Post-Market Surveillance of Medical Devices in the Philippines
The Philippines’ Food and Drug Administration (PFDA) is the local authority responsible for 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 is implemented in the Philippines.
What are the requirements for medical device PMS in the Philippines?
In accordance with Annex 5 of the AMDD, the following is required as part of a PMAS in the Philippines:
1.
Importation and/or distribution records
2.
Complaint records
3.
Adverse Event (AE) reporting criteria and reporting format
4.
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.
Please note: 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 | 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.
The evaluator follows up with the reporting person for further information and processes valid reports using CDRRHR-PRSDD-Form 021. If the suspected 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.
How Andaman Medical can help you with post-market surveillance in the Philippines
With 6 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including adverse event and FSCA mandatory reporting. Our local, in-house staff liaise with the Food and Drug Administration to help you maintain compliance once your medical device is placed on the market. Our services include:
- support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions
- identify requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
- evaluate your PMS data to ensure that existing processes and outputs are fully compliant
- monitor and report on any regulatory changes to ensure ongoing compliance