1. There are quality management institutions or full-time quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional qualifications or titles recognized by the state;
(2) Having a relatively independent business place suitable for its business scale and scope;
3. Having storage conditions suitable for the business scale and scope, including storage facilities and equipment that meet the requirements of medical device products;
Four, should establish and improve the product quality management system, including procurement, incoming inspection, warehousing, outbound review, quality tracking system and adverse event reporting system;
Five, it should have the technical training and after-sales service ability suitable for the medical device products it deals in, or agree to provide technical support by a third party.
Handling method: The (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the proposed enterprise is located or the entrusted (food) drug supervision and administration institution of the city divided into districts is responsible for accepting and issuing the application for the Medical Device Business License.
Extended data
The main contents of supervision and inspection include:
1. Change of enterprise name, legal representative or person in charge of the enterprise and quality management personnel.
2. Change of registered address and warehouse address of the enterprise.
3, business premises, storage conditions and main storage facilities and equipment.
4. Implementation and change of important matters such as business scope.
5, the implementation of enterprise product quality management system.
6. Other related matters that need to be checked.
Baidu Encyclopedia-Medical Device Business License