Legal analysis: to export to China's territory of the second class, the third class of medical devices overseas production enterprises, should be set up by its representative body in China or designate China's territory of the enterprise as an agent of the State Council food and drug supervision and management department submitted to the registration of the applicant for registration information and registration applicant's country (region) competent authorities to authorize the sale of the medical device on the market documents.
Legal basis: "Chinese People's **** and the State Medical Device Supervision and Administration Regulations" Article 10 of the first class of medical equipment products for the record, by the filing to the municipal people's government of the location of food and drug supervision and management department to submit the record information. Among them, the product inspection report can be the filer's self-inspection report; clinical evaluation information does not include clinical trial report, can be through the literature, the data obtained from the clinical use of similar products to prove that the medical device is safe and effective information. To China's exports of Class I medical devices overseas manufacturers, 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 filing information and the filer's country (region) competent authorities to authorize the marketing of the medical device documents.