The European Commission is working on a proposal to delay the implementation of the EU 2017/745 Medical Devices Regulation (MDR / the Regulation) until 2021.
This implementation which was due to
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USA, FDA finalized their guidance on 510(k) third party review program (3P510k)
This guidance provides details on how types of devices are eligible for third party review and explain how third-party review organizations are being recognized.
The 38 paged guidance provides and explains
read more...UK, MHRA updated guidance on medicines and medical devices
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
read more...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
read more...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
read more...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
read more...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.
read more...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
read more...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
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