The State Administration for Market Regulation publicly Solicits Opinions on the Rules of Unique Device Identification (UDI) System

  • 2018-08-23
On August 22, the State Administration for Market Regulation released a notice on soliciting public opinions on the Rules for the Unique Device Identification System for Medical Devices (Exposure Draft) According to the State Administration for Market Regulation, to strengthen the monitoring and management in the process of the development, production, marketing and use of medical devices, the Rules for the Unique Device Identification System for Medical Devices (Exposure Draft) was drafted for collection of public comments, which ends on September 21, 2018.

As a matter of fact, this is not the first national release of the Rules for the Unique Device Identification System for Medical Devices (Exposure Draft). On February 28 this year, the former China Food and Drug Administration issued the Rules for the Unique Device Identification System for Medical Devices (Exposure Draft) and its preparation instructions. Simultaneously, it submitted WTO/TBT notifications. There are 96 opinions on the clauses of the Rules, which mainly related to the compliance of specific categories of devices, principle for exemption, requirements on the time limit for data uploading, related requirements on the creation of the new unique device identification (UDI) and determination of the identification code issuing organization.

Compared with the previous version, this latest version of the Exposure Draft (Refer to the attachment) is partly modified and updated, detailing “Definition of UDI system” and adding “Principle of Construction” and “Requirements on Identification Code Issuing Organization”.

The creation of UDI system facilitates the fast and accurate identification in the course of production, marketing and use of the medical devices by information-based tools, fosters the sharing and integration of regulatory data, benefits the creation of regulatory model and increase of regulatory effectiveness and helps strengthen the life-cycle management of medical devices and achieve the combination of government regulation and social governance to create a situation of shared governance and to further improve the safety of the public in use of such devices.

UDI is a hot-button issue in the field of global medical device regulation and the direction for innovation of the global medical device regulatory tools and improvement of regulatory effectiveness. In China, the regulatory authority in Shanghai carried out the pilot work for code traceability of partially implantable medical devices in 2006. The State Council issued the Plan for Drug Safety during the Period of the Twelfth Five-Year Plan, clarifying the “start of the national unified coding of high-risk medical devices” in 2012. Article 32 of the revised 2014 Regulations on Supervisory Management of Medical Devices (referred as to the Regulations) states that the state encourages to adopt advanced technologies and measures to make the marketing and usage records of medical devices. The Plan for Drug Safety during the Period of the Thirteenth Five-Year Plan issued by the State Council in 2016 requires “establishment of the medical device code system and development of the medical device code rules”. It is common in the circulation and application of medical devices to encounter the problem of multiple codes for one item which influences the accurate identification of medical devices and information sharing between the related parties. It is urgent for the state to issue relevant laws and regulations to eliminate the information isolated island and ensure the consistency and accuracy of medical device identification. Our country is in urgent need of construction of the UDI system for medical devices.

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