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To promote and support research and development of medical devices in Thailand, the Ministry of Public Health (MOPH) and the Food and Drug Administration (FDA) have recently issued several notifications providing additional guidance for manufacturers or importers of certain medical devices seeking exemptions from licensing requirements (i.e., the manufacturing or import license, and the product registration license) under the Medical Device Act ("License Exemptions").
The MOPH issued a notification which requires the manufacturer or importer of medical devices for use in human clinical research to provide the letter of approval from the Human Research Ethics Committee (i.e., the relevant Independent Ethics Committee or the Institutional Review Board) which has been approved by the FDA, in order to apply to obtain the License Exemptions. To this end, the FDA subsequently issued a further notification to set out the criteria, methods and conditions for approving the Human Research Ethics Committees which can oversee clinical research in humans related to medical devices.
Separately, the FDA issued a notification to outline the criteria for importing medical devices in quantities as required for personal use, which exempts the importer from the requirement to provide a certification letter from the healthcare professional as part of the process to obtain the License Exemptions. This notification also sets out the types of medical devices (and their quantities) which will qualify for such exemptions under each specific importation scenario as set out under this notification.
For more information or assistance, please contact our Healthcare & Life Sciences and Regulatory Affairs Services team.
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