Medical device classification
In China, medical devices are divided into three classes according to the level of risk.
The class I medical device has a low level of risk and routine management can guarantee its safety and effectiveness. Just Record management only.
The class II medical devices with moderate risk requires strict control and management to ensure their safety and effectiveness. Registration is required.
The class III medical devices with higher risks require special measures to strictly control and manage them to ensure their safety and effectiveness. Registration is required.
Definition of classification:
A clear definition of classification will assist in determining how to register, who to file with and the budget for the work. Most regulatory authorities review and supervise products under classification. In China for the enterprise can not judge the product category by themselves, need to be able to apply for category confirmation of medical device products, the enterprise can online declaration, review and results feedback.
Registered unit:
The registration unit determines the number of registration certificates. Different registration units usually do not have the same certificate. Enterprises can be divided by themselves, but also can entrust Lingfu Medical registration unit division assessment. Medical device registration units are usually divided according to the classification of active, passive and in vitro diagnostic medical devices based on the scope of application of the product, technical principles, structural composition, performance indicators, main raw materials and packaging specifications of in vitro diagnostic reagents.
Priority approval:
In line with (a) old evil children urgent, for five kinds of people's products; (2) Major national projects, key research and development products; (3) Other products that should have priority shall be priority objects for examination and approval. The application for the combination of priority approval and first registration is accepted, and the approval of priority products only affects the work progress after acceptance.
Priority approval:
In line with (a) old evil children urgent, for five kinds of people's products; (2) Major national projects, key research and development products; (3) Other products that should have priority shall be priority objects for examination and approval. The application for the combination of priority approval and first registration is accepted, and the approval of priority products only affects the work progress after acceptance.
Innovation approval:
The application for approval of innovation must meet three conditions: (1) the core technology patent right, the invention patent or the right to use, or the application has been made public; (2) The first in the country, international advanced, significant clinical application value; (3) The product is basically shaped, and the real control can be traced. Innovation approval can be applied for separately, and preferential policies will be obtained after approval.
Review and supplement:
In the registration and other work, the review stage asks the enterprise to supplement the information. NMPA stipulates that the technical review supplementary period of 1 year, one opportunity, expired review.
· Give priority to approval services
· Classification definition service
· Innovative approval services
· Sign up for the cell partitioning service
· review and issue rectification services
· Review of remedial counseling services
Innovative medical devices
(1) Significance of special approval of innovative medical devices
Encourage research and innovation in medical devices
Promote the promotion and application of new medical device technologies
Promote the development of the medical device industry
(2) Relevant requirements for applying for special review of innovative medical devices
Through technological innovation activities, the applicant has a patent right for the invention of a key technology of the product in China, or transfers the patent right or the right to use the invention in China according to law; Or the application for a patent for a core technology invention shall be made public by the patent administration organ under The State Council.
The main working principle/mechanism of the product is technology leadership. Compared with similar products, the performance or safety of the product has been fundamentally improved, and it is in the international leading position in technology, and has significant clinical application value.
The applicant has completed a preliminary study of the product and has a basic finalized product. The research process is real and controllable, and the research data is complete and traceable.
(3) The benefits of applying for innovative medical device products
Initial intervention
Special person in charge
Inspection, system review, review priority
(4) Declaration process
