Medical device business enterprises should meet the conditions Come to understand it!

1, 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.

2, with the scale and scope of operation of relatively independent business premises.

3, with the scale and scope of operation of the storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical devices.

4, should establish and improve the 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 its business with the medical device products compatible with the technical training and after-sales service capabilities, or agreed to provide technical support by a third party.

6, the application for "medical device business enterprise license", must pass the (food) drug supervision and management department's inspection and acceptance.

7, "Medical Device Business License" set out the business scope should be in accordance with the medical device classification directory of the management category, class code name to determine.