โครงการความร่วมมือในการขึ้นทะเบียนเครื่องมือแพทย์ที่เป็นชุดตรวจวินิจฉัย (IVD) ผ่านโครงการ CRP ร่วมกับ WHO
(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
