Legal analysis: the operation of Class II medical devices, business enterprises need to the local food and drug regulatory departments for the record. For the record need to submit the following information :1, the second class of medical devices business filing form; 2, a copy of the business license; 3, the legal representative or person in charge of the enterprise, the person in charge of quality, the person in charge of quality institutions or full-time quality management personnel, maintenance, after-sales service, technology and other personnel ID card, education, title certificate copies.
Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 11 Application for registration of Class II medical device products, the applicant for registration shall be located in the provinces, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department shall submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit an application for registration to the State Council Food and Drug Administration. To China's exports of Class II, Class III medical devices overseas manufacturers, should be set up in China's territory by its representative body or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the application for registration information and registration of the applicant's country (region) competent authorities to permit the marketing of the medical device documents. Class II, Class III medical device product registration application information in the product inspection report shall be a medical device inspection agency issued the inspection report; clinical evaluation information shall include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.