World Health Organization (WHO)
TMDA participates in the WHO Prequalification Collaborative Registration Procedure (CRP) for accelerated registration of in vitro diagnostics (IVDs), as well as the Emergency Use Listing – Facilitated Procedure (EUL-FP) for both emergency and routine authorization of medical devices and IVDs that are WHO-prequalified or listed.
Areas of CRP reliance
- Dossier assessment
- Performance evaluation
- GMP inspection of the manufacturing site
- Approval of changes
What is the WHO Collaborative Registration Procedure (CRP)?
The WHO Collaborative Registration Procedure (CRP) is a voluntary mechanism designed to accelerate the national registration of WHO-prequalified in vitro diagnostics (IVDs) and other health products. Under this procedure, the applicant consents to share with TMDA the assessment reports generated during the WHO prequalification process. This collaboration enables TMDA to leverage WHO’s rigorous evaluation outcomes, reducing duplication of regulatory work and facilitating the timely availability of quality-assured products to the public.
Who can apply?
Manufacturers or marketing authorization holders of WHO-prequalified IVDs can apply for participation in the CRP.
How to apply?
Applicants wishing to use the procedure for accelerated registration of their WHO-prequalified products should:
- Express interest by completing the WHO Expression of Interest Form (Appendix 3);
- Authorize information sharing by submitting the WHO Consent Form (Appendix 2), allowing WHO to share its assessment and inspection outcomes for the specific product(s) with TMDA;
- Submit documentation to TMDA, including the same dossier approved by WHO for prequalification, the TMDA application form for registration, and the completed Appendix 3 form;
- Comply with existing requirements, as TMDA’s online submission process and registration fees for in vitro diagnostic devices remain unchanged.
Why apply for WHO – CRP?
Shortens the registration process by:
- Leveraging existing resources and minimizing duplication of efforts;
- Waiving in-country performance evaluation of the in vitro diagnostic device (IVDD);
- Conducting a desk review of the manufacturing facility in place of an on-site quality audit.
Benefits of WHO CRP to TMDA Staff
- Capacity building for assessors through exposure to WHO evaluation processes.
- Facilitated decision-making through providing assessors with reliable, pre-verified technical data to support quicker, evidence-based approvals.
- Knowledge transfer from WHO experts to improve technical skills in dossier assessment and quality system audits.
- Professional networking with other regulators and WHO technical teams.
For more details regarding CRP, please click here.