Medical network - on December 6, encourage medical equipment research and innovation, to promote the new technology popularization and application of medical equipment, the implementation of provincial service social investment one hundred big requirements of action, for the second type of innovation in our province medical apparatus and instruments for examination and approval of the "green channel", will be in the standard under the premise of not reduce, the program does not reduce, according to early intervention and assign special personnel to take charge of principle, scientific examination and approval, to conform to the special approval process of medical devices shall be preferred to deal with.
Provincial food drug administration recently issued the second innovation medical instrument special approval procedures (trial) ", to comply with the following situations at the same time medical apparatus and instruments according to the procedure of the implementation of special approval: (a) declare the product for the second category of medical devices, the applicant belongs to the jurisdiction of hainan province. (2) to declare one of products with the following intellectual property rights, or award that: national invention, progress prize in science and technology; Science and technology progress second prize at the provincial level or above; at least The core technology invention patent. (3) in the diagnosis or treatment of rare diseases, and has significant clinical advantage "to" declare products has significant clinical value, product technology for the domestic leading "and other circumstances. (4) the applicant has completed declaration in the early period of the product research and have basic finalize the design product, real and controlled the research process, research data integrity and traceable.
In accordance with the "procedures" requirement, after the applicant to apply for special approval, provincial food drug administration will issue examination opinions within 20 workdays, and the proposed special approval to apply for project to the public in its website.
The second category of medical devices
The state shall carry out the policy of classification administration of medical apparatus and instruments according to the degree of risk
The second category is a moderate risk, management must be strictly controlled to ensure its safe and effective medical devices |
