures of the labels from all angles of the clear and complete package (bulk labels or samples of each layer of packaging)
．Risk analysis with results.
．Physical manufacturer information on the manufacturing process, including quality assurance measures. This should include manufacturing methods and procedures, manufacturing environment or conditions, facilities and controls. This information can be presented in the form of a process flow diagram showing an overview of the production, control, assembly, final product testing and packaging of the finished medical device.
．A brief summary of the sterilization method should be included.
7. Note
．Only pre-clinical studies are required for class B products, and risk assessments are only required to provide risk analysis and its results.
．If the class C products are implantable devices, new devices, devices containing new substances and in direct contact with patients, etc., clinical trial evidence must be provided. A biological assessment report is required. Risk assessment requirements include a complete risk analysis, risk assessment and risk reduction measures.
．Class D products must provide clinical trial evidence. Attached is a reference list of past public reports on product use, safety, and efficacy. Risk assessment requirements include a complete risk analysis, risk assessment and risk reduction measures.
． Documents and labels shall be provided in English.
． CMDR certification is valid for 5 years, must be renewed every five years after initial approval, and extensions can be submitted 90 days prior to expiration.
Label
1. According to the specific medical equipment and intended use, it should be placed in the appropriate position in the following form:
．Where appropriate, the information needed to identify and safely use the medical device should be provided on the medical device itself. If this is not feasible or appropriate, some or all of the information may appear on the packaging of each unit (primary packaging) and/or on the outer packaging of multiple medical devices packaged together (secondary packaging).
．If individual packaging of each unit is not feasible or appropriate, the information should be listed in the Instructions for Use (IFU) (e.g. leaflet, package insert, manual or other provided media.)
．If the product owner provides multiple medical devices to a single user and/or location, it may be sufficient and appropriate to provide them with only one copy of the instructions for use. In these cases, the medical device user should be entitled to additional copies.
2. The medium, format, content, readability and location of the label shall be appropriate for the specific medical device, intended use and technical knowledge, experience, education or training of the intended user. In particular, instructions for use should be written in a language that is easily understood by the intended users, supplemented by drawings and diagrams where appropriate. Some medical devices may require separate information for healthcare professionals and laypeople.
3. An Instruction for Use (IFU) may not be required if it can be safely used as intended by the product owner in the absence of any such instructions, or it may be used for a low or medium risk medical device.
4. A paper version/hard copy of all labels should accompany the medical device.
5. Any residual risk identified in the risk analysis should be reflected on the label as a contraindication, caution or warning.
6. The use of internationally recognized symbols is encouraged, provided that medical device safety is not compromised by lack of understanding by patients or users. The meaning of the symbols is not obvious to the user of the medical device, e.g. an explanation should be provided for non-expert users or newly introduced symbols.
7. All characters on the label should be of sufficient size and clear printing.
8. Product labels should be written in English and/or Filipino.
9. The color contrast of the label and the packaging background, and the design must not obscure the information.
10. For medical device software, user instructions should be provided in the form of an electronic data storage device such as a compact disc, digital video disc, or USB flash drive/or other media.
11. For information that can be downloaded from the Internet, the Internet URL should be clearly printed on the physical label of the device and displayed in a way that highlights its purpose to the user. Product owners should ensure that the content of the electronic label is consistent with the paper format (if applicable) submitted with the product registration application. Users and/or other interested parties may also access the paper version of the IFU upon request.
12. The label must not contain any statement (or any organization thereof) that directly or indirectly indicates that the medical device is placed on the market, the use or operation of the medical device is being promoted or endorsed by the Ministry of Health – Food and Drug Administration.
13. The following specific contents should be marked on the packaging of medical equipment:
．Product name, trade name, or brand name to allow the user to identify the medical device.
．Product owner’s name, address, and contact information (such as phone numbers and web addresses for technical assistance).
．Medical device notification number certificate or medical device registration number issued by FDA-CDRRHR on all levels of packaging.
．The name and address of the importer and/or distributor. All levels of packaging are mandatory unless sterility and self-life are compromised.
．Sufficient details for the user to identify the medical device.
．Lot number, lot number or serial number (if applicable).
．The expiration date is at least a year and a month (for example, November 2020).
．Special storage/container, handling conditions and/or storage conditions.
．Date of manufacture in at least year and month.
．Information required to verify that a medical device is properly installed and able to function correctly and safely, including details of its nature. Frequency of preventive and scheduled maintenance, any quality control, replacement of consumable components and calibration required to ensure proper and safe operation of the medical device over its expected life (if applicable)
．The performance expected by the product owner, and any associated adverse side effects.
．The medical device may be used prior to any further processing or processing details required (eg, sterilization, final assembly, calibration, preparation of reagents and/or control materials, etc.).
．Labeling and sterilization methods for sterile medical devices (e.g., aseptic processing techniques; sterilization with ethylene oxide; sterilization with irradiation and/or sterilization with steam or dry heat); information on what to do if sterile packaging is damaged; and Instructions for resterilization (if applicable).
．Disposable medical device label specified by the product owner.
．Labelling of reusable medical devices, information on the appropriate process for allowing reuse, including cleaning, sterilization, packaging, and appropriate re-sterilization methods and any limitations on the number of reuses.
．Sterilization requirements and cleaning and sterilization process instructions for medical equipment before use.
．The label and date of refurbishment of refurbished medical equipment should be noted.
．Labeling of custom medical devices and claims for use by qualified practitioners.
．If the medical device is intended for clinical investigation, or for IVD medical devices, indicate that it is for performance evaluation only.
．If a medical device is intended for research use only and for display or demonstration purposes only, it should be marked: Not for human use.
．If the medical device is for research use only, it must be marked for research use only.
．Special risks associated with implanting implantable medical devices.
．If a medical device emits radiation for medical purposes, the intensity and distribution of that radiation should be specified in its nature, type and where appropriate. The radiation symbol on the specific part of the medical device (eg X-ray tube) that will be produced by the radiation source should also be indicated.
．Information about the risk of mutual interference (such as electromagnetic interference from other equipment) caused by the reasonably foreseeable presence of medical equipment during a particular investigation, evaluation, treatment or use.
．If the medical device is to be installed or connected with other medical devices or equipment or special software in order to function as required by its intended use, sufficient detail of its characteristics to identify the correct medical device or device use for a safe combination.
．In vitro diagnostic medical equipment shall be marked with in vitro diagnosis.
【參考連結】
https://www.fda.gov.ph/downloadables/
https://dmas.doh.gov.ph:8083/Rest/GetFile?id=605689
HLF-ph-55
HLF-ph-60
經過核准登記的醫療器材，進口到菲律賓要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What documents are required when importing approved medical devices into Philippines? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海關
1.進口商企業首先需要取得國稅局的進口清關證書，然後進口商在海關局 (BOC) 註冊，並在客戶資料註冊系統 (CPRS) 上開設一個帳戶。網頁：https://aeo.customs.gov.ph/
2.進口清關證書有效期為三年，而海關客戶資料認證必須每年更新。CPRS 認證費用為 P1000(20 美元)，通常需要 15 個工作日來處理。
3. 菲律賓海關對進口商品徵收 12% 的增值稅 (VAT)，對價值低於 P10,000(200 美元)的商品不徵收關稅或稅款。
4.進口到菲律賓的企業在貨物到達時必須提供以下文件：
．打包清單。
．發票。
．提貨單。
．海關進口申報。
．原產地證書。
．食品和藥物管理局的產品註冊證書。
．經正式公證的估價補充聲明 (SDV) 。
．自由貿易協定 (FTA) 的原產地證明。
．貨物報關單。
．稅收抵免證書 (TCC) 或稅收借記通知單 (TDM)(如果適用) 。
．經營許可證 (LTO)
．產品註冊證書 (CPR)
．FDA 認證/通知/許可(對於那些不需要 LTO 和/或 CPR 的人)
．分析證書(如適用)
5. 進口文件
．提單/空運提單，或船舶或飛機的承運人或代理人的證明。
．商業發票、信用證或任何其他可證明付款的商業文件。
．表明貨物商業價值的商業文件。
6. 對於信用證 (L/C) 交易，需要正式完成的信用證，包括形式發票和預先海關進口關稅的單一行政文件 (SAD)。
非信用證交易需要形式發票，例如承兌匯票 (D/A)、付款單據 D/P)、開立賬戶 (OA) 或自籌資金文件。
7.文件必須連同報關人和報關行(如有)簽署並公證的 SAD 打印件一起提交給海關正式入境處 (FED) 或其同等辦公室或單位。
Medical devices that do not have a sales license but have obtained a CMDN or CMDR license must be marked on the product before they are listed.
Customs
1. The importer business first needs to obtain the import clearance certificate from the Internal Revenue Service, and then the importer registers with the Bureau of Customs (BOC) and opens an account on the Customer Data Registration System (CPRS). Website: https://aeo.customs.gov.ph/
2. The import customs clearance certificate is valid for three years, and the customs customer data certification must be updated every year. CPRS certification costs P1000 ($20) and usually takes 15 business days to process.
3. Philippine Customs imposes a 12% Value Added Tax (VAT) on imported goods and no duties or taxes are levied on goods valued below P10,000 (US$200).
4. Enterprises importing into the Philippines must provide the following documents upon arrival of the goods:
．Packing list.
．Invoices.
．Bill of lading.
．Customs import declaration.
．Certificate of Origin.
．Product Registration Certificate from the Food and Drug Administration.
．Duly notarized Supplemental Statement of Valuation (SDV).
．Free Trade Agreement (FTA) certificate of origin.
．Goods declaration.
．Tax Credit Certificate (TCC) or Tax Debit Memo (TDM) (if applicable).
．License to operate (LTO)
．Certificate of Product Registration (CPR)
．FDA clearance/notification/license (for those who do not need LTO and/or CPR)
．Certificate of Analysis (if applicable)
5. Import Documentation
．Bill of lading/air waybill, or proof of the carrier or agent of the ship or aircraft.
．Commercial Invoice, Letter of Credit or any other commercial document to prove payment.
．A commercial document showing the commercial value of the goods.
6. For Letter of Credit (L/C) transactions, a duly completed letter of credit including pro forma invoice and Single Administrative Document (SAD) with pre-customs import duties is required. Proforma invoices are required for non-LC transactions, such as drafts of acceptance (D/A), payment documents (D/P), opening of accounts (OA), or self-funding documents.
7. The documents must be submitted to the Customs Official Entry Division (FED) or its equivalent office or unit together with a signed and notarized SAD printout of the customs broker and the customs broker (if any).
【參考連結】
https://www.fda.gov.ph/downloadables/
https://customs.gov.ph/wp-content/uploads/2016/09/Import-Transaction-Overview-Infographic_v1.0.pdf
HLF-ph-70
菲律賓醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1.製造商符合ISO 13485
．一般要求(商業執照、許可證、相關證明文件等)
． 文件要求(ISO流程紀錄、醫療器材紀錄、質量控制程序、文件控制程序、質量目標、質量方針、質量手冊、部門應用流程/表格、內部門審計紀錄等)
．管理責任(部門、負責人及職責)
．資源
．產品實現
．基礎設施
．風險管理
2.東協共同提交檔案模板（CSDT）
．執行摘要：概述、商業營銷歷史、標籤中的預期目的和指示、獲得的監管批准或營銷許可清單、任何未決的市場清關請求的狀態、重要的安全/性能相關信息。
．證明符合性的相關基本原則和方法：基本原則和符合性證據。
．醫療器械說明：醫療設備描述和功能、預期目的、適應症、使用說明、禁忌症、警告、預防措施、潛在的不利影響、替代療法、材料、其他相關規格、其他描述性信息。
．設計驗證和確認文件摘要：臨床前研究、軟件驗證和確認研究（如果適用）、含有生物材料的醫療器械、臨床證據、使用現有參考書目。
．醫療器械標籤：醫療器械及其包裝標籤樣本、使用說明。
．風險分析：風險分析結果。
．製造商信息：製造工藝。
1. Manufacturer complies with ISO 13485
．General requirements (business licenses, permits, relevant supporting documents, etc.)
．Documentation requirements (ISO process records, medical device records, quality control procedures, document control procedures, quality objectives, quality policy, quality manuals, departmental application procedures/forms, internal departmental audit records, etc.)
．Management responsibilities (departments, responsible persons and responsibilities)
．Resource
．Product realization
．Infrastructure
．Risk Management
2. ASEAN Common Submission Dossier Template (CSDT)
．Executive Summary: Overview, commercial marketing history, intended purpose and indications in the label, list of regulatory approvals or marketing clearances obtained, status of any pending market clearance requests, important safety/performance related information.
．Relevant basic principles and methods for demonstrating compliance: Basic principles and evidence of compliance.
．Medical Device Description: Medical Device Description and Function, Intended Purpose, Indications, Instructions for Use, Contraindications, Warnings, Precautions, Potential Adverse Effects, Alternative Therapies, Materials, Other Relevant Specifications, Other Descriptive Information.
．Design Validation and Validation Document Summary: Preclinical Studies, Software Validation and Validation Studies (if applicable), Medical Devices Containing Biomaterials, Clinical Evidence, Use of Existing Bibliography.
．Medical device labels: samples of medical devices and their packaging labels, instructions for use.
．Risk Analysis: The results of the risk analysis.
． Manufacturer Information: Manufacturing Process.
【參考連結】
https://asean.org/wp-content/uploads/2021/08/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
HLF-ph-75
HLF-ph-77
HLF-ph-80
外國子公司進口醫療器材後，如果委託菲律賓的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports medical devices and entrusts a distributor in Philippines to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
在菲律賓從事醫療器材銷售或零售的企業需要以當地企業名義從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊，外國公司可以設立法人子公司或指定當地經銷商，或者委任獨立第三方。
責任
1.醫療器材企業、製造商、分銷商、進口商、出口商、批發商都必須具備質量管理體系 (QMS) 和相關文件。
菲律賓 FDA 在其例行檢查期間對其進行檢查和審核。QMS 必須包括既定的風險管理計劃 (RMP) 和標準操作程序 (SOP) 及其相關表格，用於良好的存儲和分發、投訴處理、產品召回、醫療器材處置/銷毀。
2.報告不良事件的醫療器材公司將需要通過電子郵件將其 AE 報告發送給器材監管輻射健康與研究中心 (CDRRHR) 主任和產品研究與標準制定部 (PRSDD) 處長。FDA 評估員接受所有經銷商、製造商、所有者、設備最終用戶使用規定格式的報告。
3.評估員將針對不良事件/投訴向賣方、製造商或所有者發出糾正和預防措施 ( CAPA ) 並實施糾正措施。要求提交報告。
根據結果，可能會建議/監控或召回醫療設備。
4.發生在菲律賓境外的不良事件不需要向 PFDA 報告，除非用戶是菲律賓人並且設備是從菲律賓獲得的（或除非另有要求），並且僅說明事件發生的國家。
5.合格人員的責任
機構的合格人員應負責確保醫療器材的安全性、質量和有效性/性能，包括以下內容：
．遵守良好的儲存和分配做法以及其他相關和適用的做法。
．監控產品庫存，包括有效期（如適用）。
．確保患者/消費者經歷的任何不良事件都得到妥善處理、記錄並報告給企業的供應商/分銷商。導致或促成消費者、患者或任何人死亡、嚴重疾病或嚴重傷害的事件應通過設備監管、輻射健康和研究中心向食品和藥物管理局報告。
．確保所有出售的醫療器材產品均獲得 FDA 頒發的相應授權。
．確保企業遵守現有的 FDA 醫療器材法規和建議。
．在購買和銷售醫療器材之前，需要獲得機構供應商/分銷商的適當授權。
Companies engaged in the sales or retail of medical equipment in the Philippines need to obtain a license to operate (LTO) and complete product registration from the Philippine Food and Drug Administration (FDA) in the name of a local company. Foreign companies can set up legal entities or designate local distributors, or Appoint an independent third party.
Responsibility
1. Medical device companies, manufacturers, distributors, importers, exporters, wholesalers are required to have a Quality Management System (QMS) and related documents. The Philippines FDA inspects and audits it during its routine inspections. The QMS must include an established Risk Management Plan (RMP) and Standard Operating Procedure (SOP) and its associated forms for good storage and distribution, complaint handling, product recall, medical device disposal/destruction.
2. Medical device companies reporting adverse events will be required to email their AE reports to the Director of the Center for Device Regulatory Radiation Health and Research (CDRRHR) and the Director of the Product Research and Standards Development Department (PRSDD). FDA assessors accept reports in the prescribed format from all distributors, manufacturers, owners, equipment end users.
3. The assessor will issue a Corrective and Preventive Action (CAPA) to the seller, manufacturer or owner for the adverse event/complaint and implement corrective action. Request to submit a report. Depending on the results, medical devices may be recommended/monitored or recalled.
4. Adverse events that occur outside the Philippines do not need to be reported to PFDA unless the user is Filipino and the device was obtained from the Philippines (or unless otherwise requested), and only the country in which the event occurred is stated.
5. Responsibilities of Qualified Persons
Qualified personnel at the facility shall be responsible for ensuring the safety, quality, and efficacy/performance of medical devices, including the following:
．Follow good storage and distribution practices and other relevant and applicable practices.
．Monitor product inventory, including expiration dates (if applicable).
．Ensure that any adverse events experienced by the patient/consumer are properly handled, recorded and reported to the business’s supplier/distributor. Events that cause or contribute to the death, serious illness or serious injury of consumers, patients or anyone should be reported to the Food and Drug Administration through the Center for Device Regulation, Radiation Health and Research.
．Ensure that all medical device products sold are appropriately authorized by the FDA.
．Ensure that businesses comply with existing FDA medical device regulations and recommendations.
．Appropriate authorization from institutional suppliers/distributors is required before purchasing and selling medical equipment.
【參考連結】
HLF-ph-85
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Email：mnl4ww@evershinecpa.com
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菲律賓永輝BPO有限公司
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