Blockbuster! The Draft Medical Device Management Law Released

Since 28 August, the Comprehensive Department of the NMPA has been publicly soliciting opinions on the ‘Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Opinion)’ (hereinafter referred to as the ‘Draft for Opinion’), with a deadline of 28 September 2024 for feedback.

The Draft for Opinion on the official website consists of eleven chapters and 190 articles, covering various aspects such as medical device research and development, production, operation, use, standards, classification, warning, and recall. It encourages innovation while strengthening full lifecycle supervision. In addition, the‘Draft for Opinion also mentions keywords such as medical device industry fund and products going overseas…This is the first time that the Medical Devices Management Law has been included in the legislative planning, and the whole life-cycle regulatory work has been made a priority. The document emphasises:

– Medical device registrant, the legal representative of the filer, the main person in charge of the quality of medical devices is fully responsible.

– Local people’s governments at or above the county level shall incorporate the supervision and management of medical devices into the national economic and social development planning at this level, include the funds for the supervision and management of medical devices in the budget of the government at this level, and strengthen the review of medical devices, inspection, examination, vigilance, inspection and law enforcement capacity building, and provide protection for the supervision and management of medical devices.

– The State supports scientific research and application of medical device regulation, encourages the combination of regulatory science with higher education and industrial development, innovates regulatory tools, standards and methods, and promotes the modernisation of the medical device regulatory system and regulatory capacity.

Previously, because China’s medical device field is only subject to regulatory control, there is no legal restrictions, so the relevant penalties do not play a sufficient deterrent effect. The Medical Devices Management Law has changed the term ‘violation’ to ‘offence’. The Draft for Opinion stresses that, if a violation of the provisions of this Law constitutes an offence, criminal responsibility shall be investigated in accordance with the law. Chapter 10 “Legal Responsibilities” of the document specifies the corresponding punishments for illegal behaviors of medical device manufacturers, operators, clinical trial institutions, and users. After the official promulgation of the Medical Device Management Law, the supervision of the entire product lifecycle will be further strengthened. The Draft for Opinion also mentions keywords such as medical device innovation, clinical value, and going global.

– Innovation

As of now, NMPA has approved 292 innovative medical devices. The draft for soliciting opinions once again emphasizes the importance of innovation: the country will improve the medical device innovation system, strengthen basic research and applied research, and increase efforts to tackle original leading technologies and key core technologies. The state formulates plans and policies for the medical device industry, including the research and innovation of medical devices as a development priority, and provides support in areas such as technology projects, financing, credit, bidding and procurement, and medical insurance. The state establishes a medical device industry development fund to promote the innovation and development of high-performance and high-quality medical devices, so as to encourage the cooperation between financial funds and social capital and broaden the financing channels of medical device enterprises. In addition, the Draft for Opinion also mentions that the state supports the construction of disciplines in the field of medical devices, accelerates the cultivation of compound and skilled medical device technology talents and management talents.

– Clinical value

The Draft for Opinion also emphasizes the importance of the clinical value of medical devices. The state supports the development of medical devices guided by clinical value, using new technologies, processes, methods, and materials; Encourage innovation in the development of medical devices for rare diseases and diseases that pose a serious threat to life and for which there is currently no effective treatment, and improve product supply capacity. The state encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out innovative research on traditional Chinese medicine medical devices. The country promotes the coordinated development and governance of healthcare, medical insurance, and pharmaceuticals, improves policies such as bidding and procurement, medical fees, and medical insurance, and supports the clinical promotion and use of innovative medical devices. Encourage medical institutions to prioritize the procurement and use of innovative medical devices.

–International market expansion

Article 19 of the Draft for Opinions clearly supports medical device enterprises in exploring international markets, encourages third-party institutions to establish and improve service guarantee systems for import and export legal consultation, testing, certification, intellectual property, etc., and promotes the international development of the industry.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：www.yaozh.com

Translated & edited： Bradyknow