Philippines: FDA Publishes New Draft for IVD Regulations

ARQon
May 6, 2022
3 min read

In January 2022, the Philippines FDA published a new draft regulation on IVD market authorization. The draft was open for public review until 7 February 2022. Previously, very few IVD devices required a Certificate of Product Registration to be imported and sold into the Philippines market. With these updates, all IVD devices will be subjected to premarket notification and registration. Listed below are the notified IVD devices:

1. HIV, HBC, HVC and syphilis test

2. Drug screening test

3. Blood type sera

4. Anti-human globulin reagents

5. Potentiators such as enzyme, LISS and albumin

6. Column Agglutination test for crossmatching and blood typing

7. Pregnancy test kits 8. Leptospirosis test kits The new registration, notification and listing certificates for IVD are:

Certificate of In-Vitro Diagnostic Notification (CIVDN)
Certificate of In-Vitro Registration (CIVDR)
Certificate of In-Vitro Diagnostic Listing (CIVDL)

The new regulations were introduced in phases to ease into the new requirements. In the first phase:

All class A devices required a CIVDN
Notified Class B, C and D devices (as listed in FDA Circular No. 2014-005) required a CIVDR. Note that existing Certificates of Product Registration (CPR) issued under the previous regulations are still valid until their expiration date.

In the second phase, CIVDN will no longer be issued to Class B, C and D devices, and CIVDR issuance will be mandatory for all Class B, C and D IVDs. Important information about new administration

Notified medical devices will be re-classified according to AMDD risk classification
Class A CIVDN and Class B, C and D CIVDR will be valid for five years. However initial Class B, C and D CIVDN will only valid for two years
Applicants must submit the requirements found in the following Annexes:

Annex A - Legal Requirements for Application for the Notification of IVD under Class A and Registration of IVD under Class B, C and D
Annex B - Technical Requirements for Application for the Notification of IVD under Class A
Annex C - Technical Requirements for the Initial Registration of Class B, C, and D IVD. The summary list of requirements for the initial registration of Class B, C and D IVD can be found in Annex D
Annex E - Requirements for the Renewal of Notiﬁcation/Registration of I8VD for All Classiﬁcations
Annex F - Requirements for Application for the Certiﬁcate of IVD Listing

Reagents, reagent product, calibrator, control material, kit, instruments, apparatus, equipment or systems or software manufactured, sold or represented by manufacturers not for use in in-vitro diagnostic application and general laboratory use purposes are not classified as IVD.
Application for registration of IVD for class B, C and D shall be endorsed to the FDA Common Services Laboratory, NRL or other FDA accredited/recognized laboratory for performance evaluation, regardless if deficiencies were found during the document and technical review. Guidelines on the endorsement of application, responsibilities of the applicant and of the NRL regarding the performance evaluation of IVDs shall be covered by a separate FDA Circular.
IVDs that passed the World Health Organization (WHO) pre-qualification shall not undergo performance evaluation but will undergo document review by the FDA. However, the IVD shall conform to the standard criteria on parameters set by the NRL.
Automatic Renewal of CIVN/CIVDR when all the following conditions are fulfilled:
The application is filed before the expiration date of registration or notification
The prescribed renewal fee is paid upon filing of the application
A sworn statement indicating no change or variation whatsoever in the product is attached to the application
Selected IVDs that require post approval commitments to ensure their quality, safety and performance shall not be qualified for automatic renewal. Post approval commitments are indicated in the issued CIVDR or CIVDN. These PAC shall be submitted to FDA during application for renewal of CIVDR or CIVDN in addition to the regular requirements specified in Annex E.