I deal in Class I medical devices. How do I apply for Class II medical devices?

regulations vary from place to place. Generally speaking, it is this provision. 1. Policies, laws and regulations are based on the Measures for the Supervision and Administration of Medical Device Production (Order No.18 of National Medical Products Administration) and the Measures for the Supervision and Administration of Medical Device Trading Enterprises (Order No.19 of National Medical Products Administration). 2. Information to be provided The applicant should apply to the local drug administration, fill in the Application Form for the License of Medical Device Production (Trading) Enterprise (hereinafter referred to as the Application Form), and submit the following information: (1) (two) the person in charge of the enterprise, the person in charge of the quality inspection agency and other technical personnel's academic qualifications or professional titles (provided by the second type of medical device production and operation enterprises); (three) a copy of the qualification certificate of the full-time quality inspection personnel of the enterprise (provided by the second kind of medical device production and operation enterprises); (4) Proof of production (operation) site (copy of property right certificate or lease contract, provided by the second-class medical device production and operation enterprise); (5) A self-assurance statement on the authenticity of the materials submitted by the enterprise. Iii. Procedures and time limit for handling (1) After receiving the application for the license to start the first and second types of medical device production (operation) enterprises, the county (city, district) drug administration shall fill in the Acceptance Review Opinion (hereinafter referred to as the Opinion), put forward the preliminary examination opinion, and report the applicant's Application Form and Opinion to the municipal (city divided into districts) drug administration within seven working days. (2) After receiving the Application Form and Opinion, the Municipal Drug Administration shall organize the preliminary examination, inspection and acceptance, put forward the review opinions, and report the Application Form and Opinion to the drug administration of the autonomous region within ten working days. (3) The drug administration of the autonomous region shall, within fifteen working days after receiving the Application Form and the Opinion, make a decision on whether to file or issue certificates, and shall explain the reasons in writing if it does not file or issue certificates. Iv. responsible office: medical device office