1, licensing procedures (a) registration application. Registered applicants in accordance with the requirements of the pilot, their own production of samples and declare the registration of Class II medical devices, the provincial bureau of the organization's registration quality management system verification. Commissioned by the province or the pilot province (city) with the appropriate medical device production conditions of enterprises to produce samples and declare the second class of medical devices registered by the Provincial Bureau according to the registration declaration information, commissioning contracts and quality agreements and other relevant evidence of the conditions of the registrant and commissioned the production of enterprise conditions of the material, the organization of the commissioned production of quality management system and production capacity of the quality management system and verification of the quality management system for the registration of production enterprises.
2, production license application. Registrants need to apply for a production license after obtaining a medical device registration certificate for their own production, in accordance with the "supervision and management of the production of medical devices" to apply for a medical device production license, eligible for issuance of production licenses.