In brief

Pursuant to our previous articles about medical devices and their development in Thailand following the Medical Device Act B.E. 2551 and its amendments, which were adjusted according to the ASEAN Medical Device Directive (AMDD), there have been more updates on the medical device regulations under the Thai Food and Drug Administration (FDA).

Key Takeaways

The groups of medical devices and medical device classifications from risk assessments are now clear. Some medical devices were reclassified (e.g. surgical gloves from being Class III to Class II and active machinery and equipment from being Class I to Class II) and the quality standards for certain types of medical devices have been established (e.g. medical masks and surgical gloves) to ensure that they are suitable for use in accordance with the manufacturer's intended uses. In addition, registration and notification are now carried out electronically, and a pre-submission process is added as the first process. This process can be challenging as it requires good knowledge of medical device classification and grouping as this will help contribute to a successful registration or notification.