Registration conditions of medical device companies
1. The company shall have quality management institutions or quality management personnel suitable for its business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles recognized by the state. It should be noted that, in addition to relevant professional qualifications or titles, the quality leaders of the three types of medical device enterprises should also have more than 3 years of experience in quality management of medical device operation;
2. Having business and storage places suitable for the business scope and scale. If the third or second kind of in-vitro diagnostic reagents are operated, the use area of the business premises shall not be less than 100 square meters, the use area of the warehouse shall not be less than 60 square meters, and the volume of the cold storage shall not be less than 20 cubic meters (different policy requirements in different regions). A company that entrusts all other medical device storage enterprises shall not set up warehouses;
3. It has a quality management system suitable for the medical devices it operates;
4. Having the professional guidance, technical training and after-sales service capabilities suitable for the medical devices operated, or agreeing to provide technical support from relevant institutions. In addition to these, enterprises engaged in the management of the third kind of medical devices should also have a computer software management system that meets the requirements of the quality management of medical devices to ensure the traceability of the products they operate. These are the basic conditions.
5. Interview the person in charge of the company and quality management personnel, and the Food and Drug Administration should have a basic understanding of the enterprise.
Medical device company registration process
Process 1: The founder needs to go to the administrative department for industry and commerce to handle the company name pre-approval notice.
Process 2: Registered medical device enterprises need to submit online application materials to the website of the local Food and Drug Administration.
Process 3: After the founder's online materials are approved, the local drug supervision department will make an appointment to inspect the business premises.
Process 4: The founder submits written application materials, and once approved, the medical device enterprise license is issued.
Process 5: the founder opens a capital verification account, the shareholders contribute capital, and the accountant affairs related capital verification report.
Process 6: The founder applies for a business license.
Process 7: Carve the seal needed by the company and get ready for business.
Process 8: Go to the relevant departments for the organization code certificate.
Process 9: Registered medical device company personnel apply for tax registration certificate in relevant departments.
Materials required for registration of medical device companies
1, name and business scope of the enterprise, registered capital and proportion of shareholders' contribution, and identification of shareholders;
2, medical device product registration certificate, supplier business license, license and authorization;
3. Quality management documents, etc.
4. Certificates, identity certificates and resumes of two or more medical professionals or related professionals;
5, in line with the requirements of medical equipment business office space and warehouse proof;
6. Articles of Association, resolutions of shareholders' meeting, etc.
7. ID card and employment certificate of financial personnel;
8. Other relevant materials;
It takes 15 working days to apply for a medical device business license and register a company.