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2024 is coming to an end. This year, we have witnessed the development of medical device supervision: the prototype of the Medical Device Management Law of the People's Republic of China has taken shape, the work of consolidating and improving medical device safety has continued to deepen, the number of innovative medical devices approved for listing has reached a new high, and the standardization of medical devices has reached a new level...
Today, let's take stock of the top ten highlights of medical device supervision in 2024, strive to sort out the development trajectory of the medical device industry this year, and gain insight into the future development trend of the industry.
1. Public Solicitation of Comments on the "Medical Device Management Law of the People's Republic of China (Draft for Comments)"
On August 28, 2024, the State Food and Drug Administration publicly solicited opinions from the public on the "Medical Device Management Law of the People's Republic of China (Draft for Comments)" (hereinafter referred to as the "Draft for Comments"). The "Draft for Comments" has 11 chapters and 190 articles, covering all aspects of medical device research, production, operation, use, standards, classification, warnings and recalls. The prototype of the first fundamental law in the field of medical device management in my country has taken shape.
Comment: On September 7, 2023, the legislative plan of the 14th National People's Congress Standing Committee was released, and the Medical Device Management Law was included in it. As the first fundamental law in the field of medical device management in my country, the formulation of the Medical Device Management Law has attracted much attention. In the past year, the National Medical Products Administration has held nearly 20 seminars to collect and listen to opinions from all parties; carried out legislative research with the legislative organs in local areas to fully understand the development of the industry and the industry's call for the improvement of the legal and regulatory system for medical device supervision; held special work meetings and centralized draft revision meetings many times, repeatedly studied and discussed key issues, and continuously revised and improved the draft, which fully demonstrated the determination of the national drug supervision department to promote the high-quality development of the medical device industry with the rule of law. The rise of medical device management from administrative regulations to laws is not only to improve the legal status, but also to improve the quality of content. It will help to strengthen the systematicness of medical device regulations and policies, and enhance the unity and coordination of medical device supervision. We look forward to the early implementation of a new industry law.
2. The consolidation and improvement of medical device safety continues to deepen
In June 2023, the national drug supervision system launched the drug safety consolidation and improvement action. During the action, local drug regulatory authorities have taken a series of measures around "preventing risks, investigating cases, and improving capabilities", and have achieved remarkable results. In the field of medical devices, local drug regulatory authorities have taken the consolidation and improvement of medical device safety as a starting point to continuously strengthen dynamic supervision of quality and safety throughout the life cycle, effectively investigate and resolve safety risks, and ensure that the safety situation of medical devices is stable and improving.
Comment: Carrying out drug safety consolidation and improvement actions is an important starting point for continuously improving drug regulatory capabilities and an inevitable requirement for protecting the lives, health and safety of the people. In recent years, new technologies, new products, and new formats in the medical device industry have been integrated and emerging in an endless stream, bringing challenges to medical device supervision. Drug regulatory departments at all levels have taken the opportunity of promoting the consolidation and improvement of medical device safety to innovate regulatory mechanisms and methods, strengthen the risk investigation and rectification of key products such as centralized procurement and sterile implants, and key enterprises such as production entrusted by registrants, strengthen network monitoring and case investigation, continue to promote regulatory capacity building, strengthen risk consultation and problem handling, crack down on illegal and irregular activities, and protect medical device safety with hard measures with "teeth", which has effectively deterred illegal and criminal activities in medical device safety and effectively enhanced the people's sense of gain in the safety of medical devices.
