What conditions should an enterprise dealing in medical devices have?

The qualifications required for operating medical devices are as follows:

1. To operate medical devices, a business license must be obtained according to law, and the business scope must include medical device sales;

2. There are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles recognized by the state;

3. Having business and storage places suitable for the business scope and scale;

4, with the scope and scale of business to adapt to the storage conditions, where entrusted to other medical device business enterprises can not set up a warehouse;

5. Having a quality management system suitable for operating medical devices;

6. Having professional guidance, technical training and after-sales service capabilities suitable for the medical devices operated, or agreeing to provide technical support from relevant institutions.

Legal basis: Article 9 of the Measures for the Supervision and Administration of Medical Device Operation.

To engage in business activities of medical devices, the following conditions shall be met:

(a) there are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles;

(2) A business place suitable for its business scope and scale;

(3) Storage conditions suitable for the business scope and scale;

(4) A quality management system suitable for the medical devices operated;

(five) quality management institutions or personnel with professional guidance, technical training and after-sales service suitable for the medical devices they operate.

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