• 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 07:38:56

In this article, you can gain an understanding in the current Asia eyecare market and its key players. In addition, we will share the marketing strategy from one of China’s aggressive service providers.

• 2020-06-16 08:03:29

PMDA has announced of organizational restructuring of Office of International Programs, aiming strengthening of cooperative relationship with Asian countries.