Unified medical device identification from the source

Pharmaceutical Network March 6 hearing 'unique identification of medical devices is the medical device regulatory and industrial development is essential to basic work is to product life cycle management, industrial resources allocation and globalization of the global market to provide identification and traceability Technical means. "Recently, Xu Yimin, senior vice president of registration and clinical practice at Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd., said.

'Building a UDI system is conducive to product life cycle management, internationalization of medical device products and promotion of global standardization management,' said Zhang Chuan, vice president of BioOne Group Co., Ltd., in an interview.

In recent years, the field of medical devices at home and abroad UDI work on the subject of high concern .And on February 27, the State Food and Drug Administration on the "medical device unique identification system rules (draft)" (hereinafter referred to as " Draft for Soliciting Opinions') to solicit opinions from the public and release relevant policy signals, arousing the concern of the medical device regulatory field and the industry.

This reporter has learned that in recent years, UDI work in Europe, the United States and Japan and other developed countries and regions have been promoted.

In 2013, the International Medical Device Regulatory Agency Forum (IMDRF) and the United States Food and Drug Administration (FDA) released the relevant UDI system guidelines and Regulations In 2014, the U. S. FDA took the lead in implementing UDI for the third type of medical device.In May 2017, the EU released medical device regulations to explicitly implement the UDI regulatory requirements, and some countries such as Japan and Australia also started to carry out related work one after another.

What is the significance of UDI for the management of medical devices? It is understood that UDI is the 'electronic identity card' for medical device products, and the unique identification data carrier is the medium for storing or transmitting the 'electronic identification card'. The unique identification database is for storing UDI and related Database of information - these three together form a UDI system.

Through the establishment of an UDI system, it is conducive to the use of information technology to achieve rapid and accurate identification of medical devices in the development, production, operation and use of all aspects, which is conducive to the realization of the sharing and integration of product regulatory data, which is conducive to innovative regulatory models and enhances regulatory effectiveness. , To strengthen the life cycle management of medical devices.

It is noteworthy that Shanghai Municipality carried out some pilot retrospective testing of implantable medical device codes in 2006. In 2012, the State Drug Protection Plan for the Twelfth Five-Year Plan for National Drug Safety called for the launching of the national uniform code for high-risk medical devices Work. "Article 32 of the newly revised" Regulation on the Supervision and Administration of Medical Devices "promulgated in 2014 requires that the state encourages the use of advanced technology to record the sales and use of medical devices. In 2017, the" 13th Five-Year Plan "issued by the State Council Drug safety planning requirements, 'build a medical device coding system, develop medical device coding rules'.

SFDA attaches great importance to UDI work.Reporter learned that in 2013, the State Food and Drug Administration in the development of medical equipment coding research, based on product features and our industry and regulation based on the international development trend, learn from the developed countries and Regional practical experience, put forward to the government norms guide, the implementation of the main business model of the establishment of medical equipment code; 2014, give full consideration to China's regulatory and industrial development practice, drafted the "medical device unique identification system rules (draft)"; 2015, close Tracking the international progress, combining with the latest technology research results, further modifying and perfecting the "Rules for the System of Unique Identification of Medical Devices (Draft)" for the scope of application, coding requirements and database construction, etc. In 2017, the study determined the general idea of ​​coding system construction, The "medical equipment coding system construction work program" and gradually promote the implementation of coding work.

In October 2017, the Office of the Central Government and the State Council issued the Opinions on Deepening the Innovation of Examination, Approval and Approval System to Encourage the Innovation of Medical Devices for Medical Devices, which released a huge policy dividend for the innovation of medical devices. As a result, the reform of medical device examination and approval system accelerated In accordance with the overall deployment of medical equipment coding work, the State Food and Drug Administration repeated research and feasibility studies, formed a draft.

The draft of the Opinions indicates the composition of the UDI system and the definition and related requirements of each component of the UDI system and is the legal basis for the construction of the UDI system.Reclaration Draft According to the revised "Regulations on the Supervision and Administration of Medical Devices" and the combination of "13th Five-Year Plan" country drug Security Plan ", clearly UDI system to establish the purpose of unity from the source medical instruments Identification is conducive to strengthening the supervision and management of medical devices in all aspects of research, production, operation and use so as to enhance the overall effectiveness of medical device regulation and innovate the regulatory model of medical devices.

UDI is a series of alphanumeric codes that are presented on the product or package. It is the unique identifier of the medical device. The UDI is composed of the product identifier and the production identifier. The unique identifier and the basic characteristics of the product Related, should be consistent with the principle of uniqueness, stability and scalability; Uniqueness is the first principle is to ensure that the product is based on accurate identification is the only core function to identify the principle, and because of the complexity of medical devices, UDI's only Sexuality is consistent with product identification requirements. Uniqueness of a unique identifier for a medical device of the same characteristics shall refer to a single specification product; for a medical device that uses serial number production control, the uniqueness of the unique identifier shall point to a single product; and For products under batch production control, uniqueness of the unique identifier points to the same batch of product.

The draft for solicitation also made it clear that the main body of the UDI is the registered holder or the record holder of the medical device, and the user can not create a unique identifier and enforce the source code. standard It is the relevant standard formulated by the SFDA-approved code issuing agency and the relevant standards formulated by the State Food and Drug Administration, which reflects the compatibility of the rules. It not only accepts UDI adopting internationally accepted standards but also is willing to adopt our own Make a standard enterprise Reserved space.

In addition, the draft solicitation also made clear the definition of UDI data carrier, the requirements; UDI database content and requirements, data upload, maintenance requirements; UDI application requirements of all parties, the definition of related terms and implementation date.