Food and Drug Administration in each province, autonomous region and municipality and Food and Drug Administration of Xinjiang Production and Construction Corps:
Measures for the Supervision and Administration of Online Sale of Medical Devices (The Order No.38 of State Food and Drug Administration) (hereinafter referred to as the Measures) has been released and will be implemented on March 1, 2018. To put into practice the relevant requirements in the Measures, the relevant matters are hereby notified as follows:
1. Work for promotion, implementation and training of the Measures
2. Work for supervision and administration of online sale of medical devices
(1) Food and drug administrations at each level shall work hard for the supervision and administration of online sale of medical devices. After the implementation of the Measures, they shall strengthen the supervision and administration of the enterprises engaged in online sale of medical devices and the third-party platform providers involved in online trade of medical devices within the administrative region and urge those enterprises and third-party platform providers to fulfill their entity responsibilities.
(2) Food and drug administrations in each province shall, based on the requirements in the Measures, well deal with the online sale and trade monitoring information of medical devices, designate people to receive information and upload survey results to the National Monitoring Platform for Online Trade of Medical Devices, and submit the Application Form for Registration on Monitoring Platform for Online Trade of Medical Devices (Attachment 1) to CFDA Medical Device Supervision Department before February 28, 2018.
(3) About records of third-party platforms for online sale and trade services of medical devices.
Attachment:
1. Application Form for Registration on Monitoring Platform for Online Trade of Medical Devices
2. Form for Online Sale Information of Medical Devices
3. Record Form for Third-party Platforms for Online Trade Services of Medical Devices
4. Required Recordation Materials for Third-party Platforms for Online Trade Services of Medical Devices
5. Recordation Certificate for Third-party Platforms for Online Trade Services of Medical Devices
Measures for the Supervision and Administration of Online Sale of Medical Devices (The Order No.38 of State Food and Drug Administration) (hereinafter referred to as the Measures) has been released and will be implemented on March 1, 2018. To put into practice the relevant requirements in the Measures, the relevant matters are hereby notified as follows:
1. Work for promotion, implementation and training of the Measures
2. Work for supervision and administration of online sale of medical devices
(1) Food and drug administrations at each level shall work hard for the supervision and administration of online sale of medical devices. After the implementation of the Measures, they shall strengthen the supervision and administration of the enterprises engaged in online sale of medical devices and the third-party platform providers involved in online trade of medical devices within the administrative region and urge those enterprises and third-party platform providers to fulfill their entity responsibilities.
(2) Food and drug administrations in each province shall, based on the requirements in the Measures, well deal with the online sale and trade monitoring information of medical devices, designate people to receive information and upload survey results to the National Monitoring Platform for Online Trade of Medical Devices, and submit the Application Form for Registration on Monitoring Platform for Online Trade of Medical Devices (Attachment 1) to CFDA Medical Device Supervision Department before February 28, 2018.
(3) About records of third-party platforms for online sale and trade services of medical devices.
Attachment:
1. Application Form for Registration on Monitoring Platform for Online Trade of Medical Devices
2. Form for Online Sale Information of Medical Devices
3. Record Form for Third-party Platforms for Online Trade Services of Medical Devices
4. Required Recordation Materials for Third-party Platforms for Online Trade Services of Medical Devices
5. Recordation Certificate for Third-party Platforms for Online Trade Services of Medical Devices
General Office of China Food and Drug Administration
February 24, 2018
February 24, 2018