# Policy and Regulation Basis
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.