Medical Devices Post-Market Surveillance in the Philippines

The Philippines’ Food and Drug Administration (PFDA) is the local authority responsible for the medical devices in the Philippines and requires all medical device manufacturers and distributors (whether importer, exporter or wholesaler) to undertake post-market surveillance (PMS) and have a PMS plan. The Philippines FDA has chosen to adopt the Post-Market Alert System (PMAS) for Defective Devices of the ASEAN Medical Device Directive (AMDD). Please read on to understand how post-market surveillance for medical devices is implemented in the Philippines.

Why Get Medical Devices PMS in the Philippines

Registering your IVD device in Indonesia offers numerous advantages for your business:

Our Medical Device Post Market Surveillance Services

Report Management

Support for your mandatory reporting of Adverse Effects and Field Safety Corrective Actions

Documentation

Identify requirements in medical device directives, standards, and guidance documents

Data Evaluation

Evaluate your PMS data to ensure that existing processes and outputs are fully compliant

Maintain Compliance

Monitor and report on any regulatory changes to ensure ongoing compliance

Medical Device PMS Requirements in the Philippines

In accordance with Annex 5 of the AMDD, the following is required as part of a PMAS in the Philippines:

Importation and/or distribution records

Complaint records

Adverse Event (AE) reporting criteria and reporting format

Field Safety Corrective Action (FSCA) reporting format

All medical device establishments, manufacturers, distributors, importers, exporters, wholesalers must have a Quality Management System (QMS) and relevant documentation in place. This is checked and audited by the Philippines FDA during its routine inspections. The QMS must include an established Risk Management Plan (RMP) and Standard Operating Procedures (SOPs) together with their related forms for Good Storage and Distribution, Complaint Handling, Product Recalls, Medical Device Disposal/Destruction.

IMPORTANT REMINDER

In the Philippines an importer is the Local Authorized Representative of Foreign Manufacturers please refer to our Registration of Medical Devices in the Philippines for clarification.

Medical Device PMS Requirements in the Philippines

In accordance with Annex 5 of the AMDD, the following is required as part of a PMAS in the Philippines:

Importation and/or distribution records Complaint records Adverse Event (AE) reporting criteria and reporting format Field Safety Corrective Action (FSCA) reporting format
All medical device establishments, manufacturers, distributors, importers, exporters, wholesalers must have a Quality Management System (QMS) and relevant documentation in place. This is checked and audited by the Philippines FDA during its routine inspections. The QMS must include an established Risk Management Plan (RMP) and Standard Operating Procedures (SOPs) together with their related forms for Good Storage and Distribution, Complaint Handling, Product Recalls, Medical Device Disposal/Destruction.

IMPORTANT REMINDER

In the Philippines an importer is the Local Authorized Representative of Foreign Manufacturers please refer to our Registration of Medical Devices in the Philippines for clarification.

Adverse Event reporting requirements in the Philippines

The following medical device associated AEs must be reported to the Philippines FDA
Adverse events Report within
Serious threat to public health: Immediately or not later than 48 hours 48 hours
Death 10 days
Serious deterioration in state of health 10 days
Possible death or serious injury if the adverse event were to recur 30 days
Medical Device Companies reporting Adverse Events will need to send their AE report via email to the Director of the Center for Device Regulation Radiation Health and Research (CDRRHR) and the Division Chief of Product Research and Standard Development Division (PRSDD). The FDA evaluator accepts reports from all distributors, manufacturers, owners, end-users of devices using the prescribed format (CDRRHR-PRSDD-Form 0.20). The FDA evaluator validates any adverse event (AE) which meets the three basic reporting criteria listed below:
  • An Adverse Event has occurred
  • The device is associated with the AE
  • The AE led to one of the following outcomes:
    • A serious threat to public health
    • Death of a patient, user or other person
    • No death or serious occurred but the event that might lead to death or serious injury of a patient user or other person if the event recurs.
As part of PMS for medical devices in the Philippines, the evaluator follows up with the reporting person for further information and processes valid reports using CDRRHR-PRSDD-Form 021. If the suspected medical device is registered, the evaluator issues Corrective and Preventive Action (CAPA) to the distributor, manufacturer, or owner about the adverse event/complaint and requires them to conduct corrective action and submit a report. This may lead to the possible issuing of an Advisory or an Advisory plus surveillance or recall of the suspected device.

Any adverse event occurring outside the Philippines do not qualify for reporting to the PFDA, unless the user is Filipino and the device is obtained from the Philippines, or it is otherwise requested. The country of occurrence should be stated.

Why Choose Andaman Medical for Your Medical Device Post-Market Surveillance in Philippines

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Contact us today to discuss how Andaman Medical can be your trusted partner for Medical Device Post Market Surveillance in the Philippines. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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