Announcement on Matters Relating to the Recordation of Medical Device Manufacturing and Operation
The new The revised Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) came into force on June 1, 2014. Now the first class medical device production and the second class medical device business filing related matters are announced as follows: First, the first class medical device production filing (a) since June 1, 2014, engaged in the production of Class I medical devices, the manufacturer should fill out the first class medical device production filing form (see piece 1), to the location of the municipal food and drug supervision and management department for the record and submit a report in line with the first class medical device production filing form (see pieces of 1), to the municipal food and drug supervision and management department for the record and to submit a report in line with the first class medical device production filing form. Submitted in line with the requirements of the first class of medical devices production filing materials (see Part 2) of the record materials. Receive the first class of medical devices production record material of the municipal food and drug supervision and management departments should be field on the integrity of the record material to check, meet the conditions to be filed, issued by the first class of medical devices production record voucher (see piece 3). The first class of medical devices production record vouchers for the record number numbering rules: XX food and drug supervision and production of mechanical XXXXXXXXXXX number. Among them: the first X on behalf of the record department where the province, autonomous regions, municipalities directly under the Central Chinese abbreviation, the second X on behalf of the location of the municipal administrative region of the Chinese abbreviation, the third to six X on behalf of the 4-digit year of filing, the seventh to ten X on behalf of the 4-digit number of the record running number. (ii) June 1, 2014, the manufacturer has been to the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration for the first class of medical devices manufacturer registration, registration information continues to be valid, no need to re-apply for the record. Second, the second class of medical devices for the record (a) Since June 1, 2014, engaged in the second class of medical equipment business, business enterprises should fill out the second class of medical devices for the record (see Figure 4), to the location of the municipal food and drug supervision and management departments for the record, and submit to comply with the requirements of the second class of medical devices for the record (see Figure 5) of the record materials. Receive medical device business filing materials of the municipal food and drug supervision and management departments should be field on the integrity of the filing materials to verify that meet the prescribed conditions to be filed, issued by the second class of medical equipment business filing vouchers (see piece 6). The second class of medical equipment business record vouchers for the record number numbering rules: XX food and drug supervision and mechanical business XXXXXXXXXX. Among them: the first X on behalf of the record department where the province, autonomous regions, municipalities 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 six X on behalf of the 4-digit filing year, the seventh to ten X on behalf of the 4-digit filing number. (ii) June 1, 2014 has been obtained before the second class of medical devices business license, do not need to re-apply for the record. The expiration of the business license to continue to engage in business, should be filed. June 1, 2014 has been accepted before the second class of medical devices business license application, acceptance of the food and drug supervision and management departments to notify the enterprise in accordance with the new provisions for the record. (C) operating "on the publication of the first batch do not need to apply for" medical equipment business license "of the second class of medical equipment product directory notice" (State Food and Drug Administration City [2005] 239) and "on the publication of the second batch do not need to apply for" medical equipment business license "of the second class of medical equipment product directory notice" (State Food and Drug Administration arm 〔2011〕 462) directory of the Medical device business enterprises should apply for the record. The announcement is hereby made.