Medical devices are classified in Thailand according to the intended use, level of risk, delivery method, and the degree of invasiveness in the human body.
Devices are classified into one of the following, from lowest to highest risk:
While classification rules closely align with the ASEAN MDD guidance, the Thai FDA has also included specific rules for each registration route.
IVD Classification Rules
IVDs in Thailand are classified into 4 categories (1 through 4) based on risk and closely follow ASEAN MDD guidance. Guidance for classifying products according to Annex 2 of the ASEAN MDD but additional guidance and Thai specific rules can be found below (English translation to come soon).
Factors affecting the risk include:
Purpose of use and indications
Expertise of the medical device user
Importance and Impact of the Medical Device Information on Individuals and Public Health.
Examples of 2 and 3 products eligible for the Notification Route include:
Blood Type Testing
STD Tests (e.g. chlamydia or gonorrhea)
Prenatal Tests (e.g. rubella, toxoplasmosis, spina bifida or down syndrome)
Infectious disease tests that influence life threatening treatment decisions (e.g. enteroviruses, CMV, Herpes simplex virus (HSV) in organ transplant patients)
Blood glucose monitoring
Examples of Class 4 products requiring registration through Licensing include:
Guidance Document Name
Ministerial Regulations, Medical Device Products required Listing Approval
Outlines classification criteria for a Class 1, Listing category.