(2) Having a business and storage place suitable for the business scope and scale;
Three, with the business scope and scale of storage conditions, where entrusted to other medical device business enterprises can not set up a warehouse;
(4) Having a quality management system suitable for operating medical devices;
Five, have the ability of professional guidance, technical training and after-sales service to adapt to the medical device business, or agree to provide technical support by relevant institutions.
Enterprises engaged in the operation of third-class medical devices should also have computer information management systems that meet the requirements of medical device operation quality management to ensure the traceability of the products they operate.
Extended data
List of materials required to apply for Class III medical devices:
1. Copy of business license and organization code certificate.
2 copies of the registration certificate and product technical requirements of the medical devices produced by the applicant enterprise. ?
3, the legal representative, the person in charge of the enterprise identity certificate copy.
4, production, quality and technology responsible person's identity, education, title certificate copy.
5. List of production management, quality inspection posts and professional qualifications.
6, production site documents, there are special production environment requirements, should also be submitted to the facilities, environmental documents copy.
7, the main production equipment and inspection equipment directory.
8, quality manual and program files.
9. Process flow chart.
10, agent authorization certificate.
1 1, other supporting documents.
Baidu Encyclopedia-Measures for the Supervision and Administration of Medical Device Management
Baidu encyclopedia-three kinds of medical devices