Medical Device Registration in

Philippines

Ministry of Health

Department of Health (Philippines)

Regulatory Authority

Food and Drug Administration, Philippines

Medical Device Regulation

Administrative Order 2018-0002

Official Language

Filipino, English

Classification

Class A, B, C, D

Registration Process

  • Determine the device classification
  • Appoint an Authorized Representative.
  • Prepare the Technical documentation and submit to FDA.
  • 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.

Documents Required

  • QMS certification
  • Free Sale Certificate from Country of Origin
  • Device description, features, indications
  • Technical Documents
  • Clinical Studies
  • Shelf Life and Biocompatibility
  • Label, IFUs and User Manual
  • Risk Analysis
  • Manufacturing Process

Applicable QMS

ISO 13485:2016

Registration Timeline

6-9 months

Authorized Representative

Yes

License Validity

5 years

Looking for Medical Device Registration? Setup a meeting!

8 + 7 =