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IVD Device Registration in The Philippines
April 2022 Update: The Philippines FDA has released draft IVD Guidance and more information can be found here along with the implementation schedule here.
Philippines IVD product registration is managed by the Center for Device Regulation, Radiological Health and Research (CDRRHR) of the Food and Drug Administration (FDA) within the Department of Health (DOH).
Current Registration Requirements
Most IVD devices will require a Certificate of Product Registration. Proof of regulatory approval in the country of origin is a required, but reference country approval (from the US, EU, Canada, Japan or Australia) may be used instead. Certain documents such as the Free Sale Certificate, ISO certificate and Foreign Agency Agreement must be authenticated by the territorial Philippine Consulate. Obtaining authentication can take 4 to 12 weeks and is often the bottleneck in the regulatory submission. The initial application for PRC takes 180 days to process. FDA processing fees total US$35. Initial PRC are valid for 1 year. Reregistration certificates are then valid for 5 years and can be processed in 60 to 90 days with no variation in application data. Otherwise the reregistration process will take 180 days. The FDA fee for registration is US$115.
IVD devices that do not require a CIVDR, can be imported by a company with a Letter to Operate (LTO). The application processing requires 2 to 4 weeks with FDA fees of $12.
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
Applications must be submitted by and subsequent CIVDR are held by a licensed importer, distributor or manufacturer. The License To Operate of the importer, distributor or manufacturer must be up-dated with the foreign manufacturing source data. The amendment process to the LTO takes 4 to 8 weeks and carries government fees of US$90.
Quality systems conformity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.
PHILIPPINES’ DRAFT IVD REGULATIONS OVERVIEW
Originally released in February 2022, the draft IVD regulations outline the new requirements for registering all IVD products. 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). 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 include on the labeling. All documents will need to be submitted in English.
OTHER IMPORTANT ASPECTS OF THE IMPLEMENTATION PLAN INCLUDE:
- Notified medical devices will be re-classified according to AMDD risk classification
- Validity of Class A CIVDN & Class B, C, and D CIVDR will be 5 years
- Validity of initial Class B, C, and D CIVDN will be 2 years
- Government processing fee for initial CIVDN/CIVDR application is PhP7,500 (about US$150); and PHP5,000 (US$100) for renewal applications (pricing is subject to future adjustments)
- All Medical Devices and IVD that are not included in the scope of initial implementation shall be considered non-regulated products; importers License to Operate (LTO) may be provided for customs clearance in lieu of a COE.
- Administrative data requirements include:
- Letter of authorization copy with Notarized Declaration Letter of Authenticity
- ISO 13485 copy with Notarized Declaration Letter of Authenticity
- Requirement for Certificate of Free Sales (CFS) has been eliminated
- Copy of registration from country of origin with Notarized Declaration Letter of Authenticity
- Color picture of the device from all sides
What is the Validity of New CIVDNs and CIVDRsClass 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.
What is the Grouping Guidance for IVDs Under the new Regulations
Per point 4, it is expected that grouping products together into one application and certificate (CIVDN or CIVDR) will continue to be difficult strict as is the case for medical devices. While application fees remain lower than other markets in the region, the Philippines FDA does often require separated certificates for variations in brand name, materials, etc. which require separate fees even if one CSDT application is submitted.
What Document Are Required for IVD Device Registration in the Philippines?
Document requirements are expected to follow ASEAN AMDD guidance and more information on specific draft requirements can be found in the following Annexes provided with the draft IVD guidance:
- 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 IVD for All Classifications
- Annex F – Requirements for Application for the Certificate of IVD Listing
What Are the In-Country Testing Requirements for IVD Registration in the Philippines?
The plan is to have all IVD Registration applications to have performance test data generated by locally, approved test facilities such as the Research Institute of Tropical Medicine (RITM). According to point 9 of the draft IVD guidance, Class B, C, and D IVD applications will need to be endorsed by a FDA Common Services Laboratory, national research laboratory (NRL), or other FDA accredited/recognized laboratory for performance evaluation. Additional guidance on the performance evaluation requirements of IVDs will be covered by a separate FDA Circular. In-country testing fees will be separate from application fees and will be provided by the RITM or another compliant laboratory.
Come Grow With US
Contact Asia Actual for assistance with your IVD device registation in the Philippines or to confirm the cost and time lines that apply to your specific devices of interest. Asia Actual has experienced, top level consultants in the Philippines to manage the application process.
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