# Policy & Legal Basis
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.