Companies engaged in the operation of medical devices must meet certain conditions in order to obtain a license to operate. First, the company needs to have a quality management organization or quality management personnel that matches its business scope and scale, and these personnel should have nationally recognized relevant professional qualifications or titles; second, the company must have a business and storage space that is adapted to its business scope and scale. For Class II medical device business enterprises, they need to be filed with the provincial or equivalent level drug supervision and management department; while to start a Class III medical device business enterprise, it needs to be examined and approved by the provincial drug supervision and management department and issued with a "Medical Device Business Enterprise License".
Device company's business scope:
1, medical device sales;
2, medical device repair services;
3, medical device technology consulting;
4, medical device leasing services;
5, medical device import and export business.
In summary, companies engaged in the medical device business must meet specific conditions in order to obtain a license to operate, including having a quality management institutions or personnel to match the scope and scale of business, have a place to adapt to the operation and storage, and according to the different categories of enterprises need to be filed or reviewed and approved to obtain a license.
Legal basis:
Methods for the Administration of Medical Device Business License
Article VI
Application for a "medical device business license" shall have the following conditions:
Have a quality management organization or full-time quality management personnel to match the scale of operation and scope of business. Quality management personnel should have a nationally recognized professional qualifications or titles;
with the scale and scope of operation of relatively independent premises;
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;
should be established and sound product quality
Should establish a sound 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;
Should have the appropriate technical training and after-sales service capabilities of its medical device products, or agreed to provide technical support by a third party.