Last September, the Overarching Regulation of Medical Devices - Medical Device Administration Law was added to the legislative agenda. After 11 months of development, on August 28, 2024, China's National Medical Products Administration (NMPA) released the Draft for Comments on the Medical Device Administration Law (hereinafter referred to as "the Draft") for public consultation. The deadline for submitting feedback is September 28.
The Draft covers multiple stages of the medical device’s lifecycle, including research and development, manufacturing, distribution, and usage, along with standards, classification, safety monitoring, and recall procedures. It places particular emphasis on enhancing regulatory oversight throughout the entire lifecycle of medical devices and fostering innovation.
Enhancing Regulatory Oversight Throughout the Entire Lifecycle of Medical Devices
The Draft highlights the importance of regulating the entire lifecycle of medical devices, encompassing stages such as research and development, manufacturing, distribution, usage, as well as import and export.
Optimizing Standards Management: The Draft proposes the establishment of National Medical Device Standards Committee, tasked with formulating and implementing mandatory national standards for medical devices. The Draft also suggests establishing a mechanism for evaluating the implementation of these standards, with prompt revisions based on the findings.
Defining Accountability: The Draft specifies that the legal representatives and key persons in charge of medical device registrants and notifiers bear full responsibility for the quality of the devices. It also emphasizes the role of domestic representatives, making them jointly responsible together with registrants and notifiers for establishing quality management systems and conducting post-market management.
Implementing a Unique Device Identification (UDI) System: The Draft proposes establishing standardized rules for Unique Device Identification (UDI) and recommends a phased approach to UDI implementation based on the risk associated with different medical devices. All stakeholders are required to comply with the UDI system to ensure that UDI information is accurate, complete, and traceable.
Regulating Online Sales: The Draft stipulates that entities conducting online sales of medical devices must be registered or notified medical device enterprises and must report their online sales activities to the competent authorities (with some exceptions for specific device categories). Webpages for online sales must clearly display their registration certificates, business licenses, or notification information and keep this information updated. E-commerce platforms must register with the competent authorities and make their registration information publicly available. Additionally, they must verify and record the credentials of platform operators and maintain the records of all verification, registration, and sales activities.
Establishing a Vigilance System: Drawing on international practices, the Draft proposes establishing a vigilance system for medical devices. This system will expand the scope of monitoring, identifying, assessing, and controlling adverse events related to medical devices to cover other harmful events that may cause harm to individuals.
Improving the Legal Responsibility Framework: The Draft enhances the legal responsibility framework for medical devices by introducing stricter penalties for violations. It outlines corresponding punishments for failing to meet obligations and sets specific rules for exemptions and heavier penalties. It also includes very detailed and stringent requirements for the recall systems of non-compliant products and for monitoring and handling adverse events.
Fostering Innovation
In accordance with China's aim to improve its medical device innovation system, the Draft introduces various measures to support this goal:
Fostering Interdisciplinary Research: The Draft promotes collaborative research across diverse fields, including life sciences, materials science, applied sciences, information science, and medical science. The aim is to drive technological advancements in medical devices and enhance the transition of scientific discoveries into industrial applications.
Empowering Enterprises: The Draft highlights the importance of enterprises as key drivers of technological innovation. It encourages companies to establish or collaborate in the creation of research institutions, and supports partnerships between businesses, universities, research centers, and healthcare facilities for the development and innovation of medical devices. Additionally, it advocates for stronger brand development and more protection of intellectual property rights within companies.
Strengthening Talent Development and Exchange: The Draft emphasizes the need to accelerate the training of multidisciplinary and skilled professionals in the field of medical device technology and management. It also encourages academic exchanges within the medical device industry, facilitated by industry associations.
Offering Financial and Policy Support: The Draft proposes to provide support in areas such as scientific research funding, financing, credit, procurement, and health insurance. It proposes the establishment of a medical device industry development fund to stimulate innovation in high-performance and high-quality devices. The Draft also proposes to promote public-private partnerships to broaden financing options for medical device companies and supports coordinated development in healthcare, health insurance, and pharmaceuticals. Improvements in procurement, medical billing, and insurance policies are also suggested as part of the path heading to the clinical adoption of innovative devices.
Improving Review and Approval Processes: The Draft advocates for the development of medical devices utilizing new technologies, processes, methods, and materials, particularly those with significant clinical value. It encourages innovation in devices aimed at rare diseases and serious life-threatening conditions that lack effective treatments. Specific provisions regulate special reviews, priority reviews, emergency approvals, urgent use, and conditional approvals.
ChemLinked Comments
The Medical Device Administration Law replaces the Regulations on the Supervision and Administration of Medical Devices, which was administrative regulations with limited legal strength. The new law, passed by the National People's Congress, brings enhanced legal weight and enforcement power. It addresses previous legal gaps and improves the regulatory framework, providing a more robust legal basis and support for the industry's development. The introduction of the new law marks the beginning of stricter regulatory oversight while offering clearer guidance for innovation, research and development, as well as market entry in the medical device sector.
