1. Application materials for medical devices
1 Submit the application form for medical device enterprise license (in duplicate)
1. 1 First check the name, that is, the enterprise name must be approved in advance.
1.2 The registered address and warehouse address of the enterprise must be filled in according to the relevant documents such as the house property right certificate or the use certificate.
1.3 the business scope of the enterprise must be filled in according to the actual situation of the enterprise and checked with the medical device classification catalogue.
2. Certificate of house use right or property right
If the enterprise's registered address, registered warehouse address lease or property rights are complicated, relevant supporting documents of joint relationship shall be provided.
List of technical personnel and copies of relevant graduation certificates and professional title certificates.
3. 1 The list of technical personnel must be filled in according to the requirements of the corresponding technical personnel required by the enterprise to declare its business scope.
3.2 All technical personnel's academic qualifications and professional title certificates must be copied, and no omission is allowed.
4. Plan of business premises and warehouse
4. 1 First of all, the plan should be clearly marked.
4.2 All departments of the enterprise must indicate on the floor plan of the business premises, and the floor plan of the warehouse must indicate the partition area and specific area.
5 specification for submission of application materials
All application materials must be printed or copied on A4 paper, stamped with the official seal or signed by the legal representative. If the newly applied enterprise does not have a company seal, the application materials must be signed by the legal representative of the enterprise.
Matters needing attention in on-site acceptance of medical devices
2. 1 Before submitting the application materials, the enterprise must make full preparations according to the specific requirements of the Code for Site Acceptance of Medical Device Enterprises.
2.2 On the day of on-site inspection, relevant technical personnel, such as the person in charge of the enterprise and the quality administrator, must go to the site.
The above are the precautions for handling the conditions of Shanghai medical device business license. In the process of handling these medical devices, bosses should know the relevant information in advance in order to successfully review them better and faster.