The Ministry of Public Health Thailand has published the medical device risk base classification to conform to the ASEAN Agreement on Medical Device Directive (AMDD). This came into effect on the 19th December 2019.
Refer to the Medical Device Act 2008 and the 2nd revision Medical Device Act 2019, there are some modifications as the following:
1) Classify the medical devices into 2 groups
1.1 In Vitro Diagnostic (IVD) Medical Devices
1.2 Non-In Vitro Diagnostic (Non-IVD) Medical Devices
2) To classify IVD medical devices by risk base to individual and public health from low risk to high risk
2.1 Class 1 Medical Device: Low individual risk and Low public health risk
2.2 Class 2 Medical Device: Moderate individual risk and/ or Low public health risk
2.3 Class 3 Medial Device: High individual risk and/ or Moderate public health risk
2.4 Class 4 Medical Device: High individual risk and High public health risk
3) To classify Non-IVD medical devices by risk base that might be occurred from low risk to high risk
3.1 Class 1 Medical Device: Low risk
3.2 Class 2 Medical Device: Low-Moderate risk
3.3 Class 3 Medical Device: Moderate-High risk
3.4 Class 4 Medical Device: High risk
4) TFDA secretary department has authorize to finalize the medical devices classification should there be any issues of medical devices classification
5) There are Medical Device Control for the risk base medical devices classification
5.1 Licensed Medical Devices CSDT Submission
5.2 Notified Medical Devices CSDT Submission
5.3 Listing Medical Devices* (e-Listing) Non-CSDT Submission
*Amendment of Medical Device Act 2008
6) This notification will be effective on the day after the publication of Thai government gazette
The regulation (Thai version).
MDCD official launch of Medical Devices Risk Classification Tool (Thai version) which is now available online HERE.