According to the relevant regulations, medical device manufacturers do not need to apply for business license or filing to sell medical devices at their production addresses; Where medical devices are stored or sold in different places, the business license or filing shall be handled in accordance with the provisions.

Qualifications required to operate medical devices:

1. 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;

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

3, 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;

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

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

To sum up, the operation of medical devices requires the company to implement classified management according to the risk degree of medical devices.

Legal basis:

Article 30 of the Regulations on the Supervision and Administration of Medical Devices

Engaged in medical device production activities, shall meet the following conditions:

(1) Having a production site, environmental conditions, production equipment and professional technicians suitable for the medical devices produced;

(2) Having institutions or full-time inspectors and inspection equipment capable of conducting quality inspection on the medical devices produced;

(3) Having a management system to ensure the quality of medical devices;

(4) Having the ability of after-sales service suitable for the medical devices produced;

(five) meet the requirements of product development and production process documents.