Updated Draft Guidelines for IVD Authorization
In preparation for the full AMDD compliance for IVDs, PFDA has released a draft document which details the general workflow of the initial registration and renewal applications for IVDs as well as the stepwise transition to full conformance to AMDD.
Risk Classification of IVDs
PFDA has adopted the definition of IVD terminologies from AMDD. The risk classification is similar for general medical devices, Class A-D in order of increasing individual and public health risk based on Annex 3 of AMDD.
The applicant will be responsible for the risk classification, but the Center for Device Regulation, Radiation Health and Research (CDRRHR) shall verify and reclassify the product whenever necessary.
IVD Authorization
These are the types of certificates to be issued for IVD applications. More information in the succeeding sections:
- - 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 parts:
- - Phase 1- Notification of All IVDs- During this period, all IVDs regardless of risk class shall be notified under PFDA. The list of registrable devices will be based on PFDA list.
- Class B-D devices should also have CIVDN prior to marketing but CIVDN for these devices I valid for only 2 years. After which, the concerned party must apply for a CIVDR. Full submission of the ASEAN Common Submission Dossier (CSDT) is required for this, but performance validation is not necessary.
- Phase 1 implementation is 6 months after effectivity of Administrative Order (after draft is signed)
- - Phase 2- Registration of class B-D Devices
- All class B-D devices shall have CIVDR prior to marketing
- Full CSDT is required together with performance validation.
- The following process shall be followed during the application
- Phase 2 implementation will be released in a separate circular
- PFDA will issue an updated list of IVDs that need to be tested and checked by National Reference Laboratories (NRLs) before they can be registered. NRL will notify and keep the FDA up to date on its ability to do performance evaluations of IVD.
- Applications will be sent to the NRL, FDA Common Services Laboratory or other FDA-approved laboratory for a performance evaluation, even if there were problems with the documents and technical review. PFDA will issue in a separate FDA Circular regarding the details as to how to get an application endorsement, what the applicant and the NRL should do or are responsible for when it comes to testing IVDs.
- The NRL performance evaluation is separate from the validity of the CVDR.
Types of IVD Authorization
|
Authorization |
Scope |
Validity |
Fees |
Requirements2 |
|
Certificate of IVD Listing (CIVDL) |
IVDs not for sale and intended for clinical study, educational purposes exhibit or personal use |
During Importation of product (1-time) |
Php 5103 |
Annex F |
|
Certificate of IVD Notification (CIVDN) |
|
|
|
|
|
Certificate of IVD Registration |
Class B, C and D IVDs |
5 years and shall be renewed every 5 years
|
|
|
Notes:
1: Applicable during Phase 1 Implementation
2: Refer to draft IVD document (PFDA IVD Draft)
3: Based on fees on other device listing applications. Might change after approval
Other Salient points of the draft regulation:
- - PFDA will issue a separate circular for the specifics of the application receiving processing and evaluation.
- - All documents submitted must be English or accompanied by an English translation.
- - CDRRHR has the right to request additional documents not listed in the regulation.
- - Performance evaluation is not required for World Health Organization (WHO) pre-qualified IVDs. PFDA will still, however, review the documents and ensure that the standards set by the NRL are met.
- - CIVDR or CIVDN Renewal- Automatic renewal is possible provided that the application is filed before the expiry date, the renewal fee is paid upon filing of application and a sworn statement that there was no change or variation in the specifications, labeling and components of the product.
- CIVDRs or CIVDNs with indicated post approval commitments (PAC) during issuance of the certificate cannot apply for automatic renewal. PAC are issued to make sure that the product is safe and effective and must be submitted during the renewal application in addition to the list of requirements in Annex E of the regulation.
Draft: List of Registrable IVDs and Updated Technical Requirements for COVID-19 Test Kit Regulation
This regulation is issued to support the previous draft IVD regulation and to update the technical requirements for COVID-19 Test Kits regulation. The Product Research and Standards Development Division (PRSDD) will be receiving comments to this draft until 04 March 2022.
List of Registrable IVDs
In accordance with the capabilities of the FDA-CSL and NRLs, a detailed list of the various registrable IVDs was provided. There are 4 NRLs in addition to the FDA-CSL.
- - FDA-CSL will oversee evaluating qualitative immunochromatographic assay Pregnancy Test Kits using urine specimen.
- - NRL1: San Lazaro Hospital – STD AIDS Cooperative Central Laboratory will be responsible for all the evaluation of HIV, HBV, Hepatitis Markers, HCV, Syphilis and CD4 test systems.
- - NRL2: East Avenue Medical Center is designated to test rapid test kits and assay reagents for
- Shabu (Methamphetamine)
- Marijuana (THC)
- Amphetamine
- Cocaine/Benzoylecgonine
- Ecstasy (MDMA)
- Opiates (Morphine/Codeine)
- Benzodiazepine (Nordiazepam/Oxazepam).
Each of these drug analytes have its own designated cut-off values.
- - NRL3: National Kidney and Transplant Institute shall take charge of the performance evaluation of:
- anti-A reagents (16 products)
- anti-B reagents (8 products)
- anti-D/Rh reagents (21 products)
- known cells or reverse cells (6 products)
- anti-human globulin (AHG) reagents (11 products)
- potentiators (11 products)
- antibody screen agents (11 products)
- antibody identification reagents (9 products)
- phenotyping reagents (32 products)
- miscellaneous reagents (6 products)
- - NRL4: Research Institute for Tropical Medicine (RITM) will be responsible for the assessment of the technical performance of COVID-19 reagents and test kits.
Leptospirosis test kits and reagents, and pregnancy test kits or reagents that utilizes specimens other than urine are also considered registrable but performance evaluation by an NRL will not be performed.
Interested applicants of the mentioned products need to comply with the list of requirements in Annex A of this regulation. The registration fee would be PHP 1,010 for the initial application with 1 year validity while PHP 5,050 must be paid for the renewal of the certificate with 5 years validity.
Updated Technical Requirements for COVID-19 Test Kit Regulation
Since the start of the pandemic in 2020, PFDA has been issuing Special Certifications for COVID-19 test kits. In this regulation, the transition to a Certificate of Product Registration was detailed.
All COVID-19 Test kits with pending initial and renewal application for Special Certification shall still receive a Special Certification upon approval. After expiry of the special certification, the applicant must apply for a Certificate of Product Registration (CPR). This is also true for all COVID-19 test kits with a valid special certification.
CPR application can be applied as early as 6 months prior to the expiry of the Special certification.