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Original title: New medical device regulations to be implemented on June 1, registrant system releases dividends and implements liability
The medical device industry has always had the problem of “scattered small-scale industries and mixed industries”. Repeated and fierce competition has become the norm. The new device registration system is expected to fundamentally change this chronic disease.
On December 21 of last year, the executive meeting of the State Council reviewed and approved the revised draft of the “Regulation on the supervision and administration of medical devices” (hereinafter, the “Regulation”). The “Regulation” was officially announced to the public and will be formally implemented on June 1 this year.
“The most important feature of the new ‘Regulation’ can be summed up in four words: one is ‘new’, which adds many new systems, new mechanisms and new methods to improve governance; the other is ‘excellent’, which simplifies and optimizes the review The approval process is focused on improving the effectiveness of supervision; the third is “comprehensive”, which refines and improves the responsibilities of the entire life cycle of the quality and safety of medical devices; the fourth is “strict “to further increase the punishment for violations of laws and regulations.” March 26, Xu Jinghe, deputy director of the State Drug Administration, said at the State Council policy briefing held by the State Council Information Office.
Implement primary responsibility and release dividends from the system.
Xu Jinghe said that the medical device registration system is a modern medical device management system commonly adopted by the international community, and it is also one of the core systems for the revision of the Regulation on the supervision and management of medical devices. The core of the system is that the medical device registrant is the “producer” of the medical device product and is responsible for the safety and effectiveness of the medical device throughout the development, production, operation and use process.
“The registration system is not only about setting aside the production-to-order concept and setting up factories in different locations, but more importantly, the essence of the registrant is that the registrant must also assume the Relevant responsibilities for medical device research and development, such as problems in clinical trials, manufacturing and sales. The registrant should also be held accountable, “said a person in charge of a medical device manufacturer.
In fact, to implement the “Opinions on the deepening of the review and approval system reform and the promotion of innovation in drugs and medical devices” of the Office of the State Council of the People’s Republic of China, the State Administration of Food and Drug Administration has launched a pilot program for the medical device registration system, and the scope of the trial has reached 22 states / provinces / states. It focuses on “whether scientific research institutions can become registrants of medical devices”, “how to divide the rights and obligations between the registrant and the trustee when the registrant entrusts the production”, “how to assign the powers and responsibilities of the department of oversight when commissioning production to a different location “and” How to effectively implement registrant lifecycle responsibilities “and other pilot projects.
“Practice has shown that the registrant system favors R&D innovation, optimizes the allocation of resources, favors the implementation of key responsibilities and favors the promotion of innovation in management,” said Xu Jinghe.
The industry also expects the medical device registration system to pay dividends, furthering industry concentration and competitiveness.
Industry believes that the design of this system can prevent researchers from having to “sell young crops” due to lack of experience in transforming results and further stimulate enthusiasm for scientific research and innovation. The implementation of the medical device registration system allows scientific research and innovative enterprises do not need to invest a lot of financial resources to build factories, do not invest too much management energy, but rather focus on R&D and improvement, form professional teams and use existing ones. production resources to organize production and manufacturing Further shorten the product listing cycle and reduce the cost of product listing.
The new regulations further clarify the core content of the medical device registration system. The “Regulations” clearly stipulate that medical device registrars and registrars will strengthen the quality management of the entire life cycle of medical devices and will be responsible for the safety and efficacy of medical devices throughout the development, production process. , operation and use. .
In terms of production, the “Regulation” stipulates that registrars and registrars of medical devices can produce them on their own or entrust companies with the corresponding conditions to produce them. In the case of commissioned production, the registrant and the person in charge of filing will be responsible for the quality of the commissioned production of medical devices, strengthen the management of commissioned production activities and ensure that they are produced in accordance with the legal requirements. Importantly, high risk implantable medical devices should not be put into operation for production.
In terms of business operations, medical device registrars and registrars should supervise operating companies to establish and improve a quality management system that is compatible with the medical devices they operate, and ensure their effective operation; those who sell online must comply with the relevant regulations. online sales provisions.
With respect to adverse event monitoring, the “Regulations” stipulate that medical device registrars and record holders must establish a medical device adverse event monitoring system and conduct investigations and management of adverse events in a timely manner. The new “Regulations” stipulate that medical device registrars and registrars must take the initiative to carry out a re-evaluation of medical devices already on the market and take the corresponding risk control measures based on the results of the re-evaluation. .
Increase in illegal costs
The new regulation fully implements the “four stricter requirements” on drug safety. While it further clarifies the responsibilities of medical device registrants, registry holders, manufacturing and operating companies and users, it also refines the circumstances of violations and increases the level of protection against violations of laws and regulations. The sanctions will be applied to those responsible.
The new “Regulation” stipulates that the “four stricter requirements” must be applied resolutely and the requirement to “punish the person” must be strictly applied. Although the units that violate the law are penalized in accordance with the law, they must be directly responsible for the legal representatives, main responsible parties and direct responsibility of the units that violate the Law. The competent personnel and the rest of the responsible personnel will be sanctioned jointly. The sanctions include the confiscation of the income received from the unit during the period of the illegal act and a maximum fine of 3 times, prohibiting them from participating in activities of production and operation of medical devices from 5 years to life imprisonment.
“Increase penalties for infractions involving quality and safety, and fines up to 30 times the value of the merchandise. At the same time, increase the penalties for prohibition of entry to the industry and the market. Depending on the circumstances of the violation, violators will be subject to revocation of their licenses and will be prohibited from participating for a specified period. Penalties for related activities and non-acceptance of related permit applications. Increase the measure of ‘sanction to the person’ and impose sanctions such as confiscation of income, fines, and the prohibition of five years to life of related activities in the relevant responsible personnel of the units that seriously violate the law, “said the director of the Third Legislation of the Ministry of Justice, Wang Zhenjiang.
In fact, severe penalties are not just that. The new regulations also implement a “double penalty system” for companies and their responsible personnel, which clarifies the legal responsibilities of companies and their employees, forcing the responsible personnel of companies to actually comply with their own legal obligations and increase awareness of the responsibility of the subject and the rule of law.
For those who provide false information or use other misleading methods to obtain medical device registration certificates, medical device production licenses and other licenses, the 5-year stipulated original will not accept medical device license applications submitted by individuals and responsible companies to 10 years, and the service life will be extended to 10 years. Relevant responsible personnel are prohibited from participating in the production and operation of medical devices; For those directly responsible for providing false information during filing and the circumstances are serious, they will not be allowed to participate in the production and operation of medical devices for 10 years from the originally stipulated 5 years. For overseas medical device registrars and registrars who refuse to implement the administrative penalty decision, the new “Regulation” added penalties that prohibit the importation of medical devices within 10 years.
The implementation of industry and market prohibition measures for companies that seriously violate the law leads to urge companies to maintain the “bottom line” of quality and safety of medical devices, which constitutes a strong element of deterrence and maintains a high pressure situation for companies that seriously violate the law, so that companies that touch the “red line” of regulations cannot take hold. Promote the healthy and compliant development of companies.
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