Medical Device Registration in the Philippines

Medical Device Registration in the PhilippinesIn June 2013, the National Health Insurance Act was signed into law, making national healthcare coverage available to all Filipinos. Currently, more than 80% of Filipinos are covered under the scheme. However, the coverage provided is very limited. In late September 2014, the Philippines released draft device registration document requirements based on the ASEAN Medical Device Directive (AMDD).

With the help of Pacific Bridge Medical’s registration experts, your medical device can be approved quickly in the Philippines. We will help you achieve compliance with Philippine regulations so you can import and register your medical devices in the Philippines as soon as possible.

To find out more information on the proposed outline for medical device registration in the Philippines, click on the questions below.

Which regulatory bodies in the Philippine government are responsible for medical device registration in the Philippines?

The Philippines’ Food and Drug Administration (FDA), formerly the Bureau of Food and Drugs (BFAD), was created under the Department of Health to license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices, and household hazardous waste in the Philippines.

In the Philippines, are medical devices required to be registered before they can be sold?

Yes, medical devices require registration before being sold in the Philippines.

What are the different regulatory classifications for medical devices?

The draft device registration requirements released in September 2014 better align the Philippines with ASEAN’s Common Submission Dossier Template (CSDT). In the near future, the classification rules shall be based on the ASEAN Medical Device Directive (AMDD).

  1. CLASS A – Low risk (e.g. bandages)
  2. CLASS B – Moderate risk
  3. CLASS C – Moderate/high risk
  4. CLASS D – High risk (implantable defibrillators)

What does the registration pathway look like for each regulatory classification?

According to the draft regulations from September 2014,

  • CLASS A – Medical devices under this classification must apply for a Certificate of Medical Device Notification (CMDN).
    • Submit the application for notification.
    • The Philippines FDA reviews the application.
    • If approved, a Notification Number will be issued to the device.
    • If all the documents are accurate, a notification number will be issued to the device and the applicant is approved for the CMDN.
  • Class B to D – Medical devices under this classification must apply for a Certificate of Medical Device Registration (CMDR).
    • Prepare dossier.
    • Submit the application dossier (CSDT format) for registration.
    • The Philippines FDA reviews the application dossier and supporting documents.
    • If further information is requested, the applicant must submit answers addressing the supplementary questions.
    • If all the documents are accurate, the applicant is approved for a CMDR.

Timeline – 3-6 months for approval.

What are the document requirements for registration for each regulatory classification?

CLASS A (CMDN Application)

  • Documents required for the CMDN application:
    1. Notarized e-copy affidavit
    2. Notarized application form
    3. Photocopy of the valid License to Operate in the Philippines issued by the FDA
    4. Proof of payment or order of payment
    5. For distributors, the Certificate of Agreement between the Manufacturer and Distributor regarding the device; for imported medical devices, the Philippine consulate must appropriately authenticate the Certificate
    6. Government certificate attesting to the status of the Manufacturer ‘s competency and reliability of the personnel and facilities or Quality Systems Certificate of approval or compliance certificate with ISO 9000 series or ISO 13485
    7. For imported medical devices, Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency/accredited notified body in the country of origin and duly authenticated by the territorial Philippine Consulate. A certificate of free sale shall not be accepted
    8. Representative sample or commercial presentation of the product, when needed, and a color picture of the device
  • Technical requirements in accordance with the CSDT of the AMDD:
    1. Device description consisting of the following:
      • Intended use
      • Instruction for use
      • List of all raw materials
      • Technical specification of the finished product
      • List of reference codes, sizes, colors, models and variance, whichever is applicable.
    2. Sterilization method and sterility test done on the device
    3. Certificate of conformity to the aspect of manufacturer relating to metrology for devices with measuring functions
    4. Declaration of conformity (self-declaration by the manufacturer) with product standards, if applicable
    5. Sample of labels on the device and its packaging and other labeling materials to be used for the device that includes user’s or instruction manuals
    6. Stability studies of the product to justify claimed shelf life, if applicable

CLASS B (CMDR Application)

  • National Legal Requirements:
    1. Notarized e-copy affidavit
    2. Notarized application form
    3. Photocopy of the valid License to Operate in the Philippines issued by FDA
    4. Proof of payment or order of payment
    5. For distributors, the Certificate of Agreement between the Manufacturer and Distributor regarding the device; for imported medical devices, the Philippine consulate must appropriately authenticate the Certificate
    6. Quality Systems Certificate of Approval on Manufacturing, or compliance certificate with ISO 9000 series or ISO 13485; for imported medical device, the Certificate shall be duly authenticated by the territorial Philippine Consulate
    7. For imported medical devices, a Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency/accredited notified body in the country of origin and duly authenticated by the territorial Philippine Consulate
    8. Representative sample or commercial presentation of the product, when needed, and colored picture of the device
  • Technical requirements in accordance with the CSDT of the AMDD:
    1. Executive summary
    2. Relevant essential principles and method/s used to demonstrate conformity, if applicable
    3. Device description (including intended use, warnings, precautions, potential adverse effects, etc)
    4. Summary of design verification and validation documents (e.g. declaration certificates, medical device labeling samples, risk analysis, etc.)
  • Physical Manufacturer information:
    1. Manufacturing process, including quality assurance measures
    2. A brief summary of the sterilization method

CLASS C (CMDR Application)

  • All of the requirements of class B, except for pre-clinical studies
  • Risk assessment consisting of risk analysis, evaluation and reduction measures
  • Clinical evidence for the following:
    1. Implantable devices
    2. Newly introduced devices
    3. Devices incorporating new materials coming into contact with the patient
    4. Existing materials applied in a body part not previously exposed to that material, and for which no prior chemical experience exists
    5. An existing device that is modified and the modification might affect safety and effectiveness
    6. Software validation studies, if applicable
    7. Biological evaluation, if applicable

CLASS D (CMDR Application)

  • All requirements for class C, except clinical evidence items
  • List of countries where the device has been sold
  • A summary of all studies on which the manufacturer relies to ensure that the device meets the safety and effectiveness
  • A bibliography of all published reports dealing with the use, safety, and effectiveness of the device
  • Objective evidence (study) on biological safety of the device, if the device contains animal or human tissue or their derivatives

Is local testing (type testing/sample testing) required for registration?

Local testing is generally not a requirement for medical device registration in the Philippines.

When are clinical studies required for registration?

Clinical data is generally required for the following devices:

  1. Implantable devices
  2. Newly introduced devices
  3. Devices incorporating new materials coming into contact with the patient.
  4. Existing materials applied in a body part not previously exposed to that material, and for which no prior chemical experience exists.
  5. An existing device that is modified and the modification might affect safety and effectiveness.

Foreign clinical data is usually accepted.

Is approval in the Country of Origin required for registration?

Yes, approval in the country of origin is a requirement for registration.

Contact us today to speak with one of our experts in Philippine regulatory compliance.

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