A, "supervision and management of medical devices regulations" (State Council Decree No. 650) Article 11: Apply 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 to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit the registration application information 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 by its representative body in China 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 authorize the sale of the medical devices on the market 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.
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