With the ravages of the epidemic, the global demand for medical equipment continues to climb, all for the need to buy and sell medical equipment entrepreneurs, apply for a medical device license is imminent, registered medical device company compared to ordinary company registration is more difficult, because it involves medical and health care, the Business and Industry Bureau for approval of the more stringent, so many entrepreneurs have been stuck in the company registration, Xiaobian to you to sort out the A related information for your reference.
Medical device company registration conditions
1. The company needs to have with the scope of business and business scale of the quality management institutions or quality management personnel, quality management personnel should have nationally recognized relevant professional qualifications or titles. It should be noted that, in addition to the operation of three types of medical devices enterprise quality person in charge of the relevant professional qualifications or titles, should also have more than three years of medical device business quality management experience;
2. With the scope of business and the scale of operation of the business, storage space. For example, the operation of three or two types of in vitro diagnostic reagents, the use of business premises shall not be less than 100 square meters, the use of storage area shall not be less than 60 square meters, the cold storage volume shall not be less than 20 cubic meters, etc. (different areas of different policy requirements). All entrusted to other medical device business enterprise storage company, can also not set up a warehouse;
3. With the operation of medical devices compatible with the quality management system;
4. With the operation of medical devices compatible with the professional guidance, technical training and after-sales service capacity, or agreed to by the relevant organizations to provide technical support. And engaged in the third class of medical devices business enterprises, in addition to these, should also have to meet the quality management requirements of medical devices business computer software management system to ensure that the operation of the product traceability, these are the basic conditions.
5, the person in charge of the company and quality management personnel to interview, the Food and Drug Administration to conduct a basic understanding of the enterprise.
Medical device company registration process
Process 1: The founders need to go to the business administration department to deal with the pre-approval notice of the company name.
Process 2: To register a medical device company you need to submit online application materials to the local Food and Drug Administration website.
Process 3: Once the founder's online material review is approved, the local drug regulatory authority will schedule an appointment to view the business site.
Process 4: The founders submit written application materials, and once approved, a medical device business license will be issued.
Process 5: founders to open a capital verification account, shareholder contributions, accounting services related to capital verification report.
Process 6: founders apply for a business license.
Process 7: go to carve the company required seal, ready for business.
Process 8: Transfer to the relevant departments to deal with the organization code certificate.
Process 9: The person who registers the medical device company goes to the relevant department to apply for the tax registration certificate.
Materials required for registration of medical device company
1, business name and scope of business, registered capital and shareholders' contribution ratio, shareholders and other proof of identity;
2, certificate of registration of medical device products, suppliers' business licenses, permits and authorizations;
3, quality management documents and so on;
4, two or more medical professional or related professional certificates, identification and resume;
5, meet the requirements of the medical device business office space and warehouse certificate;
6, articles of incorporation, shareholders' meeting resolution, etc.;
7, the financial personnel ID card and induction certificate;
8, other related materials;
Processing of the "Medical Device Business License" and company Registration time in 15 working days.