One, with the business scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles;
Two, with the business scope and scale of operation of the business, storage space;
Three, with the business scope and scale of operation of the storage conditions, all Commissioned other medical device business enterprise storage can not set up a warehouse;
Four, with the operation of medical devices appropriate quality management system;
Five, with the operation of medical devices appropriate professional guidance, technical training and after-sales service capacity, or agreed to provide technical support by the relevant organizations.
Enterprises engaged in the operation of Class III medical devices should also have a computer information management system that meets the requirements of quality management of medical device business, to ensure that the operation of the product can be traced.
Expanded Information
Application for Class III medical device list of materials required:
1, business license, organization code certificate copy.
2, the applicant company holds a copy of the registration certificate of the medical device produced and product technical requirements.?
3, legal representative, the person in charge of the enterprise a copy of identification.
4, production, quality and technical personnel in charge of the identity, education, title certificate copies.
5, production management, quality inspection position practitioners education, title list.
6, the production site documents, there are special production environment requirements should also be submitted to the facilities, environment, copies of documents.
7, the main production equipment and inspection equipment catalog.
8, quality manual and program documents.
9, process flow diagram.
10, the operator's authorization certificate.
11, other supporting information.
Baidu Encyclopedia - Medical Device Management Supervision and Administration
Baidu Encyclopedia - Class III Medical Devices