Medical Device Registration Routes

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

Scope of application:

All medical devices that are intended to be declared

II. Emergency examination and approval

Scope of application:

Applicable to the emergency needs of public health emergencies, and there is no similar product listed in China, or although similar products have been listed in China, the supply of products cannot meet the emergency treatment needs of public health emergencies. The medical devices should be confirmed by the NMPA.

III. Innovation examination and approval

Scope of application:

The following conditions are met at the same time:

1. Through his leading technological innovation activities, the applicant legally owns the patent right of the product core technology invention in China, or obtains the invention patent right or its use right in China through the transfer. Innovative medical device special examination application time is less than 5 years from the patent authorization announcement date; or the application for the core technology invention patent has been published by the patent administration department under the State Council, and a search report is issued by the Patent Search and Consultation Center of the National Intellectual Property Office.  

2. The main working principle/action mechanism of the product is the first in China. The product performance or safety is fundamentally improved compared with similar products. The technology is at the international leading level and has significant clinical application value.  

3. The applicant has completed the preliminary research of the product and has basic stereotyped products. The research process is real and controlled, and the research data is complete and traceable.

IV. Priority examination and approval

Scope of application:

Medical devices that meet one of the following conditions

1. Diagnose or treat rare diseases with obvious clinical advantages;
2. Diagnose or treat malignant tumors with obvious clinical advantages;
3. Diagnosis or treatment of endemic and multiple diseases in the elderly, and there is no effective diagnosis or treatment currently;
4. Dedicated to children with obvious clinical advantages;
5. Clinically urgently needed, and there are no medical devices approved for registration in the same variety of products in China;
6. Medical devices that are listed in the national science and technology major projects or national key research and development plans;
7. Other medical devices that should be approved in priority (nationally designated).

V. MAH

Scope of application:

Meet the following basic conditions

1. The residences or production addresses of the enterprises and scientific research institutions are located in the provinces, autonomous regions and municipalities participating in the pilot.
2. Full-time technical and management personnel related to regulatory affairs, quality management, post-marketing affairs, etc., with relevant knowledge and experience in medical device regulatory regulations and standards.
3. Establish a quality management system that is compatible with the product and maintain effective operation. There are personnel who independently evaluate, review and supervise the quality management system.
4. Ability to take responsibility for quality and safety of medical devices