The MHRA are the authorities responsible for medical device regulations throughout the United Kingdom.
In March 2020, the MHRA updated its guidance on distinguishing medicines and medical devices focusing on cases
Regulatory News
USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs)
USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs).
CGTs designation was created under FDA Reauthorization Act of 2017 (FDARA) with the purpose of
Singapore adds controls to certain mercury-added medical devices under EPMA
Singapore adds certain medical devices to the control list of Mercury-Added Products under the Environmental Protection and Management Act (“EPMA”).
From 1 January 2020 onwards, the manufacturing, import and export of
Singapore HSA released registration requirements on Next Generation Sequencing IVDs
Singapore, Health Sciences Authority (HSA) released the final document on Next Generation Sequencing NGS IVDs.
This document focuses on the requirements of NGS IVDs for registrations.
The scope covers both NGS based
Malaysia, guidance document for the pre-submission meeting.
Malaysia, guidance document for the pre-submission meeting.
On 13th February 2020, the Guidance Document for Pre-Submission Meeting (PSM) was unveiled.
PSM a new service provided by the Nationalized Regulatory Division of Pharmacy.
China, NMPA announces the publication of guidance document on medical device registration
China, NMPA announces the publication of this guidance document to further strengthen the administration and supervision on medical device registration, as well as to improve the efficiency and quality of
Japan, Updated guidance on biocompatibility testing of medical devices
Japan, Updated guidance on biocompatibility testing of medical devices
Updated guidance relating to biocompatibility testing of medical devices was released by The Ministry of Health, Labour and Welfare of Japan in
USA, FDA launched Guidance Snapshots
A brand pilot program has been launched in February 2020 by the US FDA on Guidance Snapshots.
These new Guidance Snapshots would be covering topics relating to modernizing drug clinical trials
UK will not be acting as a leading authority for medicines during Brexit transition
UK will not be acting as a leading authority for medicines during Brexit transition.
Medicines and Healthcare products Regulatory Agency (MHRA) confirmed in a statement in February 2020 that during the