Announcement of 2nd Royal Decree on Medical Devices: Focusing on Aligning the Standard and Measure o
8 January 2020
The second Thai royal decree on medical devices has been announced in royal gazettes since 30th April 2019. The main objective of the decree focuses on aligning the standard and measure of Thai medical devices to be following the ASEAN agreement on Medical Devices. The new decree is in line with the change in industry and global trade of medical devices and beneficial for Thai citizen since the importance of international standardization of medical devices and their safety. In addition, the decree fosters development and investment of entrepreneur in medical devices industry with the following key points.
- Under sections 6 to 8 of the new royal decree, the medical devices will be categorized based on public healthcare standards with additional regulatory measures on the production and import of low-risk medical devices.
- Under section 9, there will be an establishment of a medical device inspection center for the import goods. Also, the existed inspection measure for the exported medical devices will be ineffective in facilitating the business of exporter and entrepreneur.
- Under section 37, The advertising of specific medical devices directly to medical and medicinal practitioners would be allowed without permission to facilitate the business and research and development of medical devices.
That is, “The direct advertising (measure, method, and conditions) of medical devices to medical, medicinal, and public health practitioners would need no permission under the direction of minister under the guidance of steering committee.”
- The fine and punishment of violating the decree will be adjusted by supporting laws and are in line with the current situation with proper adjustment of related measures.
- The regulatory fees will be rationally adjusted.
- The regulatory permission process of medical devices will be effectively upgraded. The processes compose of not only document checking, academic document assessment, analysis and inspection of the facility, inspection approval document, registration, permission, detailed announcement document, registered announcement, inspection certification, but also other related inspections
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