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

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

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An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

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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 NMPA Updates Medical Device Classification Catalogue

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China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.

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China to Regulate Medical Device Advertising

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China is developing new standards and processes for the regulation of advertising for medical devices (as well as pharmaceuticals, food supplements and cosmetics). The goal is to maintain the order of the advertising market, standardize the review of advertisements and protect the rights and interests of consumers.

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China NMPA Adds 47 Products to Clinical Trial Exemption List

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China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.

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Medical Device Advertising Requirements in Asia

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In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

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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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How New EU MDR Requirements Will Affect Registrations in Asia

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As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

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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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