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