According to the "supervision and management of medical device network sales" (November 2017 State Food and Drug Administration Decree No. 38) Article 4, Article 5 and Article 6, the application for the filing of the third party platform provider of medical device network transaction services, should have the following conditions:
1. The third party platform of medical device network transaction services Provider, refers to the medical device network trading only to provide web space, virtual trading place, trading rules, transaction aggregation, electronic orders and other trading services for trading parties or more parties to carry out trading activities, not directly involved in the sale of medical equipment business. Enterprises engaged in the network sales of medical devices, medical device network trading services third-party platform providers should comply with medical device laws, regulations and norms, establish and improve the management system, according to law and integrity of the business, to ensure the quality and safety of medical devices.
2. Engaged in medical device network sales of enterprises, medical device network trading services third-party platform providers should take technical measures to ensure that the medical device network sales data and information is true, complete and traceable.
3. Enterprises engaged in the online sale of medical devices, medical device network trading services third-party platform providers should actively cooperate with the food and drug supervision and management departments to carry out network monitoring, sampling and testing, on-site inspection and other supervision and management, in accordance with food and drug supervision and management department requirements to store data, provide information query, data extraction and other related support.
4. Medical device network trading services third-party platform providers should obtain the "Internet Drug Information Service Qualification Certificate" in accordance with the law, with its scale of office space and data backup, fault recovery and other technical conditions, set up a specialized medical device network quality and safety management institutions or equipped with medical device quality and safety management personnel.
Application materials
According to the "Supervision and Administration of Medical Device Network Sales" (November 2017 State Food and Drug Administration Decree No. 38),application for filing of the third-party platform provider of medical device network trading services should be submitted to the Shandong Provincial Food and Drug Administration to submit the following materials:
1. Signed and stamped application form Scanned version;
2. Legal representative or person in charge of identification;
3. Medical device quality and safety management personnel identification;
4. Organizational structure and departmental setup description;
5. Office location map, documents proving the property rights of the house;
6. Telecommunications Business License; (not mandatory)
7.
7. Non-operational Internet information services for the record description;
8. Internet drug information service qualification certificate;
9. Medical device network trading service quality management system directory;
10. Web site or network client applications and functional description of the basic information;
11. Other relevant materials. (Non-mandatory items)
Processing Flow
(a) Application
1. Network submission: the applicant must be through the provincial bureau of enterprise administrative licensing services flat license declaration.
2. Paper submission
To be filed online matters after the end of the record, the enterprise in the receipt of the record voucher, must be submitted with the approval of the information system electronic version of the declaration of materials identical to the paper material, and stamped with the official seal of the enterprise, for archiving purposes.
(B) Acceptance
1. Material correction
The acceptance of the application materials found to be incomplete or do not meet the statutory form, to make corrective material notice, the applicant logged on to the administrative licensing filing matters service platform system to query and print the notice of correction.