On August 27, 2019, the Chinese regulatory Authority (NMPA) promulgated the Regulations for the Supervision and Management of Medical Devices, i.e. the Rules of the Medical Device Unique Identification System. The final rules will come into effect on October 1, 2019
Taking a similar approach to that of the U.S. FDA for its UDI database, the general idea was to build a system that could fully identify a medical device throughout its whole lifecycle. The devices marketed in China shall be assigned a Unique Device Identifier (UDI) and the UDI shall comply with the rules formulated by NMPA. All the stakeholders in the UDI supply chain have a part to play in the creation and implementation of such system.
The first stage consisted in establishing an UDI Regulation; rules were developed as a guidance for the UDI implementation and lay out the framework and the responsibilities of the medical device registrant/applicant and manufacturer as well as those of the UDI issuing agencies.
The next stages in the implementation of the UDI system in China are as follows:
- the development of supporting Standards and guidelines on unique identifier, data carrier and database, and carry out the coding standardization;
- create an information system: gradually building an UDI database based on application demands
- Launching an UDI Pilot program that will initially target high-risk devices.