CFDA Order No.4
The Provisions for Medical Device Registration，revised at the executive meeting of the China Food and Drug Administration on June 27,2014
Director :Zhang Yong
July 30, 2014
Provisions for Medical Device Registration
Chapter 1 General Provisions
The Provisions are formulated in accordance with The Regulations for the Supervision and Administration of Medical Devices with a view to standardizing the registration and filing administration of medical device and guarantee the safety and effectiveness of medical devices.
All medical devices sold and used within the territory of the People´s Republic of China shall comply with the Provisions to apply for registration or conduct filing .
Medical device registration refers to approval process conducted by the food and drug regulatory authority upon an application submitted by the registration applicant，follows the legal procedure to decide whether the medical device to be marked can be approved or not based on a comprehensive assessment on research and its result of medical device´s safety and effectiveness.
Medical device filing refers to the food and drug regulatory authority files filing materials submitted by the filing applicant for future reference.
Registration and filing shall follow the principle of publicity,justice,and equity.
Filing administration shall be implemented for Class 1 medical devices.Registration administration shall be implemented for Class 2 and Class 3 medical device.
Filing for Class 1 domestic medical device,the filing applicant shall submit the filing to the food and drug regulatory authority of the municipality consisting of districts.
Class 2 domestic medical devices shall be inspected by the food and drug regulatory authority of the provinces ,autonomous regions,municipalities directly under the central government,and the Registration Certificate for Medical Device will be granted after approval.
Class 3 domestic medical devices shall be inspected by the China Food and Drug Administration ,and the Registration Certificate for Medical Device will be granted after approval.
Filing for Class 1 imported medical device,the filing applicant shall submit the filing to CFDA.
Class 2 and Class 3 imported medical shall be inspected by the CFDA,and the Registration Certificate for Medical Device will be granted after approval.
The medical devices from HongKong,Macau and Taiwan shall be registreted or filed to the imported medical devices.
The registration applicant and filing applicant shall launch product to the market in its own name and hold legal liability for the product.
The food and drug regulatory authority shall publicize information of medical device registration and filing according to the regulations.The applicant can inquiry the approval process and results,the public can look up approval results.
China encourages research and development and innovation of medical devices,contributes to promotion and application for new technology of medical devices and boosts the development of medical device industry.
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