In order to accelerate the transformation of medical device results, promote the development of the medical device industry, China has added several pathways to approval, such as emergency approval procedures, innovation approval procedures and priority approval procedures.
Medical devices that applicable to these new pathways are mainly for sudden public health events, treatment of rare diseases, malignant tumors, geriatric diseases, children-specific, clinically urgent needs, and medical devices listed in the national science and technology major projects or key research and development programs.
The following are some of the existing forms of medical device registration approval in China.
I. Regular examination and approval
All medical devices that are intended to be declared
II. Emergency examination and approval
III. Innovation examination and approval
IV. Priority examination and approval
V. MAH system
Do you want to learn about Chinese medical device regulations? Do you want to know which registration path is more suitable for your product? Do you want to customize a suitable registration strategy for your product?
With rich experience in medical device registration, registration testing, clinical trials and other related fields, CIRS is able to provide companies with consulting services on product design and development, pre-registration compliance analysis and registration strategy, China medical device regulations and registration paths, so that you can find suitable compliance paths for your products.
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Pre-registration compliance analysis and registration strategy consultation