Following the launch of the China’s national UDI system, the Hainan Medical Products Administration (MPA) announced (No.114-2020) the commencement of their pilot plan for the UDI system in Hainan on November 27, 2020.
China’s National UDI System
From January 1, 2021 onwards, all companies with medical devices listed in the first batch are officially required to submit the product identification (DI) in the registration management system for:
- First registrations
- Renewal registrations
- Product change applications
The UDI code must be labelled for products manufactured on or from January 1, 2021 onwards. Watch NMPA’s short introductory video about their online UDI database.
Hainan’s UDI System (Pilot Plan)
In addition to the first batch of medical devices required by China’s national UDI system, Hainan’s UDI system plans to cover 18 types of high-risk class III medical devices (announced in No.9 – 2020 by the China National Health Commission last year on January 14), and 11 specified types of class II and III medical devices (announced in No.114-2020 by the Hainan MPA).
The Hainan MPA addressed the following targets to be achieved:
November – December 2020
- Establish a working group
- Make suggestions and preparation for the layout work of the UDI system
- Organize training and practice
- The Hainan MPA should keep the NMPA updated on the implementation progress of the pilot plan
- Applicants in Hainan whose products are mentioned on the specified list of class III medical devices shall submit the DI by the end of December 2020
April 2021
- Hold an internal meeting to follow up on the implementation progress and review the common issues
December 2021
- Applicants in Hainan whose products are mentioned on the specified list of class II medical devices shall submit the DI by the end of December 2021
- The implementation of the UDI system in Hainan shall be completed by the end of December 2021 for sharing information about the registration approvals, clinical data, medicare settlement, etc. online
The following participants are expected to be involved in the pilot plan:
- The Hainan MPA
- The Hainan National Health Commission (NHC)
- The National Healthcare Security Administration of Hainan
- Hainan class II and III applicants
- Specified business enterprises and public medical institutes above the B grade
- The Pharmaceutical Profession Association
- UDI code agencies
By Jacky Li. Contact Cisema if you would like to learn more.
