The Party Central Committee and the State Council attach great importance to the quality and safety of medical devices, and pay close attention to the safety and effectiveness of the people's use of machinery. The newly revised "regulations on supervision and administration of medical devices" (hereinafter referred to as the new "regulations") fully implements the "Four most strict" requirements on drug safety, and further clarifies the registrant of medical devices, while the responsibility of the ICP filing person, the production and operation enterprise and the user unit has refined the illegal situation, plus-sized the punishment for illegal acts, and implemented the punishment to the responsible person.
Implement punishment to people and strengthen the legal awareness of responsible personnel:
Implementing the regulation of "punishing people" for illegal acts of medical devices is an important measure to fully implement the "Four most strict" requirements of the Party central committee on drug safety and plus-sized law enforcement, it is of great significance to control and punish illegal acts of medical devices and strengthen the authority of supervision and law enforcement.
The new "regulations" resolutely implement the "Four most strict" requirements, strictly implement the provisions of "punishment to people", and punish illegal units according to law at the same time, the legal representative of serious illegal units, the main person in charge, the directly responsible person in charge and other responsible personnel shall be punished together. The punishment method includes the confiscation of the income earned from the unit during the occurrence of illegal acts, which can be fined up to three times, and it is forbidden to engage in the production and operation of medical devices for 5 years until life.
Implement the "double penalty system" for enterprises and relevant responsible personnel at the same time to make the legal responsibilities of enterprises and their employees clearer, so as to force the relevant responsible personnel of the enterprise to truly fulfill their legal obligations and enhance the consciousness of subject responsibility and rule of law.
Plus-sized penalties and increase the cost of violation of laws and regulations:
The new "regulations" greatly increased the amount of fines for illegal acts. Such as illegal acts such as the production and operation of unregistered medical devices and unauthorized production and operation of medical devices, the amount of fine increased from 20 times the 10 bixdo of the original the value of goods to 30 times the 15 bixdo; For those who fail to apply for the record according to the regulations and fail to correct within the time limit, the fine amount has been increased from less than 10,000 yuan to 20 times of the value of goods bixdo. For the production, operation and use of medical devices that do not meet the requirements of the standard, the operation and use of medical devices have no qualification documents, for expired, invalid, eliminated medical devices and other illegal acts, the maximum fine amount has increased from the value of goods 10 times to 20 times as much as previously stipulated.
Plus-sized penalties and crack down on illegal acts in all aspects of the development, production, operation and use of medical devices, further improving the slow shock effect on illegal acts, it further improves the supervision efficiency of medical devices, protects the healthy development environment and market order of medical device industry, and effectively guarantees the safety of people's use of machinery.
Severely punish serious illegal acts and form a strong shock and explosion effect:
According to the circumstances of the violation, the new "regulations" comprehensively increase the penalties for industry and market prohibition, and stipulate that the illegal acts are ordered to suspend production and business until the production and business license is revoked, punishment measures such as restricting the application for medical device license and prohibiting relevant activities within a certain period of time have further increased the scope of qualification penalty. For the production and operation of Class II and Class III medical devices that have not obtained the registration certificate of medical devices, engage in the production activities of Class II and Class III medical devices without permission, without permission to engage in the third category of medical device business activities and other illegal acts, from the original provisions of 5 years not accept the relevant responsible person and the enterprise's application for medical device license extended to 10 years, it is forbidden for the relevant responsible personnel to engage in the production and operation of medical devices for life; For those who provide false materials or take other deceptive means to obtain medical device registration certificates, medical device production licenses and other licenses, the application for medical device license submitted by relevant responsible persons and enterprises shall be extended to 10 years within 5 years as originally stipulated, and relevant responsible personnel shall be prohibited from engaging in the production and operation of medical devices for life; the direct responsible personnel who provide false information and have serious circumstances during the filing shall not engage in the production and operation of medical devices for 10 years within 5 years as originally stipulated.
In addition, the new "regulations" add punishment measures to prohibit the import of medical devices within 10 years for overseas medical device registrants and registrants who refuse to perform the administrative punishment decision.
The implementation of industry and market ban measures for enterprises with serious violations is conducive to promoting enterprises to hold the "bottom line" of medical device quality and safety, forming a strong shock to enterprises with serious violations and maintaining a high pressure situation, enterprises that touch the "red line" of laws and regulations cannot gain a foothold and promote the healthy and compliant development of enterprises.
Strengthen collaborative supervision and improve comprehensive law enforcement efficiency:
The supervision and management of the development, production, operation and use of medical devices involves many departments and a wide range, the new "regulations" clarify that the relevant departments of the State Council are responsible for the supervision and management related to medical devices within their respective responsibilities, and stipulate that the competent department of health, the public security department, the market supervision department, the entry-exit inspection and quarantine department shall investigate and deal with violations of the new regulations according to their duties. For example, the competent department of health shall investigate and deal with illegal acts of unauthorized allocation and use of large medical equipment; The public security organ shall investigate and deal with counterfeiting, alteration, sale, lease, the violation of public security management constituted by lending relevant medical device license documents shall be investigated and dealt with; The entry-exit inspection and quarantine agency shall investigate and punish the illegal acts of importing medical devices in violation of relevant laws and administrative regulations on import and export commodity inspection; market Supervision departments investigate and deal with violations of the new "regulations" on the management of medical device advertisements. This provides legal guarantee for forming a good pattern of Department cooperation, joint punishment, joint governance, joint management and joint promotion of high-quality and healthy development of medical device industry.
The new "regulations" fully implement the "Four most strict" requirements, which will certainly play an important role in further standardizing the production and operation order of medical devices in our country and ensuring people's health and life safety.
