Medical device license refers to the government agencies in accordance with the "Regulations on the Administration of Medical Devices" issued by the government agencies, allowing enterprises to produce and operate medical devices certificate. Enterprises that obtain a medical device license can legally produce and operate medical devices.
Enterprises obtaining a medical device license need to meet the following requirements:
1. Enterprises must have legal business qualifications, including business license, tax registration certificate, food circulation license, medical device license, etc.;
2. Enterprises must have good production facilities, including plants, workshops, warehouses, testing rooms, etc.;
3, the enterprise must have a good production management system, including quality management system, production management system, quality control system, etc.;
4, the enterprise must have good technical conditions, including equipment, technology, personnel, etc.;
5, the enterprise must have sufficient quality control capabilities, including quality control system, testing capabilities, quality management system, etc.;
6, the enterprise must have a perfect quality management system, including quality management system, quality control system, quality testing system, etc.;
7, the enterprise must have a perfect quality testing system, including quality testing equipment, testing methods, testing standards, etc..
The above is the basic requirements for obtaining a medical device license, companies need to follow these requirements, improve their own management system, in order to obtain a license.