Philippines Medical Device Regulations QA
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HLF-ph-10
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：
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
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：
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
假如需要辦理，請問菲律賓有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
NDL
YKC
HLF-ph-30
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?
Everhine RD：
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
假如需要辦理指派菲律賓公司擔任營業代理人，請問菲律賓有專業服務公司可以協助？
Evershine RD：
VMed Medical
Asya Medika
https://www.asyamedika.com.ph/
HLF-ph-40
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：
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
請問在菲律賓有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
TÜV
Freyr
https://foodsupplements.freyrsolutions.com/
HLF-ph-50
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：
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
請問在菲律賓有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
Evershine RD：
TÜV
Freyr
https://foodsupplements.freyrsolutions.com/
HLF-ph-60
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：
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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
菲律賓醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
TÜV
SGS
HLF-ph-77
請問在菲律賓有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？
Evershine RD：
TÜV
SGS
HLF-ph-80
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：
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
請問在菲律賓有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？
Evershine RD：
Victoriano Tiu & Aureus
https://victorianotiuaureus.com/
A&T Law
Contact Us
Manila Evershine BPO Service Limited Corp.
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Contact by Viber or Skype in working hours of Philippines time zone.
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For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4mnl@evershinecpa.com
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Tel No.: +886-2-27170515 ext. 105
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(version: 2024/07)
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