Medical appliance sales supervision measures March 1 will come into force | record information system enabled the same day

Pharmaceutical Network February 28 hearing "medical device network sales supervision and management approach" has been promulgated since March 1, 2018. In order to implement the "requirements" of the relevant requirements, CFDA on February 27 issued a circular requiring each After the implementation of the Measures, the food and drug supervision and administration departments at the same level shall step up the supervision and administration of third-party platform providers of online trading services for medical devices and medical devices, and supervise and urge third-party providers of online transaction services for medical devices and equipment. Platform providers effectively fulfill the main responsibility.

The circular pointed out that CFDA has added the functions of medical device network sales and the third-party platform for medical device network transaction services for the record in the 'Medical Device Manufacturing and Business License Record Information System' (hereinafter referred to as 'Information System'), which will be launched on March 1, 2018 The official opening of the day.As for medical device network sales and medical device network transaction service third-party platform for the record, change and other business, the relevant regulatory personnel and business related personnel from the CFDA homepage 'online service' column 'medical device manufacturing and operation License record information system 'Click to enter.

Companies engaged in the sale of medical device network may, through the 'Information System', go through the archival filing with the municipal food and drug administration departments located in the districts where they are located and fill in the medical device network sales information form. The municipal food and drug administration departments in the district shall, To verify, in line with the provisions, it should be within 7 working days to the public record information.

Third-party platform providers for medical device network transaction services can provide provincial-level food through their 'information system' drug Supervision and management department for the record, fill in medical instruments Internet trading services third-party platform for the record and submit the relevant documents, the provincial food and drug administration should be on the spot right enterprise Submitted to the integrity of the material to be checked, in line with the provisions of the record, issued to the medical device network transaction service third-party platform for record vouchers and record within 7 working days after the record to the public relevant record information.