Market Information
China’s healthcare expenditure reached over 8.5 trillion yuan in 2022.
Market Trend: In 2020, the total income from commercial health insurance premiums in the nation reached 817.3 billion yuan, showing an average annual growth rate of 20%.
China’s medical equipment market reached $44.8 billion in 2023, constituting roughly 8% of the global total. Projections suggest that China's medical devices market is anticipated to expand at a compound annual growth rate (CAGR) exceeding 5% until 2025. Approximately 95% of the populace had secured at least basic health insurance coverage. Basic medical insurance comprises two systems: employee medical insurance and resident medical insurance.
The establishment of the National Medical Products Administration stemmed from the prior State Food and Drug Administration (SFDA). Initially restructured and renamed as the China Food and Drug Administration in March 2013, this regulatory entity was upgraded to a ministerial-level agency. As part of China's 2018 government administration restructuring, the name transitioned to the 'National Medical Products Administration' and merged into the newly established State Administration for Market Regulation. Its headquarters are located in Xicheng, Beijing.
Medical Device Regulation
National Medical Products Administration (HSA), under the SAMR.
Classification, Fees, Timeline
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Product Registration Routes
Class I, II, III
Useful Information
Validity of License: 5 years.
License transfer: The process of transferring a China Legal Agent typically requires approximately two months.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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