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Philippines FDA Publishes Revised Draft of New IVD Regulations
Published on: September 14th, 2022
On December 2, the Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD regulations along with a definitive timeline for the implementation. This latest version includes some significant changes from the most previous version published in February of this year (as covered by an Asia Actual article available here).
Some of the main points include:
- Sub-categories of IVD devices are defined with varying regulatory requirements
- IVDs for commercial distribution – refers to IVDs that are intended for sale to clinical laboratories, hospitals, pharmacies and/or medical device retailers to be used for or by patients for in vitro diagnostic purposes
- Government Internationally Procured IVDs
- Donated Brand New IVDs
- Research Use Only (RUO) IVDs [side note from Roche: by definition, an RUO cannot be an IVD]
- IVDs that are Not Intended for Commercial Distribution
- Imported IVDs for Personal Use
- Risk Class A products will require Registration instead of Notification.
- The requirements for Class A registrations is the same as the previously-published draft for Class A notifications. According to the FDA, the change in terminology is based on the recommendation from their Legal Department.
- There is a provision for automatic renewal as long as certain conditions are met.
- Annex I – Requirements for Application for CIVDL for Research Use Only (RUO) IVDs
- Must include labeling stating that the product is RUO only [not officially written in the draft but noted by the FDA during the public hearing]
- Certificate of IVD registration or any equivalent document: The FDA will consider the request to remove this requirement during the meeting based on the justification that no such certification is available for RUOs.
Implementation Timeline for New IVD Regulations
The FDA also outlined the intended implementation timeline for the new IVD regulations as shown below. The Administrative Order covering the new IVD regulations will be published in Q4 of 2022 and will take effect 15 days after the publication date. Then Class A IVD devices will have a 2 year grace period to obtain a Certificate of IVD Notification (CIVDN). Class B, C and D devices will have an additional 1 year grace period obtaining a Certificate of IVD Registration (CIVDR). Exceptions to the grace-period include test kits for Covid-19 and Monkey Pox along with the existing list of Notified devices (see the list below) that already require a IVDR under the existing medical device rules.
List of Notified IVD devices that currently require CIVDRs:
- HIV, HBV, HCV and syphilis
- Drug screening test
- Blood Typing Sera
- Anti-human Globulin Reagents
- Potentiators such as enzyme, LISS and albumin
- Column Agglutination test for crossmatching & blood typing
- Pregnancy test kits/reagents
- Leptospirosis test kits/reagent
More Information to Come from the Philippines FDA
Guidelines on the endorsement of applications and the responsibilities of the applicant and of the NRL regarding the performance validation and/or technical review of IVDs will be covered by a separate FDA Circular still to come.
COVID and Monkeypox reagents to become registrable
Start of Transition Phase
Start of Voluntary Registration
End of Transition Phase
Philippines Draft IVD Regulations Overview
Applications are first subject to pre-submission review at which device classification, grouping and completeness of documentation will be verified by the Center for Device Regulation, Radiation Health and Research (CDRRHR) while the technical data requirements are as per ASEAN MDD Common Submission Dossier Template (CSDT). Once approved, the product will receive a CIVDN or a CIVDR number that must be included on the labeling. All documents will need to be submitted in English.
Class A CIVDNs and CIVDRs will be valid for 5 years while class B, C, and D IVDs registered under the notification process during the transition will be valid for 2 years. At the end of the 2 years, the class B, C, and D IVDs will need to renew and obtain a CIVDR which will then be valid for 5 years. This follows the implementation phases of the new medical device regulations.
For more information on the draft IVD regulations released in February of 2022, please see our article on the topic here.
Grow With Us
Please contact us if you have questions regarding the new regulations and/or are interested in registering your product in the Philippines. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.