Thai FDA: Medical Device Act (2nd edition)


The Thai Food and Drug Administration released the amended Medical Device Act (2nd edition) 2019 which will replace its predecessor, the Medical Device Act of 2008. The amended Medical Device Act (2nd edition) 2019 will come into effect in October 2019 and below is the table summarising the key amendments.

ThaiFDA medical device risk classification on-line tool is already available in preparation to this amended Medical Device Act.

Reference: Thai Food and Drug Administration

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