Tang Minhao, chief researcher of the Shanghai Food and Drug Safety Research Association, introduced that in order to ensure the safety and effectiveness of medical apparatus, protect human health and life safety, and promote the development of the medical apparatus industry, in December 2020, the 119th executive meeting of the State Council revised and passed the "Regulations on the Supervision and Administration of Medical Apparatus".
"Although the regulations provide a solid foundation for the rule of law construction of medical apparatus in our country, in response to the increasingly complex industrial situation and global governance trends, the development of our country's medical apparatus industry urgently needs a more systematic and complete legal system design." Tang Minhao introduced that, on the whole, the background of the formulation of the law is closely related to the development trend of international medical apparatus supervision. In the global medical apparatus market, technological innovation and safety supervision are two key factors. In order to occupy a place in the international competition, our country must carry out systematic innovation in law, and promote the rapid progress of the industry from the legal system level while ensuring the quality and safety of medical apparatus products.
In terms of technological innovation, Xiang Rongwu, deputy director of the management office (presiding over the work) of the School of Modern Industry of Shenyang Pharmaceutical University and professor of medical apparatus management, said that with the rapid development of the medical apparatus industry in our country, it is necessary for our country to make comprehensive and systematic regulations on scientific and technological innovation, financial support, industry norms, industry-university-research connection, and life cycle management through the formulation of special laws to promote the high-quality scientific development of the medical apparatus industry. In addition, the formulation of special laws will help to connect with the international medical apparatus management legal system and give play to the influence of our country in relevant international organizations.
In terms of safety supervision, Song Hualin, dean of Nankai University Law School and director of Nankai University Medical and Health Law Research Center, believes that in the transition period, the legal system will inevitably lag behind the development of society. The current "Regulations on the Supervision and Administration of Medical Apparatus", as an administrative regulation, gives the administrative department too much discretion in terms of entities and procedures, and the regulations on supervision methods and supervision procedures are not detailed enough. The setting of legal responsibilities is relatively crude and the rigor is insufficient. Its role is no longer in line with the actual development of the current medical apparatus industry. It fails to fully follow the whole process of high-risk health product supervision, or design the corresponding regulatory structure and framework according to the logic of risk supervision.
