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:
HIV, HBC, HVC, and syphilis test
Drug screening test
Blood type sera
Anti-human globulin reagents
Potentiators such as enzymes, LISS, and albumin
Column Agglutination test for crossmatching and blood typing
Pregnancy test kits
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 registration was 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. Noted 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. Phase 1 shall be implemented six months after the effectivity of this Order. The schedule of implementation of phase 2 shall be issued in a separate FDA Circular.
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