• 2020-07-16 07:22:55

Taiwan’s FDA has issued a Good Distribution Practice Guideline for Medical Devices. With the new guidelines getting into force in the near future, relevant distributors will be required to obtain a GDP certificate before they can legally distribute medical equipment.

• 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 08:03:29

PFDA released updated guidelines for the importers and manufacturers of PPEs, ventilators, and respirators in relation to the COVID-19 situation.

• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations of the Medical Device Quality Management System. This article provides a comparison between the current and the upcoming regulation.

• 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

PFDA publishes new guidelines regarding License to Operate (LTO)-related transactions for establishments.

• 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

HSA announces a provisional authorization route for devices that decontaminate single use respirators used for COVID – 19 response. In addition, guidelines for healthcare institutions and other facilities that decontaminate respirators have also been published.

• 2020-06-16 08:03:29

Thailand FDA has announced the Draft of medical technical documents preparation to accentuate the milestone transition of Thailand away from policy-based classification and gear toward risk-based classification.