Since June 1, 2014, engaged in the second class of medical equipment business, business enterprises should fill out the second class of medical equipment business filing form to the location of the municipal food and drug supervision and management department for the record, and submit the filing materials in line with the requirements of the filing of the second class of medical equipment business filing materials.
Receiving medical device business filing materials, the municipal food and drug supervision and management department should be field on the integrity of the filing materials for verification, in line with the prescribed conditions to be filed, issued by the second class of medical equipment business filing vouchers.
The second class of medical equipment business filing vouchers for the record number numbering rules for: XX food and drug supervision and mechanical business XXXXXXXXXX. Where: the first X on behalf of the record department of the province, autonomous region, municipality directly under the Central Government of the Chinese abbreviation, the second X on behalf of the location of the municipal administrative region of the Chinese abbreviation, the third to the six X on behalf of the 4-digit year of filing, the seventh to the tenth X on behalf of the 4-digit number of filing water number.
Extended information
Application for registration of Class II medical device products, the applicant for registration shall submit the registration application information to the food and drug administration department of the people's government of the province, autonomous region and municipality directly under the central government. Apply for registration of Class III medical device products, the applicant shall submit to the State Council food and drug supervision and management department of the registration application information.
To China's exports of Class II, Class III medical devices overseas manufacturers, should be set up by its representative office 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 the registration of the applicant's country (region) the competent authorities to permit the marketing of the medical device documents.
The second class, the third class of medical device product registration application information in the product inspection report should be a medical device inspection agency issued the inspection report; clinical evaluation information should include clinical trial report.
Baidu Encyclopedia - Class II Medical Device Business Record
Baidu Encyclopedia - Medical Device Supervision and Administration Regulations