Draft Document for IVD Compliance
In preparation for full AMDD compliance for IVDs, PFDA has released a draft document detailing the general workflow for the initial registration and renewal applications for IVDs, alongside a stepwise transition to complete conformance with AMDD.
Risk Classification of IVDs
PFDA has adopted the definition of IVD terminologies from AMDD. The risk classification parallels that of general medical devices, categorized as Class A-D, reflecting increasing individual and public health risk based on Annex 3 of AMDD.
The applicant is responsible for the risk classification; however, the Center for Device Regulation, Radiation Health and Research (CDRRHR) will verify and reclassify the product when necessary.
IVD Authorization
The following certificates will be issued for IVD applications:
- CIVDL - Certificate of In Vitro Device Listing
- CIVDN - Certificate of In-Vitro Device Notification
- CIVDR - Certificate of In-Vitro Device Registration
Phases of Implementation
The regulation will be implemented in two phases:
-
Phase 1: Notification of All IVDs
During this phase, all IVDs, irrespective of risk class, shall be registered under PFDA. The list of registrable devices will draw from the PFDA list. Implementation occurs 6 months after the Administrative Order's effectivity (post draft signing). -
Phase 2: Registration of Class B-D Devices
All class B-D devices must obtain a CIVDR prior to marketing or require Full CSDT alongside performance validation. The application process will follow outlined protocols. -
Phase 2 implementation will be announced in a separate circular.
NRL will maintain communication with the FDA regarding the capability to conduct performance evaluations of IVDs. Applications should be sent to the NRL, FDA Common Services Laboratory, or other FDA-approved labs for performance evaluation, even if there are issues with documentation and technical reviews.
Other Salient Points of the Draft Regulation
- PFDA will release a separate circular outlining the specifics regarding application processing and evaluation.
- All submitted documents must be in English or accompanied by an English translation.
- CDRRHR reserves the right to request additional documentation beyond what is listed in the regulation.
- Performance evaluation is waived for WHO pre-qualified IVDs; PFDA will review documents to ensure compliance with NRL standards.
- CIVDR or CIVDN Renewal: Automatic renewal is feasible if the application is submitted before the expiration date, the necessary fees are paid, and a sworn statement confirming no changes to specifications, labeling, and components is provided.