Basic Information on the Document
The Measures for the Supervision and Administration of Online Sales of Medical Devices were reviewed and adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017, promulgated by Order No. 38 on December 20, 2017, and took effect on March 1, 2018. Comprising six chapters and fifty articles, they are the first departmental rule in China dedicated to regulating the online sales of medical devices.
Applicable Parties
The Measures apply to two categories of parties: first, enterprises that sell medical devices online (which must hold the corresponding distribution license or filing certificate); and second, third-party platform providers that provide online transaction services for the online sales of medical devices.
Main Provisions
Online sales enterprises must truthfully display information such as the product registration certificate and the distribution license or filing certificate; they must establish a quality management system and retain sales records and delivery records. Third-party platforms must file with the provincial drug regulatory department and obtain a filing certificate, review the qualifications of the enterprises operating on the platform, and bear management responsibilities.
Prohibitive Provisions
The Measures expressly prohibit the online sale of preparations dispensed by medical institutions and other medical devices that may not be sold online (the specific catalogue is to be formulated separately by the National Medical Products Administration). Drug regulatory departments may take measures such as ordering cessation, warnings, and fines in accordance with the law.
Source: China Food and Drug Administration, Measures for the Supervision and Administration of Online Sales of Medical Devices (CFDA Order No. 38), Gazette of the State Council on the Chinese Government Website, https://www.gov.cn/gongbao/content/2018/content_5277700.htm