Thai FDA has recently launched the 'Thailand FDA – WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs),' an expedited medical device registration program aimed at curtailing the lengthy duration of registration for manufacturers and importers. As part of the program, the Medical Device Control Division of Thailand FDA has been recognized as a reference agency by the World Health Organization (WHO). Under this initiative, the Thai FDA will assess the performance and safety of the medical device in cooperate with the WHO’s evaluation report.
Conditions of Participation:
1. An in vitro diagnostic kit registered in WHO prequalification (WHO PQ) i.e., Malaria, Hepatitis C, Hepatitis B, HPV, G6PD, Cholera, Syphilis, Tuberculosis NAT, Haemoglobin POC, Glucose meters & test strips. (List of WHO prequalified IVD)
2. As a risk classification 2-4 (moderate to high risk) of an In Vitro Diagnostic Medical Device (IVD)
HIV, Methamphetamine and COVID-19 test kits are not included in the WHO CRP according to the Notification of the Ministry of Public Health RE: HIV IVD test kit year B.E. 2552 (2009) and 2562 (2019), Notification of the Ministry of Public Health RE: Methamphetamine IVD test kit year B.E. 2556 (2013) and 2559 (2016) and Notification of the Ministry of Public Health RE: COVID-19 IVD test kit year B.E. 2564 (2021)
1. The registration cost will be reduced by 53,000 baht (yet depends on its risk classification), a waiver cost on the expert review process.
2. The average reviewing times for qualifying medical devices will decrease from 250-300 calendar days to only 30 calendar days.
To proceed with the registration under this route, the manufacturer or importer shall provide the documents listed below and apply for a medical device license through the electronic submission system (e-submission):
- (1) The registration documents in the form of the Common Submission Dossier Template (CSDT) that is identical to the technical information in the registration dossier approved by WHO/PQT.
- (2)The change notification documents that are authorized by the WHO (if any).
- (3) A letter to request a participation in the CRP.
- (4) The evidence of IVD product registration in the WHO.
- (5) Appendix 3A with signatory and company stamp.
- (6) Appendix 2 with signatory and company stamp.
● Thailand FDA – WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)
● List of WHO prequalified IVD
● Appendix 3A: Expression of interest to national regulatory authority (NRA) in the assessment and accelerated national registration, acceptance by NRA and notification of Procedure outcomes
● Appendix 2: Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the Procedure