What conditions do medical device enterprises need to meet when applying for the first set?

Medical device enterprises must meet the following conditions to declare the first set:

1. The equipment applied for belongs to products with special industry management requirements (such as military industry, medical instruments, measuring instruments, pressure vessels, etc.). ), and it is necessary to have a product production license approved by the relevant industry authorities.

2. The applicant meets the requirements, has been registered in the administrative area of Shandong Province for more than one year, has the qualification of an independent legal person, has a standardized corporate governance structure, has a sound financial management system, has no illegal business practices in the past three years, has no major quality, safety and environmental accidents, has a good financial situation and has a high credit rating.

3. High degree of product innovation and advanced technology. Through original innovation, comprehensive innovation or re-innovation by introducing technology, the application equipment has made a major breakthrough in principle, structure and performance, with high technical content, great equipment value, strong driving effect and high added value. The performance, key technologies and core indicators of the whole machine have reached the domestic or international advanced level of similar equipment. The advanced nature of products is determined by the appraisal (acceptance) organized by departments at or above the provincial level and industry associations. The new findings can be supported by the performance breakthrough of professional new investigation institutions.

4. The product has independent intellectual property rights. The name of the declared equipment shall be clear and standardized, and conform to the relevant standards. Production enterprises have independent intellectual property rights directly related to the declared equipment according to law, or transfer intellectual property rights according to law.

5. The product quality is reliable. Equipment performance indicators should be inspected by the quality and technical supervision departments at or above the provincial level, the qualification certification and inspection institutions or the inspection institutions recognized by users. Products required by the national special industry management shall hold the product production license approved and issued by the relevant industry authorities; Products subject to compulsory product certification by the state shall pass the compulsory product certification. Medical device products should also provide product technical requirements and complete performance test reports.

The above conditions are the basic conditions for applying for the first set, and the specific application conditions may change due to different regions and specific policies. It is recommended to consult relevant local departments or professional institutions to obtain the latest policy information.