With the development of the medical device industry, and the improvement of people's health consciousness, more and more medical device-based companies appear in people's sight. So for entrepreneurs, how should they register a company that focuses on medical device business? The next step is to take a look at it with the editor.
Medical devices can be divided into three categories according to their degree of risk, and different types of medical equipment business requires different documents. For example, a class of medical devices, you need to add the appropriate business items in the company's scope of business; operating class II medical devices, you need to apply for class II medical device business record certificate; operating class III medical devices, you need to obtain a medical device business license. Therefore, before the registration of the company first of all to figure out how many classes of medical equipment, so as not to do the wrong documents.
Medical equipment company registration process:
Company registration first to the name, of course, medical equipment companies are no exception, the company name is generally XX Medical Devices Limited (the name can be more than a couple of company name, in order to improve the company's nuclear name through the rate). After the name is approved, the approval department will issue a name pre-approval notice, and then submit the registration materials to receive a business license.
After receiving the business license, you need to apply for the appropriate business license or business record. The process is generally as follows:
1. Ensure that the company meets the application conditions, and to the location of the municipal food and drug supervision and management department to apply for. Here the bidding conditions refers to the company has a medical device-related business projects, and has a business scope and scale of operation of the quality management organization or quality management personnel, as well as with the business scope and scale of operation of the business, storage space and the operation of medical devices to adapt to the quality of the management system and so on.
2. Submit the required information. The information required to be submitted include: business name and scope of business; medical device product registration certificate, supplier business license, permit and authorization; quality management documents; two or more medical professionals or related professional certificates and identification; meet the requirements of medical equipment business office space and warehouse certificate, as well as the articles of association, shareholders' resolutions and laws and regulations required to be submitted to the other relevant material etc.
3. Receive medical device license. After submitting the materials, the municipal food and drug supervision and management department will review the application information within 30 working days from the date of acceptance, and carry out on-site verification in accordance with the requirements of the Code of Practice for the Quality Management of Medical Devices Businesses (if rectification is required, the time for rectification will not be counted as part of the time limit for review). Meet the prescribed conditions, the regulatory authorities will be issued within 10 working days to the enterprise medical device business license or Class II medical device business filing vouchers.