State Drug Administration: Medical ID card landing enterprise inspection began.

July 28, according to the official website of the State Drug Administration, the Bureau recently held a medical device unique identification system pilot work promotion meeting, on the next step to promote the pilot work to deploy.
The State Drug Administration pointed out that the only identification of medical devices is the "ID card" of medical devices, is the only, accurate identification of medical devices, throughout the production, circulation, use of medical devices, help medical devices throughout the life cycle management.
, the State Drug Administration and the National Health And Health Commission have jointly carried out a pilot of the unique marking system.
in the provinces, the introduction of the unique identification system rules for medical devices, the release of relevant standards, built a unique identification database, medical device enterprises actively participate in the pilot, medical institutions began to unique identification applications.
, the domestic has basically built a unique identity system framework, to achieve unique identity creation, assignment, data upload download and sharing.
Unique logo in the production, circulation, use of all links of the whole chain of medical devices began to demonstrate the application, so that medical devices from the source of production to the final clinical use of the whole chain linkage, the implementation of the whole process of supervision.
medical device coding linked to the National Drug Administration pointed out that the construction of the unique marking system is a foundation for long-term work.
the successful pilot of the unique identification system, vertical verification of the medical device chain of all links to implement the possibility of unique identification, horizontal verification of the unique logo in the "three medical linkage" to promote the convenience of medical device precision management.
three medical linkage is the medical insurance system reform, health system reform and drug circulation system reform linkage, popularly said is: medical, medical insurance, medical reform linkage, that is, "three medical linkage."
, according to Xinhua news, the three medical linkage, medical insurance for medical, medical resources reasonable allocation and scientific use of the core leverage.
"Medical reform is to change health insurance", and the coding of the landing and linkage, explore the unique logo in the medical, medical insurance work applications, under this influence, the future health insurance and coding synergy, regardless of payment, settlement, repayment and other aspects will be fully implemented.
in late June, Taiyuan City Health Insurance Bureau of Shanxi Province issued a "Notice on the implementation of medical insurance payment management of precision infusions of selected varieties in the procurement of belt volume", which stated that from July 1, no new medical insurance code related supplies, the medical insurance fund will not pay.
meanwhile, the relevant medical insurance departments should, in accordance with the rules of the national medical insurance code, promptly connect with the provincial health insurance administration departments, adopt a new unified code for precision infusions, distinguish between different types of functions and production enterprises.
designated medical institutions must upload fee information according to the type of related consumables, production enterprises, etc., corresponding to the unified code, as the basis for the settlement and payment of medical insurance funds.
in-depth enterprise inspection of the implementation of this meeting, the State Drug Administration pointed out that medical devices will be checked for the implementation of the unique logo of medical devices.
(Picture Source: State Drug Administration) The State will continue to promote the follow-up work on the construction of a unique marking system, establish a unique marking demonstration exchange mechanism, and establish a unique identification demonstration point in all aspects of medical device production, operation, use and supervision.
to do a good job of the sole identification of the pilot enterprise supervision and inspection work.
also in-depth medical device enterprises, medical institutions and other unique logo pilot line, research the pilot situation, do a good job of pilot summary, for the implementation of the unique logo to lay the foundation.
representatives from medical institutions, medical device production and operation enterprises reported and exchanged information on the application of unique logos in all aspects of the production, circulation and use of medical devices.
July 23, the General Office of the State Council issued the "Key Tasks for Deepening the Reform of the Medical and Health System in the Second Half of 2020", which requires the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, ministries and agencies under the State Council, to organize and implement them in the light of the actual situation, with emphasis on the content of the unique logo of medical devices.
that regulation of the use of pharmaceutical supplies will be strengthened.
gradually establish and improve the drug information traceability mechanism, to achieve vaccines and national organizations to focus on the procurement and use of drugs "one thing, one yard", select some high-value medical supplies and other key varieties to implement the unique identification of medical devices.
to build a unified and open centralized drug procurement market, unified standards and functional norms, and promote the use of medical insurance drug codes.
gradually unify the classification and coding of high-value medical supplies for national medical insurance, and explore the implementation of high-value medical supplies registration, procurement, use and other links to standardize the application of coding.
the unique identification of medical devices has entered the implementation stage can be seen, medical device unique identification system pilot work into the implementation stage.
UDI system, strengthen the source of code, from the source of production to clinical use of full chain medical devices to check the general knowledge.
UDI, is it usually seen on the drug box on the regulatory traceability code? UDI, an acronym for Unique Device Identity, translates directly to be the only device identification, the identity given to a medical device throughout its life cycle, and the only "ID card" in the product supply chain.
simply put, UDI code can be in product manufacturing, warehousing, logistics, hospital supplies management, national adverse event supervision, product recall and other product life cycle process to achieve automatic identification, accurate traceability, the entire supply chain it is in.
, device identification DI is static information, it is the identity of medical device products in the supply chain, can be used as a database to query the product traceability of basic information "keywords."
And the production logo PI is dynamic information, it includes the serial number of medical device products, batch number, production date and expiration date, etc. , is the dynamic additional information of medical device products, it is used in cooperation with DI, in order to point to a specific medical device products.
medical supplies have been the focus of medical attention because of the difficulty of coding.
Supplies are different from medicines, supplies are not only a large number and a wide variety of supplies, the same product in different regions when bidding and procurement of different names, all over the policy provisions on supplies are diverse, to the supplies tender procurement and payment and other links bring a lot of inconvenience.
, medical supplies coding standards appear.
116 equipment enterprises, 108 hospitals pilot at present, a number of medical equipment enterprises have been testing water.
The State Drug Administration has issued a "Notice on the implementation of medical device unique marking system pilot training."
from the list of companies participating in the training, there are 116 enterprises, including Medtron, Stryker and other industry giants.
the same time, the first batch of 108 medical institutions piloted has also been published.
(Annex 1 for the list of pilot enterprises, Annex 2 for the list of pilot hospitals)