Authorization of Medical Devices based on the ASEAN Harmonized Technical Requirements

The rapid advancement of medical technology and the growing importance of medical devices in healthcare have underscored the need for regulatory measures that ensure product safety and effectiveness while promoting trade across ASEAN member states. Through the ASEAN Consultative Committee on Standards and Quality – Medical Device Product Working Group (ACCSQ‑MDPWG), ASEAN developed harmonized technical requirements embodied in the Common Submission Dossier Template (CSDT). This template reflects global best practices established by the Global Harmonization Task Force. In alignment with these standards, the Philippines has issued this Administrative Order.

Procedural Guidelines

A. Initial Applications

1. Applicants with deficiencies will be granted a one‑time compliance period of up to 90 calendar days. Failure to comply will result in disapproval. Applicants may reapply within 60 days from disapproval. If no compliance is received within the prescribed period, the application will be automatically disapproved.

2. Medical device product labels for issued CMDN or CMDR certificates must include:

   • Name and address of the importer 

   • Name and address of the distributor (if an exclusive distributor) 

   • CMDN or CMDR number 

3. Documentary Requirements 

   a. Requirements for Notification (Class A) and Registration (Classes B, C, and D) are listed in the following annexes:

      • Annex A – Legal Requirements 

      • Annex B – Technical Requirements for Class A Notification 

      • Annex C – CSDT Technical Requirements for Class B Registration 

      • Annex D – CSDT Technical Requirements for Class C Registration 

      • Annex E – CSDT Technical Requirements for Class D Registration 

   b. CDRRH may request additional documents as necessary based on submitted information.

4. Applications will be evaluated within 180 days from filing. Deficient applications will be notified and provided a one‑time 90‑day correction period. Failure to comply requires re‑application (with fees) within 60 days. Non‑compliance will lead to disapproval.

B. Renewal Applications

1. Renewal filings must be submitted within 90 days prior to CMDR or CMDN expiration.

2. Late renewal filings will incur penalties according to applicable fees and charges.

3. Renewals filed more than 120 days after expiration will be treated as new applications. Distribution and sale must cease until approval is granted. Applicants may request retention of the original registration/notification number.

4. Renewal applications will be evaluated within 30 days. Deficiencies must be corrected within a one‑time 30‑day period.

5. Renewal requirements are listed in Annex F.

C. Medical Device Listing

1. Applications for medical device listing must be filed before importation.

2. Requirements for Medical Device Listing are provided in Annex G.

Phases of Implementation

This Administrative Order initially covers the following:

• Registrable products listed in FDA MC No. 2014‑005 and its amendments 

• Notification requirements for all Class A devices 

• Medical Device Listing 

CDRRHR will publish device classifications based on the ASEAN Medical Device Directive. Registration requirements for devices not included in the existing list will be implemented in phases through separate memoranda.

Phased implementation includes:

1. Phase 1 – Notification of Class B, C, and D devices that are non‑registrable under FDA MC No. 2014‑005 

2. Phase 2 – Registration of Class D devices (Class D Notification ends) 

3. Phase 3 – Registration of Class B and Class C devices (Notifications for these classes end)