Administration of the implementation of "Medical Device Network Sales Supervision and Management Measures" matters
Medical Network February 28 hearing
Provinces, autonomous regions and municipalities Food and Drug Administration, Xinjiang Production and Construction Corps Food and Drug Administration:
The Measures for the Administration of the Sales of Medical Device Networks (No. 38 of the State Food and Drug Administration) (hereafter referred to as the Measures) have been promulgated and will come into force on March 1, 2018. In order to implement the relevant requirements of the Measures , The relevant matters are hereby notified as follows:
First, vigorously do a good job of "measures" propaganda and implementation and training
The food and drug supervision and administration departments at all levels should attach great importance to serious publicity to implement the "Measures", specifically to develop publicity and implementation of training programs, and effectively promote publicity and implementation of training .In January 2018 the State Administration of food and drug administration and other departments The training has been carried out. The provincial food and drug supervision and administration department should strengthen its guidance on the training and related work of the municipal and county food and drug supervision and management departments and enterprises.
Second, conscientiously do a good job medical device network sales supervision and management
(1) Food and drug administrations at all levels shall conscientiously supervise and administer the sales of network equipment for medical devices. After the implementation of the Measures, the third party platform for enterprises and medical device network trading services in the administrative area that are engaged in the sales of medical device networks shall be strengthened Providers supervision and management, urge enterprises and medical equipment online trading services third-party platform providers to effectively fulfill the main responsibility.
(2) Provincial-level food and drug administrations shall, in accordance with the "Measures" and other requirements, effectively handle the disposal of medical device network sales and transaction monitoring information, designate special persons to take charge of receiving information from the national medical device network transaction monitoring platform and investigate and process the results Upload and other related work, and in February 28, 2018 will be medical device network transaction monitoring platform registration application form (Annex 1) submitted to the General Administration of Device Supervision.
Third, on the medical device network sales and medical device network transaction services third-party platform for the record
(A) The Administration has added the functions of network sales of medical equipment and registration of the third-party platform for medical device network transaction services in the Record Information System for the License for the Production and Operation License of Medical Device (hereinafter referred to as the "Information System"), which will be released on March 1, 2018 The formal opening of the day.For the medical device network sales and medical equipment online trading services third-party platform for the record, change and other business, the relevant regulatory staff and business related personnel from the State Food and Drug Administration Web site 'home affairs' column 'Medical equipment manufacturing license information system' Click to enter.
(II) Enterprises engaging in the sales of medical device network may, through the 'Information System', go through the archival filing with the municipal-level food and drug supervision and administration department of the district where the medical device is located and fill in the medical device network sales information form (Appendix 2) and the municipal-level food and drug The supervisory and administrative department verifies the information reported and, if it meets the stipulations, shall open the record-keeping information to the public within 7 working days.
(C) medical device network transaction services Third-party platform providers through the 'information system' to the provincial food drug Supervision and management department for the record, fill in medical instruments Online trading service third-party platform for the record (Annex 3) and submit the relevant materials (Annex 4), the provincial food and drug administration should be on the spot right enterprise Submit the completeness of the materials to check, meet the requirements for the record, medical equipment online trading services issued to the third-party platform record voucher (Annex 5) and within 7 working days after filing to the public relevant record information.
System Advisory E-mail: cfda_qa@163.com
Annex: 1. Medical Device Network Transaction Monitoring Platform registration application form
2. Medical Device Network Sales Information Form
3. Medical equipment online trading services third-party platform for the record
4. Medical device network transaction services third-party platform for the record of the required materials
5. medical equipment online trading services third-party platform record voucher
