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China’s National Medical Products Administration (NMPA)
The China National Medical Products Administration or NMPA is the national regulatory body and competent authority for medical devices and in-vitro diagnostics (IVDs) in China. In 2018, the name was changed from the State Food and Drug Administration or SFDA to the NMPA. The NMPA is based in Beijing and overseas the regulation of drugs, medical devices (including IVDs), and cosmetics. They regularly issue new notices, draft guidance, regulations, and compulsory standards on their website (EN / CN)
More information on the NMPA and their mission, as well as their leaders, can be found here.
Recent History of the NMPA
The NMPA has gone through several significant changes over the last 10 years as they try to establish themselves as an internationally recognizes regulatory body. At this time, approval by China’s NMPA is not recognized as a Reference Country and eligible for expedited review in most countries. As the NMPA continues to build out their standards and align with global expectations, this is expected to change, significantly benefiting local Chinese manufacturers and early market entrants seeking medical device registration in Southeast Asia.
Asia Actual’s new tool for RA professionals, R.O.S.E., can help identify Same-Type devices (aka Predicate Devices) and their classification. Click here to learn more.
Significant Recent NMPA Regulatory Updates
The NMPA has made several significant updates in the last few years including the following:
- Transparency on clinical trials (clinical trial exemption) and CER guidelines for several product categories,
- More classification guidance and official feedback routes prior to officially submitting applications,
- Improved review times,
- Easy transfer of product licenses from one Agent to another.
Recent Asia Actual Articles on China’s NMPA Updates
- China NMPA Updates Compulsory Standards for Medical Devices
- China Releases Draft Clinical Evaluation Exemption List For 2022
- Medical Device Advertising Requirements in Asia
- China’s NMPA Publishes Classification Catalogue Adjustments for Comment
- Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
- China’s NMPA Begins Issuing Registration Certificates Electronically
- China Fully Implements UDI Requirements for Class 3 Medical Devices
More Information on NMPA Regulatory Requirements for Medical Devices
- Asia Actual’s Overview of the Medical Device Registration Process
- Asia Actual’s Overview of the Clinical Data Requirements in China
- NMPA Regulations: http://camdi.org/law/index
- NMPA Technical Standards: http://camdi.org/tech/index
- NMPA Medical Device related news and announcements: https://www.nmpa.gov.cn/ylqx/index.html
China Regulatory Support
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