Medical Device Registration in
Ministry of Health
Medical Device Regulation
Administrative Order 2018-0002
Class A, B, C, D
- 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.
- 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