Tag Archive for: China

China CMDE Supplementary Documents Submission Deadline Extended

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On February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months.

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China Continues to Implement UDI of Medical Devices with Third Batch Release

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The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II 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 NMPA Updates Classification of Sodium Hyaluronate Products

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On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.

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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’s NMPA Begins Issuing Registration Certificates Electronically

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On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.

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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 to Accept Foreign Generated Test Reports

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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’s Green Pathway Registration for Innovative Medical Devices

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China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.

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