# Policy and Regulation Basis

Article 9 of the Measures for the Supervision and Administration of Online Sales of Medical Devices

Enterprises engaged in online sales of medical devices shall carry out online sales activities of medical devices through self-built websites or third-party platforms for medical device online trading services. Enterprises that carry out online sales of medical devices through self-built websites shall obtain the Internet Drug Information Service Qualification Certificate in accordance with the law, and have the office space and technical conditions such as data backup and fault recovery commensurate with their scale.

1. Article 8 of the Measures for the Supervision and Administration of Medical Device Production

To establish a Class II or Class III medical device manufacturing enterprise, an application for a production license shall be filed with the local food and drug administration of the province, autonomous region or municipality directly under the Central Government.

Article 10 If it meets the prescribed conditions, it shall make a written decision to approve the license according to law, and issue the Medical Device Production License within 10 working days.If the prescribed conditions are not met, a written decision of disapproval shall be made and the reasons shall be given.

2. Article 31 of the Regulation on the Supervision and Administration of Medical Devices

To engage in the distribution of Class III medical devices, the operating enterprise shall apply to the food and drug administration department of the local people's government at the districted city level for a business license.

# Examples of Qualifications

Internet Drug Information Service Qualification Certificate:

Medical Device Production License:

Medical Device Business License: