CAMDI Cooperates with Beijing Municipal Medical Products Administration in a Comprehensive Publicizing and Implementation Training on the Regulations for the Supervision and Administration of Medical Devices
The First Branch of Beijing Municipal Medical Products Administration took the lead to organize and carry out a publicizing and implementation training meeting on the new Regulations for the Supervision and Administration of Medical Devices (hereinafter referred to as “the Regulations”) on May 31, 2021. A member of the propaganda group of the Regulations of the National Medical Products Administration was invited to give special counseling on the new Regulations. More than 120 enterprises and nearly 200 persons from China Association for Medical Devices Industry (CAMDI) and Beijing Medical Device Chamber of Commerce attended the meeting. Wang Fuyi, Deputy Director of Beijing Municipal Medical Products Administration was present at the meeting and gave important instructions.
The new Regulations were approved at the 119th executive meeting of the State Council on December 21, 2020 and become effective from June 1, 2021. The promulgation and implementation of the Regulations are important measures to implement General Secretary Xi Jinping’s people-centered philosophy of development, and reform and improve the regulatory system and mechanism for medical devices, and will help consolidate the achievements of reform, promote innovations in medical devices, promote high-quality industrial development, stimulate market vitality, and meet the people’s demand for high-quality medical devices. The highlights of the new Regulations are the inclusion of registrant system into the supervision system and the use of the concepts of “registrant and filing applicant” corresponding to the concept of “marketing authorization holder (MAH)”. The Regulations specify that the registrant and filing applicant shall establish and effectively operate a quality management system (QMS), strengthen the post-marketing management of products, establish and implement product traceability and recall systems, and assume legal liabilities for the safety and effectiveness of medical devices throughout R&D, production, operation and use.
The newly-revised Regulations for the Supervision and Administration of Medical Devices are characterized with “relaxed market access, strict supervision and severe penalty”. The first is “relaxed market access” that promotes the high-quality development of industry. In terms of specific system measures, the Regulations implement the reform requirements of “streamlining administration, delegating power, strengthening regulation, and improving services”, optimize registration procedures, improve registration efficiency, implement informed filing, scientifically set requirements for clinical evaluation, allow extended clinical trials, encourage medical institutions to carry out clinical trials, strengthen information construction in the supervision and management of medical devices, further optimize the business environment, and release innovation vitality. For instance, informed filing is implemented for low-risk medical devices. The filing is completed simply after the filing applicant submits compliant information, which reduces the burden of filing for enterprises and improves the efficiency. The second is “strict supervision”. Scientific supervision is adopted to promote the modernization of supervision system and supervisory capability. The supervision system for medical devices will be perfected from such aspects as strengthening team construction, innovating supervision means, and promoting collaborative supervision, so as to improve the improve the scientificity, effectiveness and standardization of supervision, and promote the modernization of supervision system and supervisory capability. For another example, the Regulations specify that the unique device identification system should be implemented to provide “electronic ID card" for Medical Devices and strengthen product life-cycle management from source production to clinical use. The third is “severe penalty” aimed at increasing the cost of breaking the law and severely punishing illegal acts. For illegal acts that involve quality safety (QS), the penalty is greatly increased; and the maximum penalty may be 30 times the value of the products in question. The penalties of prohibiting entry into industries and markets are intensified; and the person who breaks the law will be punished by revoking the licenses, prohibiting from engaging in relevant activities for a certain period of time, and refusing to accept relevant license applications, depending on the circumstances of the violation. The “penalties for individuals” are added: The relevant responsible personnel of the serious law-breaking units shall be imposed with confiscation of income, fines, 5 years to lifelong ban from engaging in relevant activities and other penalties.
The legal and normative implementation of production, operation and use activities of medical devices in the future is the only way for enterprises to survive.