Europe proposes to delay implementation of MDR due to COVID-19

The European Commission is working on a proposal to delay the implementation of the EU 2017/745 Medical Devices Regulation (MDR …

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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 …

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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 …

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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 …

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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”). …

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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 …

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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. …

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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, …

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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 …

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