Recent Regulatory Changes
Thai FDA · MDCD · 2024–2026 developments
2021 — Framework in Force
The Medical Device Act B.E. 2562 (2019) entered into full force on 15 February 2021, marking the most significant reform to Thailand's medical device regulation. All new registrations have been processed under this framework since then.
Key Features of the Current Framework (for Reference)
| Feature | Detail |
|---|---|
| Three approval pathways | Listing (Class 1) · Notification (Class 2–3) · License (Class 4) |
| 5-year validity | All approvals — renewal mandatory |
| CSDT dossier | Full format required for Class 2–4 |
| Establishment License | Mandatory for all operators |
| Concise/Reliance route | Available for devices with reference NRA approval |
| NBTC dual approval | Required for wireless/BT/Wi-Fi devices |
| Thai language labelling | Mandatory for home-use devices |
| 180-day label affixing grace period | For importers applying Thai labels post-import |
| Grouping rules | Six types: Single/Family/System/Set/IVD Test Kit/IVD Cluster |
ASEAN Harmonisation Updates
Thailand participates in ongoing ASEAN AMDD harmonisation activities:
- ASEAN CSDT updates — ASEAN periodically revises the CSDT format; Thai FDA implements applicable changes
- Classification alignment — ASEAN member states continue to harmonise classification rules
- Reliance framework expansion — ongoing discussions to expand the set of recognised reference NRAs
Positive List Additions — TH-Unique
The Thai FDA Positive List of Class 1 devices eligible for the Listing pathway is updated periodically. When new device types are added to the Positive List, manufacturers of those devices can switch from the Notification pathway to the simpler Listing pathway on renewal.
Action: Check the current Positive List from the Thai FDA website before each new application — your device may now qualify for Listing.
Upcoming Changes & Reform Tracker
| Expected Development | Status | Action |
|---|---|---|
| CSDT format updates (ASEAN-level) | Periodic | Monitor Thai FDA website for new CSDT templates |
| Positive List expansion | Ongoing | Check Positive List before each application |
| NBTC regulatory updates | Periodic | Monitor NBTC website |
| SaMD/AI-specific guidance | Under development | Monitor Thai FDA website |
| Fee schedule updates | Annual | Check Thai FDA website |
Monitoring Thai FDA Updates
- Thai FDA website: www.fda.moph.go.th — official notifications, guidance, Positive List
- Thai FDA MDCD: Direct contact for device-specific queries
- NBTC website: www.nbtc.go.th — wireless device approval updates
- ASEAN Secretariat: asean.org — AMDD harmonisation updates
With all approvals on 5-year cycles, create a renewal tracking calendar. Budget 3–6 months for renewal processing and submit well before expiry.