Thailand: Thai FDA Issues Guidelines and conditions for submission of medical device product diagnosis - May, 2018
- 2020-08-06 09:09:52
Thai FDA announces that they will modify the Medical Device Act and will be adopting the international risk classification method (Class I-IV) in order to comply with the ASEAN Agreement on Medical Device Directive.
MoreThai FDA published an eye-related product classification checklist guide to help determine whether each product fall under the category of not medical device, medical device, drug, or cosmetic.
MoreOn 30th of November 2017, following recommendation from the Advisory Board, Thai FDA had announced four new checkpoints which regulate importation and exportation of medical devices. The new checkpoints are located in four different provinces as follows:
MoreThe Thai Medical Device Control Division has amended the application form for medical device advertising following the Thai FDA announcement on 19 January 2018. It is appropriate to report complete and clear information to monitor the impact of disclosure.
MoreThailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.
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