Thailand FDA – WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)

Thailand FDA – WHO CRP is an expedited medical device registration program between regulatory agency that make an offer to the manufacturer or importer to shorten the duration of registration. Since the Medical Device Control Division, Thailand FDA has been recognized the WHO (World Health Organization) as a reference agency, in this program, 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.
2. HIV, Methamphetamine and COVID-19 test kits are not included in WHO CRP according to 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)
3. As a risk classification 2-4 (moderate to high risk) of an In Vitro Diagnostic medical device (IVD)

Advantages

1. The registration costs will be reduced by 53,000 baht (depends on its risk classification), a waiver cost on the expert review process.
2. The average review times for qualifying medical devices will decrease from 250-300 calendar-day to 30 calendar-day.

Process

1. Business operators as specified in the establishment license of medical device (applicant in Thailand) with acknowledgement of product owner sign a letter appendix 3A to request a participation in the CRP send to Thai FDA (NRA). And send a copy of appendix 3A to WHO via prequalreg@who.int
2. Applicant by the acknowledgement of product owner sign a letter appendix 2 sends to WHO via prequalreg@who.int     
3. Applicant submits an application for an IVD product license through the electronic submission (e-submission) system by attached documents as following:
   (1) The registration documents in the form of 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) The letter to request a participation in the CRP.
   (4) The evidence of IVD product registration in WHO.
4. After receiving an application number in the e-submission system, Thai FDA will submit appendix 3B to the WHO, WHO will give a permission to deliver the evaluation report of IVD product via MedNet to CRP focal point IVD group, Medical Device Control Division, Food and Drug Administration, Thailand.

Responsibility of importers (applicant in Thailand) Contact product owner for appendix 3A and appendix 2, sends appendix 3A to Thai FDA included in e-submission system, sends appendix 2 and copy of appendix 3A to WHO.

Responsibility of product owner Acknowledge and complete the appendix 3A and appendix 2, including mandatory information i.e. WHO prequalification (PQ) reference number.

For more information IVD Medical Device, Medical Device Control Division,
Food and Drug Administration, Thailand. Tel: (+66)2-591-8479
Email: IVD_THFDA@fda.moph.go.th