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

China Releases Draft Clinical Evaluation Exemption List for 2022

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On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.

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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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Asia Actual is the Best Medical Device Consulting Company in Asia

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Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

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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 Issues Recommendation for Medical Device Clinical Data

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For medical device registration in China, one of the most important documents to be provided is  clinical data. 

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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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NMPA Issues New Guidance for Medical Device Software in China

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In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.

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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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