NMPA publishes a clear guidance to regulate the raw material change in medical device. In this guidance, it points out three major changes on material component and how to perform the risk assessment on raw material change.
More NMPA drafts a new guidance document of human factors (Usability) for medical device, the Class II and Class III devices are applicable once implementation. Now NMPA seeks for public comment.
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Despite the effect of COVID-19 outbreak, ThaiFDA continued to perform at its best for the Medical device regulation reform update. Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Thai FDA Announced that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration.
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A new guidance document on this has been issued with the requirements to be followed: All orphaned, obsolete and discontinued medical device still in active use must now be notified with MDA.
More Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020, in order to gradually promote the transition of Thailand future regulation implementation.
More Although Thailand has decreased the numbers of infections significantly yet to relieve since the disease is very contagious. Food and Drug Administration is decidedly in concern that Thailand shall have enough resources in hands to dispute this COVID-19 Outbreak via the Fast Track option developed by ThaiFDA for manufacturer and importer of COVID-19 related products.
More On 2011, China NMPA published the 1st edition of “Guidance of Adverse Event Monitoring for Medical Device”. Now, they make a dramatic change on the adverse event system and modify the guidance according.
More NMPA of China released the registration work report in April 2020, covering the milestones of medical device regulations and registration applications from last year. In addition to actively improving relevant regulatory regulations and standards, NMPA also gradually adjusts its internal operating methods.
More NMPA has revised the quality inspection measure of medical devices to show their determination on strengthening post-market surveillance. The worst-case scenario manufacturers may face in PMS would be total product recall.
Guiding manufacturers to develop medical devices which are safe and high performing, NMPA has released basic principles of investigation for all class of medical devices.
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