China News Service, December 22. According to the website of the China Food and Drug Administration, recently, the State Food and Drug Administration has formulated and promulgated the “Measures for the Supervision and Administration of Online Sales of Medical Devices” (hereinafter referred to as the “Measures”). The “Measures” stipulate that enterprises engaged in online sales of medical devices and third-party platforms for online transaction services of medical devices must fulfill six obligations including filing obligations.

The “Measures” clarify the principle of “consistency between online and offline”. For enterprises engaged in the online sales of medical devices, the applicant should be the entity medical device production and operation enterprises that have obtained medical device production licenses, business licenses or filed records in accordance with the law, and meet the sales conditions.

The medical device marketing license holder (ie the medical device registrant or filer) required by the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures” operates through a self-built website (including network client applications) or medical device network. Transaction Services Third-party platforms sell medical devices.

In addition, the “Measures” also clearly stipulates that medical device network information services shall be implemented in accordance with the “Administrative Measures for Internet Drug Information Services”. Therefore, enterprises engaged in online sales of medical devices through self-built websites and third-party platform providers of medical device online transaction services shall obtain Internet drug information service qualification certificates in accordance with the “Administrative Measures for Internet Drug Information Services”.

The “Measures” stipulate that enterprises engaged in online sales of medical devices and third-party platform providers of medical device online transaction services shall perform the following obligations:

The first is to fulfill the filing obligation. Enterprises engaged in online sales of medical devices shall file with the food and drug administration at the districted city level where they are located. If the relevant information changes, the filing information shall be changed in a timely manner. Providers of third-party platforms for medical device online transaction services shall file with the local provincial food and drug administration. If the relevant record-filing information changes, the record-filing shall be changed in a timely manner.

The second is to establish relevant systems for medical device quality management. Providers of third-party platforms for online medical device transactions shall establish and implement verification and registration, quality and safety monitoring, transaction security guarantees, online sales of illegal acts, suspension of platform services, and safety complaints and reports for the medical device manufacturers and distributors that have entered the platform. Management systems for handling, consumer rights protection, and quality and safety information announcements.

The third is the obligation to review and register. Providers of third-party platforms for online medical device transactions shall verify and register the medical device production and operation licenses or record-filing certificates, medical device registration certificates or record-filing certificates, and enterprise business licenses provided by the medical device production and operation enterprises that apply for entry into the platform, and establish The files are updated in a timely manner, and a settlement agreement is signed with the medical device production and operation enterprises that have entered the platform to clarify the obligations of both parties and the measures to deal with breach of contract.

Fourth, the relevant requirements for qualifications, sites, technical conditions and management personnel. Enterprises engaged in online sales of medical devices and third-party platform providers for online transactions of medical devices shall obtain the “Internet Drug Information Service Qualification Certificate” in accordance with the law, have office space commensurate with their scale, and technical conditions such as data backup and failure recovery, and set up special Medical device network quality and safety management institutions or medical device quality and safety management personnel.

Fifth, platform management obligations. The provider of the third-party platform for online trading of medical devices shall monitor the sales behavior and information of medical devices on the platform, and find that the medical device production and operation enterprises that have entered the third-party platform for online trading services have violated the law, and shall immediately stop the online trading services. And keep relevant records and report to the local provincial food and drug supervision and administration department. If it is found that a medical device production and operation enterprise that has entered a third-party platform for online transaction services has been ordered by the food and drug administration to suspend production, suspend business, or have its license revoked, it shall immediately stop providing online transaction services to it.

The sixth is the obligation to record. Enterprises engaged in online sales of medical devices and third-party platform providers for online transactions of medical devices shall record medical device transaction information, and the records shall be kept for 2 years after the validity period of the medical device; if there is no validity period, the retention time shall not be less than 5 years; The medical device transaction information shall be kept permanently. Technical measures should be taken to ensure the authenticity, integrity, safety and traceability of online sales data and materials of medical devices.

The “Measures” point out that the network business scope of medical devices shall not exceed the scope of its production and business license or filing. Medical device wholesale enterprises engaged in online sales of medical devices shall sell to qualified medical device operating enterprises or user units. Medical device retail enterprises engaged in online sales of medical devices shall sell to consumers. Medical devices sold to individual consumers should be self-useable by consumers, and their instructions should comply with the relevant regulations on medical device instructions and label management, with special instructions for safe use. It should be that medical devices used by medical institutions cannot be sold to individuals.