The document clearly indicates that in the future, medical equipment enterprises will be strictly supervised in the big data environment, from research and development, production, circulation, hospital use life cycle for supervision and management!What is the regulatory information platform for medical device manufacturers?
In order to further improve the regulatory mechanism of medical device production, innovate regulatory means and improve regulatory efficiency and level, the State Food and drug administration has established a "regulatory information platform for medical device production enterprises" after one year's construction!
This "medical device manufacturing enterprise supervision information platform" is an intelligent and convenient platform for the whole life cycle of medical devices, relevant data of manufacturing enterprises, strengthening the promotion of flight inspection, special inspection and other actions, as well as strict management of inspectors!
That is to say, this platform not only manages the whole process of IVD enterprise's R & D, production, circulation product hospital use!
In addition, we should promote the convenience of flight inspection, spot check and other actions, and record the products or enterprises with problems in detail! The whole process of inspection should be actively traced!
"Big data" mode highly improves inspection efficiency
First of all, the platform first introduces the requirements of the industry regulations of the catalogue of national key regulatory medical devices and the regulations on the classified and classified supervision and management of medical device manufacturers into the system!
Then the platform will automatically match and form the inspection frequency requirements for relevant enterprises and products, and automatically generate a detailed flow chart containing inspection plan formulation, inspector selection, inspection task release, inspection scheme formulation, etc!
On the other hand, the platform will form an entry type electronic examination form with the complete input system of the national "medical device production quality management specification" and the appendix of aseptic and implantable medical devices, in vitro diagnostic reagents and customized dentures as well as the relevant inspection guidelines!
That is to say, the inspectors in the inspection activities can call relevant laws, regulations and standards for reference in the inspection process at any time!
In addition, in the process of providing inspection automation level, the platform has designed the "double random" function!
In the process of making inspection plan and selecting inspectors, the scope of conditions can be limited or not, so as to realize "double random" of inspection objects and inspectors.
This means that in the pre inspection activities, the inspected enterprises and inspection executors will be randomly selected! This will avoid illegal behaviors such as informing the internal staff in advance, and make the whole inspection process transparent and open!
In addition, the platform also developed a mobile app client, which realized the on-line and off-line operation functions of on-site inspection, so as to meet the requirements of on-site task inspection without network environment!
Follow up the inspection actions of enterprises in the whole process under "big data"The platform integrates the static and dynamic information of manufacturing enterprises, products and inspectors, and enables the query and statistical analysis from multiple dimensions such as by region, by product, by personnel, by inspection defect, and by risk level!
The user-friendly visual interface is formed by charts and other forms, and the static and dynamic data can also be queried in real time. The next step is to further explore and develop the risk early warning function and module of medical devices!That is to say, the platform has imported a complete list of medical equipment enterprises, enterprise products and inspectors. Under the big data mode, the information in these lists has been analyzed and sorted out, and it also provides a hint of which aspect of the enterprise will have risks in the future!
For enterprises, the pressure is not small, because the platform will use big data to record any small mistakes! In the future, the trace of this small mistake is hard to eliminate, and even affect the business activities of the enterprise!
In addition, the platform will integrate the data resources of the whole life cycle of medical devices, from production license, product registration, supervision and inspection, sampling, recall, etc., to realize the dynamic grasp of the static information of IVD manufacturing enterprises (medical device registrants, recorders)!
At the same time, the platform has also built a management sub platform for medical device inspectors, summarizing the basic information, assessment and evaluation, continuing education and inspection information of national and provincial inspectors, so as to realize the management of inspectors!
**After that, in terms of system integration, data connection with the drug regulatory sharing platform of the State Administration will be realized. After the government affairs service platform of the State Administration is completed, it can be connected with the platform and incorporated into the unified identity authentication system of the State Administration!
IVD enterprise supervision * * strict era has come!
it happens that there is a similar case! Earlier, the State Administration of marketing issued the rules for medical devices * * identification system (Draft for comments), which made it clear that the State Drug Administration is responsible for establishing the medical devices * * identification system, formulating and Issuing the implementation plan for the medical devices * * identification system, promoting all parties to actively apply the medical devices * * identification for management, and realizing data connectivity!
It means that all medical device enterprises in the whole country should implement it. In addition, the State Food and drug administration has formulated relevant standards and specifications for the * * identification data of medical devices, organized the establishment of the * * identification database of medical devices for public inquiry.
It means that the medical device * * identification database is to be publicized to the whole country, and all links and information can be followed and checked. **The national implementation conditions of device identification are mature and will be in line with international standards
In February 2017, the notice on the 13th five year national food * * plan and 13th five year national drug * * plan issued by the State Council clearly proposed that medical device coding rules be formulated and medical device coding system be established.
Break the situation of information blocking and self dealing in all aspects of production, operation, use and supervision.