BackgroundIn the past year, many medical device regulations have been revised, and some regulations will take effect in 2019. In 2018, China Food and Drug Administration (CFDA) are reconstructed to National Medical Product Administration (NMPA) and issued significant regulations on classification, registration, inspection and clinical trials. The implement of medical device guiding principles for frequently-used devices, innovative devices and high-risk devices helps medical device enterprises, relevant administrations and clinical institutions understand Chinese registration system and the future trend. The pilot work of medical device MAH system is expanded to Guangzhou and Tianjin. This system will totally change the supply chain and regulatory approval procedure in China. NMPA is strengthening management of overseas enterprises. Acceptance of overseas clinical data, China authorized representative and overseas GMP inspection are considerable for all overseas medical device enterprises.
China is one of the biggest medical device markets for global medical device enterprises. Now we issued the 2018 Annual Report on Chinese Medical Device Regulations for summarizing the essential regulations and data in 2018 as a reference for medical device enterprise to understand Chinese market and make future regulatory strategy.
Content Covered Registration and Approval Condition in 2018
Summary of China Medical Device Regulations
Interpretation of the Implemented Regulations in 2018
Main Medical Device Industry Development Report in China
China Medical Device Classification Catalog
China IVD Classification Catalog
China Medical Device Catalog Exempted from Clinical Trials
China IVD Catalog Exempted from Clinical Trials
How to Get the Annual Report and Medical Device CatalogFill in the Order Form , and send it to firstname.lastname@example.org to purchase the 2018 Annual Report on China Medical Device Regulations and China Medical Device Catalog.You can acquire the Free Preview of the Annual Report here.
EditorCIRS Medical Device Business Unit is a professional team which has a long-term commitment to researching product technology, laws and regulations and industry police of domestic and overseas medical devices. With professional and technical experiences, multiple resources and global network, medical device BU assists domestic and overseas medical device enterprises with a comprehensive service chain and one-stop solution in medical devices regulation and technical consulting service.
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