Regulatory Authority

 Food and Drug Administration (FDA) headed by the Department of Health


Classification

Class A (low risk), Class B, Class C, Class D (high risk)


Quality System

ISO 13485:2016


Procedure

Medical devices manufacturers may not import, export, manufacture, distribute or market their products in the Philippines, unless they are notified or registered with the FDA, depending on the device risk classification.

Class A devices must be notified and consequently the Regulatory Authority issues the Certificate of Medical Device Notification (CMDN).

Class B, C and D devices must be registered with FDA, following which the Certificate of Medical Device Registration (CMDR) will be issued.


Applicant

Foreign manufacturers shall appoint an Authorized Representative.


Timeframes and fees

Fees depend on the device risk class. Notification and registration timeframes vary from 3 to 6 months.


Validity

The ISO 13485: 2016 certification must be renewed annually. The CMDN and CMDR certifications are valid for 5 years.


Labeling and documentation language

Documentation and labeling shall be provided in English.


Useful Information

In order to comply with the ASEAN Directive on medical devices, on January 26, 2018 the Regulatory Authority issued the Administrative Order 2018-0002 changing the registration requirements for medical devices.

The final implementation will be effective as of April 1, 2019, therefore Manufacturers and Authorized Representatives have 12 months to comply with the updated requirements.