In-vitro diagnostic equipment

Thailand: Collaborative Registration Procedure (CRP) of Thailand FDA – WHO for In-Vitro Diagnostic Products

The Medical Device Control Division, Thai FDA has been recognized by WHO as a reference agency, which allows Thailand to participate in the Collaborative Registration Procedure (CRP) program, that can shorten the duration of registration. The Thai FDA will assess the performance and safety of the medical device in cooperation with the WHO’s evaluation report. This program will be effective starting from 23 January 2023.

Conditions of Participation:

  1. An In-Vitro Diagnostic (IVD) kit registered in WHO pre-qualification (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 can be found here.
  2. IVD medical device with risk classification 2 – 4 (moderate to high risk).

Exclusion: 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)

Advantages of the Program:

  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.

For more information on the process to participate in the CRP program, please refer to this link.

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