# Policy & Legal Basis

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

An enterprise engaging in online sale of medical devices shall carry out online sale of medical devices through its own website or a third-party platform for online trading services for medical devices. An enterprise engaging in online sale of medical devices through its own website shall obtain the Qualification Certificate for Internet Drug Information Services in accordance with the law, and have office premises, data backup, failure recovery and other technical conditions commensurate with its size.

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

To establish an enterprise engaging in the production of Class II or Class III medical devices, the applicant shall file an application for production licensing with the local food and drug administration of the province, autonomous region or municipality directly under the Central Government.

Article 10 If the prescribed conditions are met, the food and drug administration shall make a written decision to approve licensing in accordance with law, and issue the Medical Device Production License within 10 working days; and if the prescribed conditions are not met, shall make a written disapproval decision, and give an explanation on reasons.

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

To engage in business activities involving Class III medical devices, an enterprise shall apply for a business license to the food and drug administration of the people’s government at the level of the districted city at the place where it is located.