According to the relevant provisions of the medical device manufacturer in its production address sales of medical devices, do not need to apply for a business license or record; in other places of storage and spot sales of medical devices, should be in accordance with the provisions of the business license or record.
Medical device business qualifications:
1, 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 professional qualifications or titles;
2, with the business scope and scale of operation of the operation and storage space;
3, with the With the business scope and scale of operation of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
4, with the operation of medical devices appropriate quality management system;
5, 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.
6.
In summary, the operation of medical devices, the need for corporate nature of the enterprise, according to the degree of risk of medical devices, medical device business implementation of classification and management.
Legal basis:
"Supervision and Administration of Medical Devices Regulations" Article 30
Engaged in the production of medical devices, should have the following conditions:
(a) with the production of medical devices compatible with the production site, environmental conditions, production equipment, as well as professional and technical personnel;
(b) there can be the production of medical devices to carry out (B) the production of medical devices can be quality inspection organizations or full-time inspectors and inspection equipment;
(C) to ensure that the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the requirements of product development, production process documentation.