Thailand Medical Device Classification

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:

• Class 1
• Class 2
• Class 3
• Class 4

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 Class 2 and 3 products eligible for the Notification Route include:

• Fertility Tests
• Blood 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
• Self-tests

Examples of Class 4 products requiring registration through Licensing include:

• HIV
• HCV
• HBV
• HTLV