On 28 August 2024, the National Medical Products Administration of China released a draft Medical Device Administration Law of China (“Draft Law”) to solicit opinions from the public until 28 September 2024. China’s medical device market has developed rapidly in recent years, and the export scale has especially grown. The Regulation on the Supervision and Administration of Medical Devices (“Regulation”) currently implemented in the medical device field can no longer fully and effectively meet the needs of such a rapidly developing market. The promulgation of the Draft Law has not only improved the status of relevant provisions in the Regulation but also added more new provisions to promote the high-quality development and more international exchanges and cooperation of China’s medical devices.
The Regulation revised in 2021 has 107 articles and eight chapters, including general provisions, registration and filing of medical device products, production of medical devices, operation and use of medical devices, handling of adverse events and recall of medical devices, supervision and inspection, legal liability and supplementary provisions. The chapters with the most articles are legal liability, operation and use of medical devices, and registration and filing of medical device products. The Draft Law has 190 articles and eleven chapters, adding chapters on medical device standards and classification, medical device development, import and export of medical devices, and medical device alert and recall. It retains general provisions, production of medical devices, supervision and management, legal liability, and supplementary provisions, and splits the chapter on operation and use of medical devices in the Regulation into two chapters of operation of medical devices and use of medical devices. The chapters with the most articles are supervision and management, legal liability, and development of medical devices. The Draft Law does not include the chapter on registration and filing of medical device products in the Regulation because it is the implementation rules that should continue to be retained in the Regulation. The following article focuses on the new content of the new chapters, retained chapters, and split chapters in the Draft Law.
The new chapters added to the Draft Law include chapters on medical device standards and classification, medical device development, import and export of medical devices, and medical device alert and recall. The chapter on medical device development is not only the chapter with the most new clauses but also the third most important chapter in the Draft Law. For the development of medical devices, the Draft Law requires that product risks and unexpected effects must be minimized and acceptable, and that product quality must be stable. The ethical review must be conducted for clinical trials of medical devices, the subjects must be informed of relevant risks and other situations, and written informed consent must be obtained from the subjects. In addition, the collection of personal information during the trial should comply with the provisions of the Personal Information Protection Law. For overseas clinical trials, the Draft Law requires that they be conducted in countries with clinical trial quality management and comply with relevant regulatory requirements for clinical trials of medical devices in China. It further stipulates that special review shall be implemented for innovative medical devices with core technology invention patents; priority review and approval shall be implemented for medical devices that diagnose or treat rare diseases, malignant tumors, and common diseases of the elderly or children; medical devices that are urgently needed for the treatment of rare diseases, serious life-threatening diseases that have no effective treatment methods, and for responding to public health events may be conditionally approved; and emergency approval can be implemented for medical devices that are needed for an emergency response to public health emergencies and have no similar products on the market in China, or the product supply cannot meet the needs of emergency response to public health emergencies.
The chapter on medical device standards and classification is the second largest chapter added to the Draft Law. According to the Draft Law, China’s medical device standards are divided into mandatory and recommended national standards. The former is aimed at technologies that protect human health and life safety and will be made public; and the latter is for technical requirements that meet basic general needs, match the mandatory national standard, and play a leading role in the medical device industry. China continues to implement the medical device registrant and recorder system to further connect with international common rules and create conditions for the international layout of Chinese medical device companies. In addition, this chapter also includes relevant provisions in terms of medical devices Class I to III in the Regulation.
The Draft Law adds a chapter on the import and export of medical devices. The Regulation does not involve relevant provisions on the import and export of medical equipment. It only mentions in the chapter on legal liability that illegal imports of medical devices shall be handled by the entry-exit inspection and quarantine agency. According to the Draft Law, China only allows the import of registered or recorded medical devices with Chinese instructions and Chinese labels. The domestic responsible person for imported medical devices is responsible for post-market risk management of imported medical devices, undertaking relevant adverse event monitoring and reporting, related investigation and disposal, organizing recalls, etc., and bears joint and several liabilities with the registrants and registrants of imported medical devices. With approval, a small amount of Class II and Class III medical devices can be imported for urgent clinical needs or diagnosis and treatment of rare diseases. After designating domestic enterprises in China as domestic service providers, enterprises engaged in cross-border e-commerce retail business are allowed to import medical devices in the catalog of medical devices allowed for imports. In addition, e-commerce platforms, websites, web pages, Internet applications, etc. are prohibited from providing information display, links, and other services for medical devices outside the catalog that are not registered or recorded in China.
The newly added chapter on medical device alert and recall, containing eight provisions, covers the provision on the handling of adverse events, product traceability, and recall system in the Regulation. According to the Draft Law, the medical device alert system is to monitor, identify, evaluate, and control medical device adverse events and other related injury events, which are occurred during the normal use of qualified medical devices. The handling of adverse events is one of the key contents of the chapter on the handling of adverse events and the recall of medical devices in the Regulation. Meanwhile, the Draft Law copies most of the provisions on the traceability and recall system in the Regulation.
The Draft Law retains the chapters on general provisions, production of medical devices, supervision and management, legal liability, and supplementary provisions. The chapter on legal liability is the key chapter with the most clauses both in the Regulation and the Draft Law. In the chapter, the Draft Law adds 15 new provisions. It stipulates that those who provide production and operation sites or other assistance to illegal operators will have their illegal gains confiscated and be fined between RMB 50,000 (Equivalent to US$ 7,050) and RMB 150,000 (Equivalent to US$ 21,150). The Draft Law lists four types of heavier penalties, including the production and sale of medical devices that are not registered or recorded and do not meet mandatory standards for pregnant women and children as the main users, and the production and sale of high-risk implantable medical devices that are not registered or do not meet mandatory standards. Giving or receiving kickbacks or other improper benefits in the purchase and sale of medical devices will result in the confiscation of illegal gains and a fine of between RMB 300,000 (Equivalent to US$ 42,300) and RMB 3 million (Equivalent to US$ 0.423 million). In serious cases, business licenses, approval documents, production licenses, operating licenses, etc. will be revoked. Those who bribe state officials in the development, production, and operation of medical devices will be banned from engaging in medical device production and operation activities for life. The penalty for the operator of the medical device e-commerce platform who fails to perform the obligations such as qualification review is to confiscate the illegal gains and impose a fine of not less than RMB 200,000 (Equivalent to US$ 28,200) but not more than RMB 2 million (Equivalent to US$ 0.282 million). If the circumstances are serious, the operator shall be ordered to suspend business for rectification and be fined not less than RMB 2 million (Equivalent to US$ 0.282 million) but not more than RMB 5 million (Equivalent to US$ 0.705 million). Meanwhile, the Draft Law stipulates that the relevant responsible persons who illegally produce, operate, import, use medical devices, provide false information, or take other deceptive means when applying for administrative licenses for medical devices may be detained for not less than 5 days but not more than 15 days if the circumstances are serious.
The chapter on supervision and inspection is the chapter with the most expanded clauses. The Draft Law adds new content to the chapter on supervision and management and expands the provisions in the Regulation. The new content includes allowing overseas inspections for overseas research and production-related processes of medical devices that have been marketed or are to be marketed; establishing a regulatory credit file system for medical device registrants, recorders, manufacturers, operating companies, domestic responsible persons for imported medical devices, and users; strengthening supervision and inspection of domestic responsible persons for imported medical devices; establishing a medical device decision-making expert advisory committee to provide decision-making consultation on technical matters such as medical device technical review, audit inspection, classification judgment, and quality inspection; and establishing national and local medical device reserves to urgently call for medical devices for major disasters, epidemics or other emergencies. Article 68 of the Regulation stipulates the establishment of a professional and specialized inspector system to strengthen the supervision and inspection of medical devices. The Draft Law not only expands the personnel of the system, including inspectors, testers, guards, and auditors, but also changes the inspection object of the system to the quality supervision and management of the entire life cycle of medical devices. In addition, the Draft Law changes the key supervision and inspection items pointed out in the Regulation, including the development and production of sterile, implantable, and other high-risk medical devices; new establishment or major changes in production and operation conditions; commissioned production of medical devices, etc.
The chapter on general provisions in the Draft Law has been increased from 12 articles to 19 articles. On the one hand, the Draft Law has added new provisions. For example, it states that China encourages the development and innovation of medical devices for rare diseases and serious life-threatening diseases; encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out innovative research on Chinese medicine medical devices; encourages international exchanges on medical device science and technology innovation, and strengthens international cooperation in medical device supervision. On the other hand, the relevant provisions in the Regulation have been revised. In terms of encouraging innovation, the Draft Law has added specific encouragement directions, such as “strengthening basic research and applied research and increasing the public relations efforts of original leading science and technology and key core technologies. Encourage cross-disciplinary research in scientific fields such as life sciences, materials sciences, and applied sciences, promote technological progress in medical devices and their raw materials and components, and improve the transformation of scientific and technological achievements and industrial levels”. In terms of industrial planning and policies, the Draft Law has also included research and development as a key development target. Medical device research and innovation will be supported by science and technology project establishment, financing, credit, bidding and procurement, and medical insurance.
In the chapter on the production of medical devices, the Draft Law only adds one clause but adds new requirements for relevant personnel and/or enterprises in medical device production. For relevant personnel, it requires the establishment of health records for staff who are engaged in work that affects product quality. For relevant enterprises, it requires the establishment of supplier review and raw material procurement acceptance systems for strengthening procurement management; the establishment of production process control procedures to clarify requirements for relevant personnel, equipment, processes, and environment; the establishment of product release procedures to clarify release standards and conditions; and the establishment of a record management system to ensure that the records are true, accurate, complete and traceable.
The Draft Law divides the chapter on the operation and use of medical devices in the Regulation into two chapters, namely the chapter on the operation of medical devices and the chapter on the use of medical devices. In the chapter on the operation of medical devices, the new contents mainly include several requirements. It requires that medical device operators establish a medical device quality management system and implement a medical device transportation and storage system; medical device network sales operators should publicize their medical device registration certificates, business licenses, or filing information on their websites; e-commerce platform operators that provide services for medical device network transactions should file information on their websites during the continuous public display period and record their fulfillment of legal obligations; and an online transaction monitoring platform should be established to monitor and deal with the online sales and transactions of medical devices. In the chapter on the use of medical devices, the new contents also include the requirements for medical device users to establish a medical device quality and use a behavior management system and a storage management system, to inform patients of the relevant matters of the clinical use of medical devices, and record the inspection, testing, calibration, maintenance, maintenance, and repair of medical devices. In addition, it stipulates that qualified medical institutions can customize medical devices for patients with rare diseases, and before use, they should file them and inform patients of relevant information.
In conclusion, the Draft Law supplements and improves the Regulation with a focus on encouraging innovation, promoting high-quality development, strengthening supervision, and expanding international exchanges. The formulation of the Draft Law has enhanced the legal status of medical device management and is conducive to the implementation of relevant policies.
The Regulation revised in 2021 has 107 articles and eight chapters, including general provisions, registration and filing of medical device products, production of medical devices, operation and use of medical devices, handling of adverse events and recall of medical devices, supervision and inspection, legal liability and supplementary provisions. The chapters with the most articles are legal liability, operation and use of medical devices, and registration and filing of medical device products. The Draft Law has 190 articles and eleven chapters, adding chapters on medical device standards and classification, medical device development, import and export of medical devices, and medical device alert and recall. It retains general provisions, production of medical devices, supervision and management, legal liability, and supplementary provisions, and splits the chapter on operation and use of medical devices in the Regulation into two chapters of operation of medical devices and use of medical devices. The chapters with the most articles are supervision and management, legal liability, and development of medical devices. The Draft Law does not include the chapter on registration and filing of medical device products in the Regulation because it is the implementation rules that should continue to be retained in the Regulation. The following article focuses on the new content of the new chapters, retained chapters, and split chapters in the Draft Law.
The new chapters added to the Draft Law include chapters on medical device standards and classification, medical device development, import and export of medical devices, and medical device alert and recall. The chapter on medical device development is not only the chapter with the most new clauses but also the third most important chapter in the Draft Law. For the development of medical devices, the Draft Law requires that product risks and unexpected effects must be minimized and acceptable, and that product quality must be stable. The ethical review must be conducted for clinical trials of medical devices, the subjects must be informed of relevant risks and other situations, and written informed consent must be obtained from the subjects. In addition, the collection of personal information during the trial should comply with the provisions of the Personal Information Protection Law. For overseas clinical trials, the Draft Law requires that they be conducted in countries with clinical trial quality management and comply with relevant regulatory requirements for clinical trials of medical devices in China. It further stipulates that special review shall be implemented for innovative medical devices with core technology invention patents; priority review and approval shall be implemented for medical devices that diagnose or treat rare diseases, malignant tumors, and common diseases of the elderly or children; medical devices that are urgently needed for the treatment of rare diseases, serious life-threatening diseases that have no effective treatment methods, and for responding to public health events may be conditionally approved; and emergency approval can be implemented for medical devices that are needed for an emergency response to public health emergencies and have no similar products on the market in China, or the product supply cannot meet the needs of emergency response to public health emergencies.
The chapter on medical device standards and classification is the second largest chapter added to the Draft Law. According to the Draft Law, China’s medical device standards are divided into mandatory and recommended national standards. The former is aimed at technologies that protect human health and life safety and will be made public; and the latter is for technical requirements that meet basic general needs, match the mandatory national standard, and play a leading role in the medical device industry. China continues to implement the medical device registrant and recorder system to further connect with international common rules and create conditions for the international layout of Chinese medical device companies. In addition, this chapter also includes relevant provisions in terms of medical devices Class I to III in the Regulation.
The Draft Law adds a chapter on the import and export of medical devices. The Regulation does not involve relevant provisions on the import and export of medical equipment. It only mentions in the chapter on legal liability that illegal imports of medical devices shall be handled by the entry-exit inspection and quarantine agency. According to the Draft Law, China only allows the import of registered or recorded medical devices with Chinese instructions and Chinese labels. The domestic responsible person for imported medical devices is responsible for post-market risk management of imported medical devices, undertaking relevant adverse event monitoring and reporting, related investigation and disposal, organizing recalls, etc., and bears joint and several liabilities with the registrants and registrants of imported medical devices. With approval, a small amount of Class II and Class III medical devices can be imported for urgent clinical needs or diagnosis and treatment of rare diseases. After designating domestic enterprises in China as domestic service providers, enterprises engaged in cross-border e-commerce retail business are allowed to import medical devices in the catalog of medical devices allowed for imports. In addition, e-commerce platforms, websites, web pages, Internet applications, etc. are prohibited from providing information display, links, and other services for medical devices outside the catalog that are not registered or recorded in China.
The newly added chapter on medical device alert and recall, containing eight provisions, covers the provision on the handling of adverse events, product traceability, and recall system in the Regulation. According to the Draft Law, the medical device alert system is to monitor, identify, evaluate, and control medical device adverse events and other related injury events, which are occurred during the normal use of qualified medical devices. The handling of adverse events is one of the key contents of the chapter on the handling of adverse events and the recall of medical devices in the Regulation. Meanwhile, the Draft Law copies most of the provisions on the traceability and recall system in the Regulation.
The Draft Law retains the chapters on general provisions, production of medical devices, supervision and management, legal liability, and supplementary provisions. The chapter on legal liability is the key chapter with the most clauses both in the Regulation and the Draft Law. In the chapter, the Draft Law adds 15 new provisions. It stipulates that those who provide production and operation sites or other assistance to illegal operators will have their illegal gains confiscated and be fined between RMB 50,000 (Equivalent to US$ 7,050) and RMB 150,000 (Equivalent to US$ 21,150). The Draft Law lists four types of heavier penalties, including the production and sale of medical devices that are not registered or recorded and do not meet mandatory standards for pregnant women and children as the main users, and the production and sale of high-risk implantable medical devices that are not registered or do not meet mandatory standards. Giving or receiving kickbacks or other improper benefits in the purchase and sale of medical devices will result in the confiscation of illegal gains and a fine of between RMB 300,000 (Equivalent to US$ 42,300) and RMB 3 million (Equivalent to US$ 0.423 million). In serious cases, business licenses, approval documents, production licenses, operating licenses, etc. will be revoked. Those who bribe state officials in the development, production, and operation of medical devices will be banned from engaging in medical device production and operation activities for life. The penalty for the operator of the medical device e-commerce platform who fails to perform the obligations such as qualification review is to confiscate the illegal gains and impose a fine of not less than RMB 200,000 (Equivalent to US$ 28,200) but not more than RMB 2 million (Equivalent to US$ 0.282 million). If the circumstances are serious, the operator shall be ordered to suspend business for rectification and be fined not less than RMB 2 million (Equivalent to US$ 0.282 million) but not more than RMB 5 million (Equivalent to US$ 0.705 million). Meanwhile, the Draft Law stipulates that the relevant responsible persons who illegally produce, operate, import, use medical devices, provide false information, or take other deceptive means when applying for administrative licenses for medical devices may be detained for not less than 5 days but not more than 15 days if the circumstances are serious.
The chapter on supervision and inspection is the chapter with the most expanded clauses. The Draft Law adds new content to the chapter on supervision and management and expands the provisions in the Regulation. The new content includes allowing overseas inspections for overseas research and production-related processes of medical devices that have been marketed or are to be marketed; establishing a regulatory credit file system for medical device registrants, recorders, manufacturers, operating companies, domestic responsible persons for imported medical devices, and users; strengthening supervision and inspection of domestic responsible persons for imported medical devices; establishing a medical device decision-making expert advisory committee to provide decision-making consultation on technical matters such as medical device technical review, audit inspection, classification judgment, and quality inspection; and establishing national and local medical device reserves to urgently call for medical devices for major disasters, epidemics or other emergencies. Article 68 of the Regulation stipulates the establishment of a professional and specialized inspector system to strengthen the supervision and inspection of medical devices. The Draft Law not only expands the personnel of the system, including inspectors, testers, guards, and auditors, but also changes the inspection object of the system to the quality supervision and management of the entire life cycle of medical devices. In addition, the Draft Law changes the key supervision and inspection items pointed out in the Regulation, including the development and production of sterile, implantable, and other high-risk medical devices; new establishment or major changes in production and operation conditions; commissioned production of medical devices, etc.
The chapter on general provisions in the Draft Law has been increased from 12 articles to 19 articles. On the one hand, the Draft Law has added new provisions. For example, it states that China encourages the development and innovation of medical devices for rare diseases and serious life-threatening diseases; encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out innovative research on Chinese medicine medical devices; encourages international exchanges on medical device science and technology innovation, and strengthens international cooperation in medical device supervision. On the other hand, the relevant provisions in the Regulation have been revised. In terms of encouraging innovation, the Draft Law has added specific encouragement directions, such as “strengthening basic research and applied research and increasing the public relations efforts of original leading science and technology and key core technologies. Encourage cross-disciplinary research in scientific fields such as life sciences, materials sciences, and applied sciences, promote technological progress in medical devices and their raw materials and components, and improve the transformation of scientific and technological achievements and industrial levels”. In terms of industrial planning and policies, the Draft Law has also included research and development as a key development target. Medical device research and innovation will be supported by science and technology project establishment, financing, credit, bidding and procurement, and medical insurance.
In the chapter on the production of medical devices, the Draft Law only adds one clause but adds new requirements for relevant personnel and/or enterprises in medical device production. For relevant personnel, it requires the establishment of health records for staff who are engaged in work that affects product quality. For relevant enterprises, it requires the establishment of supplier review and raw material procurement acceptance systems for strengthening procurement management; the establishment of production process control procedures to clarify requirements for relevant personnel, equipment, processes, and environment; the establishment of product release procedures to clarify release standards and conditions; and the establishment of a record management system to ensure that the records are true, accurate, complete and traceable.
The Draft Law divides the chapter on the operation and use of medical devices in the Regulation into two chapters, namely the chapter on the operation of medical devices and the chapter on the use of medical devices. In the chapter on the operation of medical devices, the new contents mainly include several requirements. It requires that medical device operators establish a medical device quality management system and implement a medical device transportation and storage system; medical device network sales operators should publicize their medical device registration certificates, business licenses, or filing information on their websites; e-commerce platform operators that provide services for medical device network transactions should file information on their websites during the continuous public display period and record their fulfillment of legal obligations; and an online transaction monitoring platform should be established to monitor and deal with the online sales and transactions of medical devices. In the chapter on the use of medical devices, the new contents also include the requirements for medical device users to establish a medical device quality and use a behavior management system and a storage management system, to inform patients of the relevant matters of the clinical use of medical devices, and record the inspection, testing, calibration, maintenance, maintenance, and repair of medical devices. In addition, it stipulates that qualified medical institutions can customize medical devices for patients with rare diseases, and before use, they should file them and inform patients of relevant information.
In conclusion, the Draft Law supplements and improves the Regulation with a focus on encouraging innovation, promoting high-quality development, strengthening supervision, and expanding international exchanges. The formulation of the Draft Law has enhanced the legal status of medical device management and is conducive to the implementation of relevant policies.