The first thing you need to do is to check the name of the company, medical equipment companies are of course no exception, the name of the company is generally XX Medical Devices Ltd (check the name of the company can be more than a few company names, in order to improve the company's check the name of the pass 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). If the conditions are met, the regulatory department will issue the medical device license or Class II medical device business filing voucher to the enterprise within 10 working days