Thai FDA Classification Rules for Medical Devices
The Thai Food and Drug Administration (Thai FDA) regulates both medical devices and in vitro diagnostic (IVD) devices using a four-tier, risk‑based classification system aligned with the ASEAN Medical Device Directive (AMDD). All device types fall under the same four classes, which determine registration routes and required documentation:
- Class 1 – Low risk (requires Listing) - Bandages, surgical instruments (reuseable), examination glove, blood collection tube, clinical chemistry analyzer
- Class 2 – Low‑moderate risk (requires Notification) - Hearing aid, nebulizer, orthodontic wire, pregnancy test, fertility test
- Class 3 – Moderate‑high risk (requires Notification) - Hip implants, implantable devices, joint replacement, glucose monitoring, blood gas
- Class 4 – High risk (requires Licensing) - Pacemakers, heart value, filler, HIV test kits
Thai FDA updated its classification scheme from a three-tier system in 2021. These regulatory changes took effect starting February 2021 for Classes 2–4, and Class 1 listing became mandatory in March 2021.
How Medical Devices and IVDs Are Classified in Thailand
Classification of non-IVD medical devices depends primarily on the device’s intended use, invasiveness, duration of use, and biological effect. For IVDs, the Thai FDA applies risk factors such as purpose of use, indications for use, user expertise, and impact on public health.
While Thailand follows ASEAN rules, it also enforces specific Thai regulations that interpret ASEAN criteria. TFDA encourages manufacturers to confirm their device’s classification before submitting their registration application via Thailand’s e-submission system. The system will assign the device class and validate grouping eligibility within 15 days of receipt.
Medical device and IVD grouping in Thailand
Thai FDA allows devices across all classes to be grouped under a single registration if they meet defined grouping criteria:
- One generic proprietary name
- One product owner
- One common intended use
Grouping types include:
- Single – complies with the three general rules, and ranges in package size and/or number of units.
- System – follows the three general rules and contains accessories that work in combination with the medical device to achieve a common intended purpose. The label, user manual, and brochure/catalog must all denote the same purpose.
- Family – products that comply with the three general rules and have a common risk classification, design, and manufacturing process but may slightly differ from each other.
- Family of system - complies with the three general rules and have common risk classification, same brand name, design, and manufacturing process but may slightly differ from each other. The main components of the system can vary but must fall under permissible variants.
- Set – Only for Non-IVD devices. consists of two types of medical devices that comply with the three general rules and are imported and sold in the same packaging. Risk classification is based on the device with the highest risk.
- IVD Test Kit – complies with the three general rules and labelled as an IVD test kit (excludes analyzers).
- IVD Cluster – complies with the three general rules and manufactured by a common entity, either Type 1 or Type 2 risk, and shares a common methodology (e.g., may contain two different test kits, reagents, and other articles).
Grouping is determined during the pre‑submission phase. Approved groups can submit a single dossier under the Common Submission Dossier Template (CSDT).
