菲律宾医疗器材登记法规问题集 -

菲律宾医疗器材登记法规问题集

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或
菲律宾永辉BPO有限公司
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HLF-ph-10请问菲律宾对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

HLF-ph-20外国公司要到菲律宾销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

HLF-ph-30 外国公司要到菲律宾销售医疗器材，可以指派菲律宾公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

HLF-ph-40外国公司销售到菲律宾医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

HLF-ph-50外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

HLF-ph-60经过核准登记的医疗器材，进口到菲律宾要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

HLF-ph-70菲律宾医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

HLF-ph-80外国子公司进口医疗器材后，如果委託菲律宾的经销商销售，经销商需要医疗器材营业许可证吗？假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

各国医疗器材登记法规问答集

HLF-ph-10
请问菲律宾对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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：

菲律宾医疗器材主管机关为食品药物管理局(FDA)，辖下的医疗器材管理与放射卫生研究中心(CDRRHR)，负责管理境内医疗器材与设备的生产、进出口、分销、促销、广告、销售等活动，以及法规制定、技术评估与许可产品的上市后监督。

医疗器材是指製造为单独或组合用于人类的任何仪器、装置、器具、机器、器具、植入物、体外试剂或校准器、软件、材料或其他类似或相关物品，用于以下一个或多个特定目的：

1.诊断、预防、监测、治疗或缓解疾病。

2.损伤的诊断、监测、治疗、减轻或补偿。

3.解剖结构或生理过程的调查、替换、修改或支持。

4.支持或维持生命。

5.预防感染。

6.控制受孕。

7.医疗器材消毒。

8.通过对人体标本进行体外检查，为医疗或诊断目的提供信息。

该装置不能通过药理学、免疫学或代谢手段在人体内或人体上实现其主要预期作用，但可以通过这些手段辅助其达到预期功能。

医疗器材按照与设计和製造相关的潜在风险等级分为以下四类：

1. A 级：低风险。

2. B 类：中低风险。

3. C级：中高风险。

4. D 级：高风险。

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.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2022/06/The-Rules-and-Regulations-Implementing-Republic-Act-No.-9711-%C2%AD-The-Food-and-Drug-Administration-Act-of-2009.pdf

HLF-ph-20
外国公司要到菲律宾销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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。在菲律宾从事医疗器材销售或零售的企业需要从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

经营许可证(LTO)

1.申请人：菲律宾当地企业。

2.申请网页：FDA e-portal https://eportal.fda.gov.ph

3.註册资料

．电子邮件

．授权公司名称、代表姓名、职位、联繫电话

．授权书扫描档(pdf)

4. LTO申请文件

．经销商的公证申请表与联合承诺书

．承诺书的电子副本

．营业许可证(商业名称註册证明)

．进口或配销之医疗器材产品清单

．医疗器材销售证明影本

．办公室或仓储位置图与平面图

．申请人或国内授权代表之照片

．国外製造商之GMP证书以及相关ISO认证之文件与证明，且须经菲律宾领事合法公证

．国外製造商与菲律宾当地经销商的代理协议

．风险管理计划

．费用支付

5.申请文件

．公司名称、邮寄地址

．电话号码

．传真号码

．电子邮件

．在现场製造和/或重新包装的实际产品类型，提及它们的加工方式

．网站的简短描述

．位置规划和周边环境

．平面图和建筑类型

．从事质量保证、质量控制、生产、储存和配送、技术和工程支持服务的员工人数

．在製造和分析以及重新包装方面使用外部科学、分析或其他技术援助

．显示质量保证安排的组织结构图，包括生产和质量控制

．关键人员的资格、经验和职责

．基本和在职培训的安排大纲以及记录的保存方式

．从事生产人员的健康要求

．人员卫生要求，包括衣物和更衣区

．场地和设备

．具有规模的製造区域的计划或描述

．结构和饰面的性质

．通风系统的简要说明。对于具有潜在空气汙染风险的关键区域，应提供更多详细信息。应该提到用于製造无菌产品的房间的分类。

．处理剧毒、危险和敏感材料的特殊区域

．计划的预防性、纠正性和预测性维护计划和记录系统

．主要生产及受控实验室设备简述

．资格和校准，包括记录系统

．清洁製造区域和设备的书面程序

．使用流程图和图表简要描述生产操作

．起始材料、包装材料、散装和成品的安排，包括取样、检疫、放行和储存

．再加工或返工安排

．处理拒收材料和产品的安排

．工艺验证一般政策的简要说明

．简述品管体系及品管部成品放行程序

．描述质量控制系统的要素，例如：规格、测试方法和其他与质量相关的集合

．简要描述分析测试、包装和组件测试的活动

．概述文件的准备、修订和分发的安排

．描述用于验证活动是否符合既定标准以确保製造过程质量的自检系统

．验证质量体系的有效性

．确保存在自检系统和后续行动的书面程序

．确保与被检查区域的负责人讨论自我检查系统的结果并验证活动的文件

．文件将确保该地区或活动的负责人对注意到的缺陷採取及时的纠正措施

．编制、修订和分发文件的安排

．文件系统描述

．负责文件的准备、修订和分发

．主文件的存储

．文件准备程序

．文件控制

．与产品质量有关

．设备规格

．标准作业程序

．质量控製程序

．培训程序

．过程偏差的文档控制

．校准和测试文件

．验证文件

．原材料批次、主要包装组件的核对

．分销、投诉和产品召回

6. 许可后检查

在营业时间内接受 FDA 授权人员的例行或抽查检查。检查时应核对下列文件：

．商业名称註册证明

．营业执照（如果企业地址与企业名称註册地址不同）

．合格人员的证书

．由学术界或工业界提供的关于医疗器材安全、质量和使用的研讨会、培训、学习和发展活动的出席证书

．标准操作程序，包括监测医疗器材产品的质量并反映遵守良好储存和分销规范

．FDA签发的有效LTO

．销售的医疗器材的 CMDN/CMDR（如适用）副本

．风险管理计划等

7.备註

．企业应至少拥有一名合格人员(QP)，须为全职员工，有责任遵守 FDA 的技术要求，或在提交技术要求时与 FDA 讨论或澄清事项，或在进行检查或上市后监督 (PMS) 活动时与 FDA 官员接触。合格人员可以是企业的正式授权人员。

．业者须有实体据点，无实体据点之业者申请必定会遭驳回或撤销。

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

．E-mail

．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

．E-mail

．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.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2021/06/Guidelines-on-the-Licensing-of-Retailers-of-Medical-Devices-in-the-Philippines.pdf

https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/

HLF-ph-25

HLF-ph-30
外国公司要到菲律宾销售医疗器材，可以指派菲律宾公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？
所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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。在菲律宾从事医疗器材销售或零售的企业需要以当地企业名义从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册，外国公司可以设立法人子公司或指定当地经销商，或者委任独立第三方。

经营许可证(LTO)

1.申请人：菲律宾当地企业。

2.申请网页：FDA e-portal https://eportal.fda.gov.ph

3.註册资料

．电子邮件

．授权公司名称、代表姓名、职位、联繫电话

．授权书扫描档(pdf)

4. LTO申请文件

．经销商的公证申请表与联合承诺书

．承诺书的电子副本

．营业许可证(商业名称註册证明)

．进口或配销之医疗器材产品清单

．医疗器材销售证明影本

．办公室或仓储位置图与平面图

．申请人或国内授权代表之照片

．国外製造商之GMP证书以及相关ISO认证之文件与证明，且须经菲律宾领事合法公证

．国外製造商与菲律宾当地经销商的代理协议

．风险管理计划

．费用支付

5.申请文件

．公司名称、邮寄地址

．电话号码

．传真号码

．电子邮件

．在现场製造和/或重新包装的实际产品类型，提及它们的加工方式

．网站的简短描述

．位置规划和周边环境

．平面图和建筑类型

．从事质量保证、质量控制、生产、储存和配送、技术和工程支持服务的员工人数

．在製造和分析以及重新包装方面使用外部科学、分析或其他技术援助

．显示质量保证安排的组织结构图，包括生产和质量控制

．关键人员的资格、经验和职责

．基本和在职培训的安排大纲以及记录的保存方式

．从事生产人员的健康要求

．人员卫生要求，包括衣物和更衣区

．场地和设备

．具有规模的製造区域的计划或描述

．结构和饰面的性质

．通风系统的简要说明。对于具有潜在空气汙染风险的关键区域，应提供更多详细信息。应该提到用于製造无菌产品的房间的分类。

．处理剧毒、危险和敏感材料的特殊区域

．计划的预防性、纠正性和预测性维护计划和记录系统

．主要生产及受控实验室设备简述

．资格和校准，包括记录系统

．清洁製造区域和设备的书面程序

．使用流程图和图表简要描述生产操作

．起始材料、包装材料、散装和成品的安排，包括取样、检疫、放行和储存

．再加工或返工安排

．处理拒收材料和产品的安排

．工艺验证一般政策的简要说明

．简述品管体系及品管部成品放行程序

．描述质量控制系统的要素，例如：规格、测试方法和其他与质量相关的集合

．简要描述分析测试、包装和组件测试的活动

．概述文件的准备、修订和分发的安排

．描述用于验证活动是否符合既定标准以确保製造过程质量的自检系统

．验证质量体系的有效性

．确保存在自检系统和后续行动的书面程序

．确保与被检查区域的负责人讨论自我检查系统的结果并验证活动的文件

．文件将确保该地区或活动的负责人对注意到的缺陷採取及时的纠正措施

．编制、修订和分发文件的安排

．文件系统描述

．负责文件的准备、修订和分发

．主文件的存储

．文件准备程序

．文件控制

．与产品质量有关

．设备规格

．标准作业程序

．质量控製程序

．培训程序

．过程偏差的文档控制

．校准和测试文件

．验证文件

．原材料批次、主要包装组件的核对

．分销、投诉和产品召回

6. 许可后检查

在营业时间内接受 FDA 授权人员的例行或抽查检查。检查时应核对下列文件：

．商业名称註册证明

．营业执照（如果企业地址与企业名称註册地址不同）

．合格人员的证书

．由学术界或工业界提供的关于医疗器材安全、质量和使用的研讨会、培训、学习和发展活动的出席证书

．标准操作程序，包括监测医疗器材产品的质量并反映遵守良好储存和分销规范

．FDA签发的有效LTO

．销售的医疗器材的 CMDN/CMDR（如适用）副本

．风险管理计划等

7.备註

．业者须有实体据点，无实体据点之业者申请必定会遭驳回或撤销。

责任

1.医疗器材企业、製造商、分销商、进口商、出口商、批发商都必须具备质量管理体系 (QMS) 和相关文件。菲律宾 FDA 在其例行检查期间对其进行检查和审核。QMS 必须包括既定的风险管理计划 (RMP) 和标准操作程序 (SOP) 及其相关表格，用于良好的存储和分发、投诉处理、产品召回、医疗器材处置/销毁。

2.报告不良事件的医疗器材公司将需要通过电子邮件将其 AE 报告发送给器材监管辐射健康与研究中心 (CDRRHR) 主任和产品研究与标准制定部 (PRSDD) 处长。FDA 评估员接受所有经销商、製造商、所有者、设备最终用户使用规定格式的报告。

3.评估员将针对不良事件/投诉向卖方、製造商或所有者发出纠正和预防措施 ( CAPA ) 并实施纠正措施。要求提交报告。根据结果，可能会建议/监控或召回医疗设备。

4.发生在菲律宾境外的不良事件不需要向 PFDA 报告，除非用户是菲律宾人并且设备是从菲律宾获得的（或除非另有要求），并且仅说明事件发生的国家。

5.合格人员的责任

机构的合格人员应负责确保医疗器材的安全性、质量和有效性/性能，包括以下内容：

．遵守良好的储存和分配做法以及其他相关和适用的做法。

．监控产品库存，包括有效期（如适用）。

．确保患者/消费者经历的任何不良事件都得到妥善处理、记录并报告给企业的供应商/分销商。导致或促成消费者、患者或任何人死亡、严重疾病或严重伤害的事件应通过设备监管、辐射健康和研究中心向食品和药物管理局报告。

．确保所有出售的医疗器材产品均获得 FDA 颁发的相应授权。

．确保企业遵守现有的 FDA 医疗器材法规和建议。

．在购买和销售医疗器材之前，需要获得机构供应商/分销商的适当授权。

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

．E-mail

．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

．E-mail

．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

．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 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.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2021/06/Guidelines-on-the-Licensing-of-Retailers-of-Medical-Devices-in-the-Philippines.pdf

https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/

https://www.fda.gov.ph/wp-content/uploads/2022/05/LRD2_Annex-1_Site-Master-File.pdf

HLF-ph-35

HLF-ph-40
外国公司销售到菲律宾医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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：

进口医疗器材需由製造商授权菲律宾当地企业依照医疗器材的分类，向FDA提出通知或完成产品註册。
A 类医疗器材需完成通知，取得医疗设备通知证书 (CMDN)。B、C、D类器材需註册，取得医疗器材註册证书(CMDR)。

A 类医疗器材通知(CMDN)

1.申请人：製造商授权菲律宾当地企业(需具备经营许可证)。

2.申请网页：FDA e-portal线上提交

https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

3.申请流程：

．申请者需具备有效LTO，以註册CPR。

．获得e-portal帐号及密码。

．提交产品原料等相关资料。

．文件评估，如果所有文件都准确无误，FDA 将颁发 CMDN。

4.法律要求

．公证申请表。

．付款。

．授权书副本，进口医疗器材授权书副本应附有合法生产商或产品所有人出具的授权真实无误的公证声明原件。

．政府颁发证明製造商在人员和设施的能力和可靠性方面的地位的证书、质量体系批准证书或 ISO 13485 合规证书。对于进口医疗器材，副本证书应附有合法製造商或产品所有者出具的证明证书真实无误的公证声明原件。

．原产国监管机构或认可的公告机构出具的产品通知证书、产品註册证书或证明该器材安全性和有效性的任何等效文件。证书副本应附有合法製造商或产品所有人出具的证明该证书真实无误的公证声明原件。

．设备各方面的彩色图片，可能需要有代表性的样品或商业演示来进行验证。

．医疗器材产品免费销售证明。

5.申请表内容

．设备名称。

．设备专有/品牌名称。

．型号/参考编号/属性代码/项目代码。

．设备的预期用途。

．申请人公司名称、地址。

．LTO 编号有效期。

．电话号码、传真、电子邮件地址。

．公司负责人/总经理。

．监管人。

．合法製造商(产品持有人) 、地址。

．生产现场。

．签署声明。

6. 技术要求

．设备描述：预期用途、使用说明。

．所有原材料清单。

．成品技术规格。

．参考代码、尺寸、颜色、型号和差异的列表(以适用者为准) 。

．政府机构颁发与计量相关製造方面的合格证书(如适用) 。

．符合产品标准的符合性声明/製造商的自我声明(如适用) 。

．清晰完整标籤彩色图片。

．保质期声明。

7.备註

．文件和标籤应以英文提供。

．CMDN认证有效期为 5 年，必须在初始批准后每五年更新一次，可以在到期前90天提交展延。

B、C、D类医疗器材註册(CMDR)

1.申请人：製造商授权菲律宾当地企业(需具备经营许可证)。

2.申请网页：以 CSDT 格式通过电子邮件提交档案，FDA将审查申请。

cdrrhr@fda.gov.ph

3.申请流程：

．申请者需具备有效LTO，以註册CPR。

．获得e-portal帐号及密码。

．提交产品原料等相关资料。

．文件评估，如果所有文件都准确无误，FDA 将颁发 CMDN。

4.法律要求

．公证申请表

．付款

．授权书副本，进口医疗器材授权书副本应附有合法生产商或产品所有人出具的授权真实无误的公证声明原件。

．设备各方面的彩色图片，可能需要有代表性的样品或商业演示来进行验证。

．医疗器材产品免费销售证明。

5.申请表内容

．设备名称

．设备专有/品牌名称

．型号/参考编号/属性代码/项目代码

．分类：B类/C类/D类

．设备的预期用途

．申请人公司名称、地址

．LTO 编号有效期

．电话号码、传真、电子邮件

．公司负责人/总经理

．监管人

．合法製造商(产品持有人) 、地址

．生产现场

．签署声明

6.技术要求

．执行摘要：概述、商业营销史、标籤中的预期用途和指示、获得的监管批准或营销许可清单、任何未决的市场清关请求的状态、重要的安全/性能相关信息。

．用于证明符合性的相关基本原则和方法(如果适用)。

．设备描述：预期用途、使用适应症、使用说明、禁忌症、警告、预防措施、潜在的不利影响、替代疗法(实践和程序)。

．材料：包括设备材料的完整化学、生物和物理特性。

．设备的功能特性和技术性能规格，包括相关的：测量和诊断医疗设备的准确性、灵敏度、特异性、可靠性和其他因素

．包括化学、物理、电气、机械、生物、软件、无菌、稳定性、储存和运输以及包装(如果适用)。

．符合相关基本原则的其他描述性信息(例如：成品医疗器材的生物相容性类别)(如果适用)。

．符合製造商发布的产品标准的声明/证书。

．基于其他标准、製造商方法和测试或证明合规性的替代方法的测试和评估的摘要或报告，例如从已发表的报告中列出的、涉及医疗器材方面的安全和性能的报告和参考的结论基本原则。

．涵盖以下适当测试报告的数据摘要或测试报告和评估，以适用者为准：工程试验、实验室测试、生物相容性试验、动物试验、模拟使用、软件验证、临床前研究。

．清晰完整包装各个角度的标籤彩色图片(散装标籤或各层包装的样品)

．包含结果的风险分析。

．物理製造商信息製造过程，包括质量保证措施。这应包括製造方法和程序、製造环境或条件、设施和控制。该信息可以以工艺流程图的形式呈现，该流程图显示了成品医疗器材的生产、控制、组装、最终产品测试和包装的概述。

．应包括对灭菌方法的简要总结。

7.备註

．B等级产品仅须提供临床前研究，风险评估仅须提供风险分析及其结果。

．C等级产品如属于植入式器材、新进器材、含有新物质且与病患直接接触之器材等，须提供临床试验证据。需检附生物性评估报告。风险评估要求包含完整的风险分析、风险评估及减少风险措施。

．D等级产品均须提供临床试验证据。检附过去有关产品使用、安全、效能之公开报告的参考目录。风险评估要求包含完整的风险分析、风险评估及减少风险措施。

．文件和标籤应以英文提供。

． CMDR 认证有效期为 5 年，必须在初始批准后每五年更新一次，可以在到期前90天提交展延。

标籤

1.应根据特定的医疗器材及预期用途，按以下形式放置在适当位置：

．在适当的情况下，应在医疗器材本身上提供识别、安全使用医疗器材所需的信息。如果这不可行或不合适，部分或全部信息可能会出现在每个单元的包装(初级包装)和/或包装在一起的多个医疗器材的外包装上(二级包装)。

．如果每个单元的单独包装不可行或不合适，则应在使用说明 (IFU) 中列出信息(例如传单、包装插页、手册或其他提供的介质。)

．如果产品所有者向单个用户和/或位置提供多个医疗设备，则仅向他们提供一份使用说明的副本可能就足够且适当。在这些情况下，医疗器材用户应有权取得更多副本。

2. 标籤的媒介、格式、内容、可读性和位置应适合特定的医疗器材、预期用途以及预期用户的技术知识、经验、教育或培训。特别是，使用说明应以预期用户易于理解的语言编写，并在适当时辅以图纸和图表。一些医疗设备可能需要为医疗保健专业人员和非专业人士提供单独的信息。

3. 如果在没有任何此类说明的情况下可以按照产品所有者的意图安全使用，则可能不需要使用说明 (IFU)，或者可以将其用于低风险或中等风险的医疗设备。

4. 所有标籤的纸质版本/硬拷贝应随附医疗器材。

5. 风险分析中识别出的任何残馀风险应在标籤中体现为禁忌症、注意事项或警告。

6. 鼓励使用国际公认的符号，前提是医疗器材安全不会因患者或用户缺乏理解而受到影响。符号的含义对医疗器材用户来说并不明显，例如：对于非专业用户或新引入的符号，应提供解释。

7. 标籤上的所有字符都应具有足够的尺寸和清晰的印刷。

8. 产品标籤应以英文和/或菲律宾文书写。

9. 标籤与包装背景的颜色对比，设计不得掩盖信息。

10. 对于医疗器材软件，用户说明应以电子数据存储设备(如光盘、数字视频光盘或 USB 闪存驱动器/或其他媒体)形式提供。

11. 对于可从互联网下载的信息，互联网网址应清楚地印在设备的物理标籤上，并以向用户突出其目的的方式显示。产品所有者应确保电子标籤的内容与随产品註册申请提交的纸质格式(如适用)一致。用户和/或其他相关方也可以根据要求访问 IFU 的纸质版本。

12. 标籤不得包含任何直接或间接表明该医疗器材在市场上的投放、医疗器材的使用或操作正在由卫生部 – 食品和药物管理局推广或认可的任何声明(或其任何组织机构)。

13.医疗器材包装上应标註的下列具体内容：

．产品名称、商品名称或品牌名称，以允许用户识别医疗器材。

．产品所有者的姓名、地址和联繫方式(例如电话号码和获取技术帮助的网址)。

．FDA-CDRRHR在各级包装上颁发的医疗器材通知号证明或医疗器材註册证号。

．进口商和/或分销商的名称和地址。除非无菌性和自身寿命受到影响，否则所有级别的包装都是强制性的。

．用户识别医疗器材的足够详细信息。

．批号、批号或序列号(如适用)。

．到期日期至少以年和月表示(例如 2020 年 11 月)。

．特殊储存/容器、处理条件和/或储存条件。

．製造日期至少以年和月表示。

．验证医疗器材是否正确安装以及是否能够正确和安全运行所需的信息，包括性质的详细信息。预防性和定期维护的频率，任何质量控制、消耗性组件的更换和校准所需的校准确保医疗设备在其预期寿命内正常安全运行(如果适用)

．产品所有者预期的性能，以及相关的任何不良副作用。

．医疗器材可以使用之前所需的任何进一步处理或处理的详细信息(例如，灭菌、最终组装、校准、试剂和/或控製材料的製备等)。

．无菌医疗器材的标示和灭菌方法(例如：无菌加工技术灭菌；使用环氧乙烷灭菌；使用辐照灭菌和/或使用蒸汽或乾热灭菌)；有关如果无菌包装损坏该怎麽办的信息；以及重新灭菌的说明(如果适用)。

．产品所有者指定的一次性医疗器材标示。

．可重複使用的医疗器材的标示，允许重複使用的适当过程的信息，包括清洁、消毒、包装，以及适当的再消毒方法和重複使用次数的任何限制。

．医疗器材使用前的灭菌要求和清洗、灭菌工艺说明。

．应当註明翻新医疗器材的标示和翻新日期。

．定制医疗器材的标示和由合格从业者使用的声明。

．如果医疗器材旨在用于临床调查，或者对于 IVD 医疗器材，则需表明仅用于性能评估。

．如果医疗器材旨在仅用于研究和仅用于展示或演示目的，则应标註：不得用于人体。

．如果医疗器材仅供研究使用，则必须标明仅供研究使用。

．与植入可植入医疗器材有关的特殊风险。

．如果医疗器材为医疗目的发射辐射，应在其性质、类型和适当情况下详细说明该辐射的强度和分佈。辐射源将产生的医疗器材特定部分(例如 X 射线管)上的辐射符号也应标明。

．有关在特定调查、评估、治疗或使用过程中合理可预见的医疗设备存在所造成的相互干扰风险的信息(例如来自其他设备的电磁干扰)。

．如果医疗器材要与其他医疗器材或设备或专用软件一起安装或连接，以便按其预期用途的要求运行，其特徵的足够详细信息以识别正确的医疗器材或设备使用以获得安全的组合。

．体外诊断医疗器材应标註体外诊断。

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.

cdrrhr@fda.gov.ph

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.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2021/03/09-Feb-2021-FDA-Citizen_s-Charter-CDRRHR_CPR_02-February-2021.pdf

https://www.fda.gov.ph/downloadables/

HLF-ph-45

HLF-ph-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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?