# Policy and Regulation Basis

Article 24 of the Regulations on the Administration of Medical Institutions

No entity or individual may carry out diagnosis and treatment activities without obtaining the Practicing License for Medical Institutions.

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.

# Examples of Qualifications

Medical Institution Practice License:

Medical Device Production License:

Supplier Medical Device Record Certificate: