Conditions for application:
One, with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles;
Two, with the scale and scope of operation of relatively independent premises;
Three, with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;
Directly. Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
5, should have the appropriate technical training and after-sales service with its business medical device products, or agreed by the third party to provide technical support.
Handling method: the proposed enterprise location of provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration or accept the entrusted municipal (food) drug supervision and management agencies responsible for accepting the "Medical Device Business License" application for licensing.
Extended information
The main contents of the supervision and inspection include:
1, the name of the enterprise, the enterprise's legal representative or person in charge of the changes in quality management personnel.
2, the enterprise registered address and warehouse address changes.
3, business premises, storage conditions and the main storage facilities, equipment.
4, business scope and other important matters of implementation and changes.
5, the implementation of enterprise product quality management system.
6, other relevant matters needing inspection.
Baidu Encyclopedia - Medical Device Business License