State Drug Administration: Medical identity card landing, enterprise inspection began.

Pharmaceutical Network July 31st, supervision of production, circulation, use of all links 1, unique marking system framework has been completed 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 deployment.
the State Drug Administration pointed out that the only identification of medical devices is the "identity card" of medical devices, is the only, accurate identification of medical devices, throughthe production, circulation, use of all links, conducive to the entire life cycle management of medical devices.
previously, the State Drug Administration and the National Health and Health Administration have jointly carried out a unique marking system pilot work.
on the ground in the provinces, the introduction of medical device unique identification system rules, issued the relevant standards, built a unique identification database, medical device enterprises actively participate in the pilot, medical institutions began to unique identification application.
at present, the domestic has basically built a unique identity system framework, to achieve unique identity creation, coding, data upload download and sharing.
unique identification in the production, circulation, use of the whole chain of all links began to demonstrate the application, so that medical devices from the source of production to the final clinical use of the chain linkage, the implementation of the whole process of supervision.
2, medical device coding linked to the Medical Insurance National Drug Administration pointed out that the construction of the unique marking system is a foundation for long-term work.
the successful pilot of unique identification system, vertically verified the possibility of implementing unique identification in all links of the whole chain of medical devices, and horizontally verified the convenience of the unique identification in the "three medical linkage" to promote the precise management of medical devices.
three medical linkage is the health insurance system reform, health system reform and drug circulation system reform linkage, popularly speaking: medical care, medical insurance, medical reform linkage, that is, "three medical linkage."
According to Xinhua News, in the three medical linkage, medical insurance on medical, medical resources rational 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 only identification in the medical, medical insurance work application, under this influence, the future health insurance and coding collaboration, regardless of payment, settlement, repayment and other aspects will be fully implemented.
the end of June, Taiyuan City, Shanxi Province, the Medical Insurance Bureau issued "on the volume of procurement of selected varieties of precision infusions to implement the health insurance payment management notice", the content simply pointed out that from July 1, no new medical insurance code related supplies, medical insurance funds will not be paid.
at the same time, the relevant medical insurance departments should, in accordance with the national medical insurance coding rules, timely docking with the provincial medical insurance management departments, the use of new unified medical insurance code for precision infusions, distinguish between different functional types and production enterprises.
fixed-point medical institutions must be based on the type of related supplies, production enterprises, etc., corresponding to the unified code upload fee information, as the basis for the settlement and payment of the medical insurance fund.
3. In-depth enterprise inspection implementation at this meeting, the State Drug Administration pointed out that the medical device will be inspected for the implementation of the unique identification of medical devices.
(Picture Source: State Drug Administration) The State will continue to promote the follow-up work in the construction of a unique marking system, establish a unique marking demonstration communication mechanism, and establish a unique marking demonstration point in all aspects of medical device production, operation, use and supervision.
do a good job of the supervision and inspection of the only identification pilot enterprises.
at the same time in-depth medical device enterprises, medical institutions and other unique identification of the pilot line, research the pilot situation, do a good job of the pilot summary, for the implementation of unique identification to lay the foundation.
representatives from medical institutions, medical device production and business enterprises reported and exchanged the application of the unique identification in the production, circulation and use of medical devices. On 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 contentofof of the unique identification of medical devices.
it pointed out that the use of pharmaceutical supplies will be strengthened supervision.
gradually establish and improve the drug information traceability mechanism, to achieve vaccines and national organizations to centralize the procurement and use of drugs "one thing, one yard", select some high-value medical supplies and other key varieties of the implementation of unique identification of medical devices.
to build a unified and open national market for centralized drug procurement, unify standards and functional norms, and promote the use of medical insurance drug coding.
gradually unified the national medical insurance high-value medical supplies classification and coding, explore the implementation of high-value medical supplies registration, procurement, use and other aspects of the interface of coding applications.
4, unique identification has entered the implementation stage can be seen, the medical device unique identification system pilot work into the implementation phase.
UDI system, strengthen the source of code, from the source of production to clinical use of the whole chain of medical equipment to understand.
UDI, is usually seen on the drug box on the regulatory traceability code? UDI is an acronym for Unique Device Identification, the only device identity, an identity assigned to a medical device throughout its life cycle, and the only "ID card" in the product supply chain.
simple, UDI coding can be in product manufacturing, warehousing, logistics, hospital supplies management, national adverse event scare supervision, product recall and other product life cycle process to achieve automatic identification, accurate traceability, the entire supply chain it is in.
, the device identification DI belongs to the static information, it is the identification of medical device products in the supply chain, can be used as the "keyword" to enter the database to query the basic information of the product.
and the production of logo PI belongs to dynamic information, it includes the serial number of medical device products, lot number, date of production and expiration date, etc., is the dynamic additional information of medical device products, it is used in conjunction with DI, in order to point to specific medical device products.
medical supplies because of the difficulty of coding has been the medical community concern.
supplies are different from drugs, supplies not only a wide variety of supplies and a wide variety of, the same product in different regions when bidding and procurement of different names, around the various policies on consumables, to supplies tender procurement and payment and other links bring a lot of inconvenience.
based on this, medical supplies coding standards appear.
5, 116 armed enterprises, 108 hospitals first pilot at present, a number of medical deviceenterprises have been testing water.
the State Drug Administration has issued a "Notice on the implementation of a pilot training for a unique marking system for medical devices".
from the list of participating companies can be seen, a total of 116 enterprises, there is no shortage of Medtroni, Stryker and other industry giants.
at the same time, the first batch of 108 medical institutions have been announced.
(Annex 1 is a list of pilot enterprises)