More information about registering a medical instrument company in Shanghai, welcome to consult: 18101649652/021-58763186-8008
With the global diffusion of coronavirus, the lack of medical supplies is serious. As a superpower, although China donates a lot of materials to many countries, the shortage of medical supplies still exists, and may be in short supply for a long time. More and more investors want to develop the field of medical equipments, and the first step is to register a medical equipment company, then how to register? What are the conditions that need to be met?
The Conditions that Medical Device Company Registration Needs to Meet
1.The company shall have a quality management organization or quality management personnel that matches its business scope and business scale, and the quality management personnel shall have relevant academic degrees or professional titles recognized by the state. It should be noted that, in addition to the relevant professional education or title, the quality manager of the Class III medical device enterprises should also have more than three years of medical device quality management experience;
2.There are operation and storage sites suitable for the business scope and scale. For example, the business area of Class III or Class II in vitro diagnostic reagents shall not be less than 100 square meters, the storage area shall not be less than 60 square meters, and the cold storage volume shall not be less than 20 cubic meters, etc. (policy requirements vary in different regions). Companies that entrust all other medical device trading enterprises with storage is not necessary to set up warehouses;
3.Quality management system suitable for medical devices;
4.Have the ability to provide professional guidance, technical training and after-sales service in accordance with the medical devices they operate, or appoint relevant institutions to provide technical support. Except these, enterprises engaged in the operation of Class III medical devices shall have a computer information management system that meets the requirements of quality management of medical device operation to ensure the traceability of products.
Medical Device Company Registration Process
1. Go to the Industrial and Commercial Bureau to get the "Enterprise Name Pre-Approval Notice"
2. All investors sign industrial and commercial materials
3. Apply for business license
4. Seals
5. Apply for organization code certificate
6. Apply for tax registration certificate
7. Submit online application materials on the website of Shanghai Food and Drug Administration
8. After the online materials are approved, the Food and Drug Administration will make an appointment and inspect the business site
9. Submit written application materials and issue Medical Device Business Enterprise License after approval.
Materials Required for Registration of Medical Device Company
1. Enterprise name and business scope, registered capital and proportion of shareholders' investment, shareholders' identity certificates
2. Medical device product registration certificate, manufacturing enterprise license, business license and authorization letter
3. Quality management documents, etc
4. At least 3 medical professional or related professional certificate, identification certificate and resume
5. Office space and warehouse in accordance with the requirements of medical devices and relevant certification documents (Tannet can provide)
Notice of Shanghai Medical Device Company Registration
1. The registered address must be a formal office building, and reach a certain square, residential cannot be used for the registration of the company;
2. The company's business scope of Category 2 and Category 3 medical devices is subject to administrative approval, and medical device business license is required;
3. There must be 3 people with medical school qualification certificate for the record;
4. If registering foreign trade company, after the completion of the company registration, also need to go through the import and export
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