Medical device enterprises to report the first set of conditions to meet?

Medical device enterprises to declare the first set of the following conditions need to be met:

1. The application of the equipment belongs to the state has a special industry management requirements of the product (such as military, medical devices, measuring instruments, pressure vessels, etc.), you need to have the approval of the competent authorities of the relevant industries issued by the product production license.

2. The applicant is eligible, registered in Shandong Province administrative area for more than one year, with independent legal personality, standardized corporate governance structure, sound financial management system, no illegal business behavior in the past three years, no major accidents in quality, safety, and environmental protection, good financial condition of the enterprise, and high credit level.

3. High degree of product innovation, advanced technology. Apply for equipment through original innovation, comprehensive innovation or the introduction of technology digestion, absorption and re-innovation, in principle, structure, performance and other aspects of a major breakthrough, high technological content, high value of the equipment, driving role, high value-added, machine performance, key technologies and core indicators to reach the domestic leading or international advanced level of similar equipment. Application for equipment through the provincial departments, industry associations (associations) organized by the identification (acceptance) to determine the advanced nature of the product. By the professional new survey organizations to check the performance of the breakthrough, can support the conclusion of the new survey.

4. Products have independent intellectual property rights. Declare the name of the equipment should be clear and standardized, in line with relevant standards. Producers have independent intellectual property rights directly related to the declared equipment according to law, or transfer of intellectual property rights according to law.

5. Reliable product quality. Through the provincial quality and technical supervision departments accredited inspection agency or user-recognized inspection agency to test the performance indicators of the equipment. National special industry management requirements of the product, should hold the relevant industry authorities approved the issuance of the product production license; national implementation of mandatory product certification of the product, should be through mandatory product certification. Medical device products should also provide product technical requirements and full performance test report.

The above conditions for the declaration of the first set of basic conditions, specific reporting conditions may vary depending on the region and specific policies, it is recommended to consult the relevant local departments or professional organizations to obtain the latest policy information.