A list of recently published articles regarding medical device regulatory updates from the NMPA and other governing bodies in China.

Hainan Island’s Special Access Program for Medical Devices

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On May 1, 2023, Hainan Province reaffirmed its special access program to for the importation of urgently needed drugs and medical devices.

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China Updates Medical Device Clinical Evaluation Pathway Guidance

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In March of 2024, the CMDE added 25 devices to the “Guidelines for Deciding Whether to Conduct Clinical Trials on Medical Devices”.

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China NMPA Updates Compulsory Standards for Medical Devices

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On November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.

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China Releases New List of Standards for Medical Device Registration

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The NMPA has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.

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China’s Third Batch of UDI Implementation Deadline in June

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Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.

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China’s NMPA Publishes Classification Catalogue Adjustments for Comment

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On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.

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China Fully Implements UDI Requirements for Class 3 Medical Devices

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Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.

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China to Require All Electromedical Devices Meet Updated Standards

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This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

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China to Implement New Electrical Safety Standards for Medical Devices

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An updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023.

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China Publishes 9 Draft Guidelines for Registration of Medical Devices

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Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.

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