Authorization of Medical Devices based on the ASEAN Harmonized Technical Requirements

The fast evolution of medical technology and the essential role of medical devices in the health care delivery system have highlighted the importance of ensuring the safety and effectiveness of these devices through regulation while facilitating trade among the ten member states of the Association of Southeast Asian Nations (ASEAN). Structured and regionally accepted technical requirements were developed through the ASEAN Consultative Committee on Standards and Quality — Medical Device Product Working Group (ACCSQ-MDPWG). The development of the common submission dossier template (CSDT) was a ‘combined effort of the ASEAN member states taking into consideration the global technical requirements developed by the Global Harmonization Task Force. The CSDT is a set of technical requirements for the registration of the medical device products agreed upon by the ten ASEAN member countries. The Philippines is committed to align its regulatory guidelines with this set of technical requirements, thus the issuance of this Administrative Order.

Procedural Guidelines:

 A. Initial

1. All applications with deficiencies shall be given a one-time compliance period of a maximum of 90 calendar days. If the deficiencies were not complied during the compliance period, the application shall be considered disapproved. However, the applicant may opt to submit a reapplication within 60 calendar days after the disapproval. If no compliance is received within the set compliance period, the application shall be automatically considered disapproved.

2. Product labels of the medical devices with issued CMDR or CMDN shall have the following national labeling requirements prior to sale and distribution

a. Name and address of the importer

b. Name and address of the distributor (if exclusive distributor)

c. CMDN number or CMDR number.

3. Documentary Requirements

a. The list of requirements for the Notification of Class A medical devices & Registration of Classes B, C and D medical devices are as follows (attached as Annexes):

a.1 Annex A — Legal Requirements for Application for the Notification of Medical Devices under Class A and Registration of Medical Devices under Classes B, C and D

a.2 Annex B — Technical Requirements for Application for the Notification of Medical Devices under Class A

a.3 Annex C — Technical Requirements for the Initial Registration of Medical Devices under Class B in Accordance with the CSDT Template

a.4 Annex D — Technical Requirements for the Initial Registration of Medical Devices under Class C in Accordance with the CSDT Template

a.5 Annex E — Technical Requirements for the Initial Registration of Medical Devices under Class D in Accordance with the CSDT Template

b. The CDRRH reserves the right to ask for additional documents not indicated in this order that may arise based on the submitted compliance documents

4. The application shall be evaluated within 180 days upon filing of the applications. All applications that do not comply with, the technical requirements shall be notified through a letter and shall be given a one-time chance to correct the deficiencies within 90 days. If the applicant still fails to comply with the requirements, he/she will be given a chance to re-apply, with a corresponding fee, and to submit the complete compliance documents within sixty (60) days. Failure to comply with the required documentation within the given period shall be a ground for disapproval of the application.

B. Renewal:

1. The filing for the renewal of the certificates of registration or notification shall be accepted within 90 calendar days prior to the expiry date of the CMDR or CMDN.

2. Applications for renewal of certificates of registration or notification filed after the validity date shall be fined with the corresponding penalty in accordance with the existing rules and regulations on fees and charges.

3. An application for renewal of CMDR filed after 120 calendar days after its expiration shall not be accepted and shall be considered an initial application. The distribution and sale of that medical device shall automatically stop until such time that the certification of product registration have been approved. The applicant can opt, however, to request the retention of the product registration/notification number.

4. The application for renewal shall be evaluated within 30 days upon filing of the application. All applications that do not comply with the technical requirements shall be notified through a letter and shall be given a one-time chance to correct the deficiencies within 30 days.

5. The requirements for the renewal are attached as Annex F, requirements for the renewal of Notification/Registration of Medical Devices for all classifications.

C. Medical Device Listing

1. The filing of application for Medical Device Listing should be made prior to the importation of the medical devices.

2. The list of requirements for Medical Device Listing are attached as Annex G, Requirements for the Application of Medical Device Listing.
 

Phases of Implementation:

This A0 shall cover initially all registrable products listed in FDA Memorandum Circular No. 2014-005: “Updated List of Medical Devices required to be registered prior to sale, distribution and use” and its amendments; the Notification of all class A medical devices; and the Medical Device Listing. The CDRRHR shall release the list of medical devices per classification based on the classification set forth in the ASEAN Medical Device Directive. The requirement of registration for all medical devices not indicated in the list of registrable medical devices shall be implemented in phases. The schedule of implementation shall be issued in separate memoranda.

The phases are listed as follows:

1. Phase 1: Notification of Class B, C and D that are non-registrable medical devices based on FDA Memorandum Circular No. 2014-005.

2. Phase 2: Registration of Class D (Notification of Class D shall cease during this phase)

3. Phase 3: Registration of Class B and Class C (Notification of classes B and C shall cease during this phase)