World Health Organization (WHO)
TMDA participates in the WHO prequalification Collaborative Procedures for Accelerated registration of IVDs (CRP) and Emergency Use Listing procedures – Facilitated procedure (EUL – FP) for both emergency and routine authorization of medical devices and IVDs of WHO prequalified and Listed In Vitro Diagnostics.
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)?
Is a voluntary procedure whereby an applicant agrees to share with TMDA the assessment reports developed during WHO – prequalification. It is a collaboration between TMDA and WHO in the effort to reduce duplication of work and to ensure timely accessibility of products
Who can apply?
An applicant of an IVDD which has been pre-qualified by WHO
How to apply?
- Applicants should voluntarily express interest in applying the procedure for accelerated registration of their prequalified products by filling the WHO expression of interest form (Appendix 3);
- Applicants should authorize WHO to share its assessment and inspection outcomes for the specific product(s), with TMDA by filling the who consent form (Appendix 2);
- An applicant must submit the same dossier to TMDA as the one approved by WHO for prequalification, along with TMDA application form for registration and Appendix 3 form;
- Requirements for TMDA online submission and fees for registration of in-vitro diagnostic devices remains the same.
Why apply for WHO – CRP?
Shortens registration process by:
- Utilizing available resources and reduce duplication of efforts
- Waiving in country performance evaluation of the IVDD
- Conducting desk review of manufacturing facility in lieu of physical quality audit of the site
For more details regarding CRP, please click here.