• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations on Good Clinical Practice for Medical Devices”. This article provides a comparison between the current specification and the upcoming regulation.

• 2020-06-16 08:03:29

MDA has recently announced that it will no longer consider Notification of Special Access (Route A) applications to manage COVID-19 medical device shortage in the country.

• 2020-06-16 08:03:29

This draft of medical device definition for manufacturers and importers to follow when registering their medical devices according to risk-based classification, to emphasize the milestone transition of Thailand away from policy-based classification.

• 2020-06-16 08:03:29

NMPA released the Draft Revision of Guidance of Software for Medical Device Registration, which increased the scope of application, while paying more attention to the review of technical documents.

• 2020-06-16 06:31:23

Ministry of Public Health Announcement regarding the Standard of Medical Device that Manufacturer or Importer must Comply 2020, is one of the countless Thai FDA Regulatory updates in June. Manufacturer and Importer may refer to this announcement as collection of guidance which standard of listed Medical Device can be denote to.

• 2020-06-16 05:19:05

To ensure the safety and efficiency of adopting human factors/usability engineering evaluation while manufacturer developing medical devices, this guidance provided an overall concept and guide, including product design, development, registration, and post-market related matters.

• 2020-06-11 10:00:48

Health Sciences Authority (HSA) is informed to the increased demands for medical products relevant to COVID – 19. Various establishments have considered 3D printing (3 – DP) to address the issue of limited supply of medical products.

• 2020-06-11 09:48:40

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.

• 2020-06-11 09:41:54

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.

• 0000-00-00 00:00:00

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.