Medical devices can be divided into three categories according to their degree of danger, and different types of medical devices need different certificates to operate. For example, to operate a class of medical devices, it is necessary to add corresponding business items to the company's business scope; To operate Class II medical devices, it is necessary to apply for the record certificate of Class II medical device operation; To operate three types of medical devices, it is necessary to obtain a medical device business license. Therefore, before the company is registered, we must first find out the types of medical devices we operate, so as not to get the wrong documents at that time.
Medical device company registration process:
Company registration must be verified first, and medical device companies are no exception. The company name is generally XX Medical Device Co., Ltd. (several company names can be prepared when verifying the company name to improve the passing rate of company name verification). After the name is approved, the examination and approval department will issue a notice of pre-approval of the name, then submit the registration materials and obtain the business license.
After obtaining the business license, you need to apply for the corresponding business license or business record. The treatment process is generally as follows:
1. Ensure that the company meets the bidding conditions and apply to the municipal food and drug supervision and administration department with districts. The bidding conditions here mean that the company has medical device-related business projects, quality management institutions or quality management personnel suitable for the business scope and scale, and business, storage places and quality management systems suitable for the medical devices it operates.
2. Submit the required information. The materials to be submitted include: enterprise name and business scope; Medical device product registration certificate, supplier's business license, license and authorization; Quality management documents; More than two medical or related professional certificates and identity certificates; Proof of office space and warehouse meeting the requirements of medical device operation, and other relevant materials required by the articles of association, resolutions of shareholders' meeting and laws and regulations.
3. Obtain a medical device business license. After the materials are submitted, the municipal food and drug supervision and administration department at the district level shall review the application materials within 30 working days from the date of acceptance, and conduct on-site verification in accordance with the requirements of the Quality Management Standard for Medical Device Operation (if rectification is needed, the rectification time shall not be included in the audit time limit). If the requirements are met, the regulatory authorities will issue the Business License for Enterprise Medical Devices or the Record Certificate for Class II Medical Devices within 10 working days.