NMPA（China） issued the regulation of the basic requirement for the unique identification of medical devices

Recently, TheNational Medical Products Administration of People's Republic of China(abbreviated as NMPA) issued the medical industry standard “Basic Requirementsfor the Unique Identification of Medical Devices”, which will be officiallyimplemented on January 1, 2020.

The uniqueidentification standard of medical devices is the basic regulation ofelectronic management of medical devices. Unifying the identification ofmedical devices from the source is conducive to strengthening the supervisionand management of the development, production, operation and usage of medicaldevices, improving the overall efficiency of medical device supervision, andinnovating the mode of medical device supervision. In 2017, the state councilof People's Republic of China issued the "13th five-year national drugsafety plan", which clearly puts forward to construct the coding system ofmedical devices and formulate the coding rules of medical devices. The NMPAactively implemented the spirit of the document and organized the research andformulation of medical device coding standards.

The uniqueness ofthe identification proposed in the basic requirements for unique identificationof medical devices is a basic principle. For medical devices controlled byserial number production, the uniqueness of the unique identification ofmedical devices should be directed to a single product, which can be achievedby meeting international standards, such as ISO/IEC 15459-4 and ISO/IEC15459-6, or by other appropriate means. This standard takes full account of thedevelopment needs of enterprise globalization and reflects the internationalcompatibility and interoperability of the standard.

Zhongguancun Industry and InformationResearch Institute of Two-dimensional Code Technology (ZIIOT), as a global codeissuing agency, participated in the research and pilot work of the formulationof this standard. The IDcode identification system was self- Researched and developedby ZIIOT, in compliance with ISO/IEC 15459 series international standards, hasbeen widely used in more than 30 countries and regions. It is understood thatall countries in the world attach great importance to the unique identificationof medical devices, Europe, the United States and Japan and other developedcountries and regions actively issue relevant regulations and implement thepromotion. At 2017, the FDA of the United States has implemented unique identificationfor category Ⅲ medical devices. The European Unionhas also issued medical device regulations that explicitly implement therelevant regulatory requirements. Japan, Australia and other countries havealso carried out relevant work. With the release and gradual implementation ofChina's basic requirements for the unique identification of medical devices,IDcode identification system will play a positive role in the standardizationand refined management of China's pharmaceutical industry.