Notice concerning the filing

　　The newly revised regulations on the supervision and administration of medical devices (order no. 650 of the state council) shall come into force as of June 1, 2014.The relevant issues concerning the filing of the production of the first type of medical devices and the operation of the second type of medical devices are hereby announced as follows:

• I. record of the production of the first type of medical devices

　　(a) from June 1, 2014, is engaged in production of class I medical devices, production enterprise shall fill in the class I medical devices production application form (see appendix 1), to the local food and drug supervision and administration department for the record, the level of district-constituted municipalities and submitted to comply with the requirement of class I medical devices production record filing materials (see attachment 2) record filing materials.

　　The record number of the record number of the certificate for the production record of the first class of medical devices is stipulated as follows: no. XXXXXXXX for the production of pesticide.Where: the first X stands for the Chinese abbreviation of the province, autonomous region and municipality where the filing department is located, the second X stands for the Chinese abbreviation of the municipal administrative region where the district is located, the third to the sixth X stands for the four-digit record year, and the seventh to the tenth X stands for the four-digit record serial number.

　(2) before June 1, 2014, if the production enterprise has already registered with the food and drug administration department of the province, autonomous region or municipality directly under the central government, the registration information shall remain valid and need not be re-filed.

　　

• Ii. Medical devices of the second type shall be put on record

　(a) from June 1, 2014, is engaged in the second category of medical equipment management, enterprise should fill in the second category of medical equipment management application form (see annex 4), to the local food and drug supervision and administration department for the record, the level of district-constituted municipalities and submitted to comply with the requirement of the second category of medical equipment management record filing materials (see annex 5) record filing materials.

　

The municipal food and drug supervision and administration department of the district where the receiving medical device business is registered shall check the integrity of the record material on site, put it on record if it meets the specified conditions, and issue the certificate for the record of the second class medical device business (see annex 6).

The number of the record number of the record number of the second type of medical device business record certificate is: XX food and drug ordnance business supplies XXXXXXXX.Where: the first X stands for the Chinese abbreviation of the province, autonomous region and municipality where the filing department is located, the second X stands for the Chinese abbreviation of the municipal administrative region where the district is located, the third to the sixth X stands for the four-digit record year, and the seventh to the tenth X stands for the four-digit record serial number.

　　(3) operating on the released the first batch of don't need to apply for the medical device operation enterprise licence > notice of the second category of medical equipment products list (the food drug safety city [2005] no. 239) and "about the second batch of do not need to apply for the medical device operation enterprise licence > notice of the second category of medical equipment products list (the food drug safety machinery [2011] no. 462) directory of medical equipment management enterprise should deal with the record.

It is hereby notified the above