The National Medical Products Administration of China (“NMPA”) has recently released the Medical Device Administration Law of the People’s Republic of China (Draft for Comments) (hereinafter referred to as the “Draft for Comments”) to solicit opinions from society. Consisting of 190 articles in 11 chapters, the Draft for Comments covers aspects such as medical device R&D, production, operation, use, standards, classification, vigilance, and recall, being the rudiment of China’s first fundamental law in the field of medical device administration.
Medical devices are closely related to people’s lives and health, the quality, safety, and innovative development of which have attracted great attention from the CPC Central Committee and the State Council. As China’s first fundamental law in the field of medical device administration, the enactment of the Medical Device Administration Law is highly anticipated. Adhering to a people’s health-centered approach, the Draft for Comments encourages innovation, follows the laws of scientific regulation, highlights problem orientation and international perspectives, and further improves the medical device administration system, to promote the high-quality development of the medical device industry.
According to the Draft for Comments, the basic principle of medical device administration is that medical device administration should be centered on people’s health and should establish a concept of safe development, follow the principles of risk management, whole-process control, scientific regulation, and social co-governance, and ensure the safety, effectiveness, and accessibility of medical devices.
The Draft for Comments implements the latest decisions and arrangements of the CPC Central Committee and the State Council to encourage and support the innovation and high-quality development of the medical device industry, strives to solidify the achievements of medical device review and approval system reforms in recent years, and, on this basis, further enriches the content encouraging innovation. Its general provisions propose that China improves the medical device innovation system, formulates medical device industry plans and policies, and supports the clinical promotion and use of innovative medical devices, and its subsequent chapters give specific provisions on the special review, priority review and approval, emergency approval, emergency use, and conditional approval of medical devices, encourage international multicenter clinical trials, and emphasize the comprehensive improvement in review and approval capabilities.
The Draft for Comments further optimizes and improves related medical device administration systems to meet the needs of medical device regulation and industry development. For example, it provides top-level design for the management of medical device standards and optimizes the management system thereof; it establishes a dedicated chapter on medical device import and export, to optimize management systems and accelerate the “bringing in” and “going global” of the medical device industry; drawing on international experience, it proposes that China establish a national medical device vigilance system that expands the scope of monitoring, identification, assessment, and control from adverse events of medical devices to various harmful events related to the use of medical devices that cause or may cause bodily harm.
In terms of supervision and administration, the Draft for Comments involves establishing a professional system of medical device reviewers, inspectors, testers, vigilance officers, and auditors and implementing a unified system for releasing medical device safety information and a medical device reserve system. Furthermore, the Draft for Comments also considers improving the legal liability system for medical devices, with related provisions for exemption from punishment for obligation performance, heavier punishments, and exemption from liability for duty fulfillment as well as related requirements for the legal liabilities of actual controllers of enterprises and operators of e-commerce platforms.
“The enactment of the Medical Device Administration Law can elevate the legal level of medical device administration, establish the core legal system for medical device regulation, further strengthen the systematicness of medical device regulations and policies, effectively integrate basic rules for industrial development, standardize basic requirements for government regulation and law enforcement, and enhance the uniformity and coordination of regulation,” said Tang Minhao, Lead Researcher of the Shanghai Association of Food & Drug Safety, believing that the Draft for Comments fully reflects the characteristics of professional administration of medical devices, explores scientific regulation and institutional innovation, draws on international experience, takes into account China’s development requirements, and focuses on optimizing and improving the medical device administration system.
According to Wang Xinbing, Regulatory Director of Shenzhen Mindray Bio-Medical Electronics Co., Ltd., the Draft for Comments responds to hot issues of concern to the industry and promotes their solutions. “To transition China’s medical device industry from a large one to a strong one and accelerate its innovative development, the support of high-level laws is required.” He stated that the Medical Device Administration Law cannot only solidify effective reform measures in recent years into law for them to exert greater effectiveness but also coordinate with laws in other fields to help solve practical problems facing the medical device industry at present, thereby further promoting the industry’s high-quality development.
It is reported that the deadline for this solicitation of opinions is September 28, 2024. During the solicitation period, all sectors of society can actively provide opinions and suggestions. The NMPA will carefully study and take them and, for concentrated concerns, will organize symposiums and special studies and demonstrations.
News link: Medical Device Administration Law of the People’s Republic of China (Draft for Comments)
Source: CMDE
Medical devices are closely related to people’s lives and health, the quality, safety, and innovative development of which have attracted great attention from the CPC Central Committee and the State Council. As China’s first fundamental law in the field of medical device administration, the enactment of the Medical Device Administration Law is highly anticipated. Adhering to a people’s health-centered approach, the Draft for Comments encourages innovation, follows the laws of scientific regulation, highlights problem orientation and international perspectives, and further improves the medical device administration system, to promote the high-quality development of the medical device industry.
According to the Draft for Comments, the basic principle of medical device administration is that medical device administration should be centered on people’s health and should establish a concept of safe development, follow the principles of risk management, whole-process control, scientific regulation, and social co-governance, and ensure the safety, effectiveness, and accessibility of medical devices.
The Draft for Comments implements the latest decisions and arrangements of the CPC Central Committee and the State Council to encourage and support the innovation and high-quality development of the medical device industry, strives to solidify the achievements of medical device review and approval system reforms in recent years, and, on this basis, further enriches the content encouraging innovation. Its general provisions propose that China improves the medical device innovation system, formulates medical device industry plans and policies, and supports the clinical promotion and use of innovative medical devices, and its subsequent chapters give specific provisions on the special review, priority review and approval, emergency approval, emergency use, and conditional approval of medical devices, encourage international multicenter clinical trials, and emphasize the comprehensive improvement in review and approval capabilities.
The Draft for Comments further optimizes and improves related medical device administration systems to meet the needs of medical device regulation and industry development. For example, it provides top-level design for the management of medical device standards and optimizes the management system thereof; it establishes a dedicated chapter on medical device import and export, to optimize management systems and accelerate the “bringing in” and “going global” of the medical device industry; drawing on international experience, it proposes that China establish a national medical device vigilance system that expands the scope of monitoring, identification, assessment, and control from adverse events of medical devices to various harmful events related to the use of medical devices that cause or may cause bodily harm.
In terms of supervision and administration, the Draft for Comments involves establishing a professional system of medical device reviewers, inspectors, testers, vigilance officers, and auditors and implementing a unified system for releasing medical device safety information and a medical device reserve system. Furthermore, the Draft for Comments also considers improving the legal liability system for medical devices, with related provisions for exemption from punishment for obligation performance, heavier punishments, and exemption from liability for duty fulfillment as well as related requirements for the legal liabilities of actual controllers of enterprises and operators of e-commerce platforms.
“The enactment of the Medical Device Administration Law can elevate the legal level of medical device administration, establish the core legal system for medical device regulation, further strengthen the systematicness of medical device regulations and policies, effectively integrate basic rules for industrial development, standardize basic requirements for government regulation and law enforcement, and enhance the uniformity and coordination of regulation,” said Tang Minhao, Lead Researcher of the Shanghai Association of Food & Drug Safety, believing that the Draft for Comments fully reflects the characteristics of professional administration of medical devices, explores scientific regulation and institutional innovation, draws on international experience, takes into account China’s development requirements, and focuses on optimizing and improving the medical device administration system.
According to Wang Xinbing, Regulatory Director of Shenzhen Mindray Bio-Medical Electronics Co., Ltd., the Draft for Comments responds to hot issues of concern to the industry and promotes their solutions. “To transition China’s medical device industry from a large one to a strong one and accelerate its innovative development, the support of high-level laws is required.” He stated that the Medical Device Administration Law cannot only solidify effective reform measures in recent years into law for them to exert greater effectiveness but also coordinate with laws in other fields to help solve practical problems facing the medical device industry at present, thereby further promoting the industry’s high-quality development.
It is reported that the deadline for this solicitation of opinions is September 28, 2024. During the solicitation period, all sectors of society can actively provide opinions and suggestions. The NMPA will carefully study and take them and, for concentrated concerns, will organize symposiums and special studies and demonstrations.
News link: Medical Device Administration Law of the People’s Republic of China (Draft for Comments)
Source: CMDE