关键词: font-size:medium, ">UDI；小微企业；整合资源；赋码制度

Abstract: The new version of the Provisions for Supervision and Administration of Medical Device Manufacturing issued by the State Administration for Market Regulation on March 10， 2022 has taken effect starting from May 1， 2022， which specified the requirements for the implementation of unique device identifier (UDI) and the legal liabilities for non-implementation， and specified the overall requirements for implementing UDI in medical device manufacturers. At present， 80% of the manufacturers of the second and third class medical devices in China are small and micro enterprises with less than 100 employees. This study analyzed the current situation of small and micro enterprises in China to find out the difficulties in implementing UDI for small and micro enterprises.Combining the relevant regulations and requirements for UDI implementation and the advanced means of UDI implementation in EU， the United States and other countries and regions， it is proposed to use the strength of the medical device industry to strengthen the demonstration and leading role of UDI and integrate resources to help small and micro enterprises of medical devices to implement UDI quickly in accordance with the law and at low cost， and explore the self-improvement of UDI coding system， so as to provide experience and ideas for the implementation of UDI in domestic small and micro enterprises.

Key words: font-size:medium, ">UDI； Small and micro enterprises； Resource integration； coding system