Thai Cabinet Approves Draft Amendment to the Medical Device Act
On November 3, the Cabinet approved in principle the draft amendment to the Medical Device Act (“Draft Amendment”) as proposed by the Ministry of Public Health ( MOPH).
The Draft Amendment aims to provide better protection to consumers, ensure compliance with the ASEAN Agreement on Medical Device Directive ( AMDD) and international guidelines, and relax certain regulations to assist medical device operators. Significant amendments under the Draft Amendment include:
• revising the definition of “medical device” and adding definitions of “accessories” and “notification applicant;” • rewriting the classifications of groups of medical devices or medical devices according to the risk assessments; • assisting operators by revoking customs verification measures in the case of medical devices export; • revising the timeline of the application process, and revising advertisement restrictions; • adding a provision on penalty for the notification applicants, as well as increasing the penalty to be compatible with the present environment.
For more information contact Baker & Mckenzie at peerapan. tungsuwan@ bakermckenzie. com.