China enters new regulatory era with release of first draft Medical Devices Administration Law for Public Comment

On 28 August 2024, China’s National Medical Products Administration (NMPA) released the draft of the Medical Devices Administration Law of the People's Republic of China for public comment with the deadline for feedback set for 28 September 2024.

Unlike pharmaceutical products, for over two decades medical devices have not been governed by a national-level law from the National People's Congress, such as the Drug Administration Law, but by an administrative regulation, the Regulation on the Supervision and Administration of Medical Devices (i.e. "Medical Device Regulation"), and various separate administrative regulations, guidance, and notices.

This Draft Law represents China's first comprehensive legislation specifically governing the medical device industry. It consolidates scattered regulations related to medical devices into a unified legal framework and has been improved according to the latest trends in medical-device development and regulatory needs. Once finalised and enacted, the Draft Law is expected to provide new regulatory requirements and compliance guidance.

Key Points of the Draft Law

1. Enhanced approach for medical device standards and classification

Compared to the Medical Device Regulation, the Draft Law introduces a new chapter on medical device standards and classification, proposing that mandatory national standards for medical devices be established and made publicly available for free access. This chapter also addresses the need for regulatory adaptation. In particular, in recent years a large number of new types of medical devices have emerged that cannot be defined by traditional classification methods. The chapter explicitly states that the drug regulatory authority should provide medical device classification determination services to registrants and filers of medical devices, promptly disclose classification determination information, and adjust the classification catalogue. In addition, a medical device classification technical committee should be established to provide technical support for the management of medical device classification.

2. Regulating cross-border medical device business activities

The Draft Law consolidates and improves specific regulations for the import and export of medical devices, forming a separate chapter.

This chapter sets out specific requirements for the role of the "domestic responsible party", which will play a crucial role in ensuring compliance with Chinese regulations. The domestic responsible parties must obtain a medical device manufacturing/business licence and meet with the requirements of the registrants and the filers.  They will bear joint and several liability with the registrants and the filers. Overseas enterprises should carefully choose qualified domestic responsible parties to mitigate legal risks.

3. Implementing comprehensive legal responsibilities

The Draft Law significantly enhances the legal responsibilities of medical device enterprises. It introduces a multi-tiered system of civil, criminal, and administrative liabilities, expanding the scope of punishable offences and clarifying the roles of legal representatives and key personnel. These individuals will bear responsibility for the quality and safety of medical devices, as well as for the enterprises' production activities.

The increased legal responsibilities outlined in the Draft Law are expected to increase the importance of compliance, with stricter enforcement expected to elevate the risks and costs associated with regulatory violations.

4. Fostering innovation in the medical device sector

Finally, the Draft Law emphasises the importance of innovation within the medical device industry. Significant initiatives include:

• Supporting the establishment of R&D institutions and encouraging collaborative research between enterprises, universities, and medical institutions;
• Reducing the approval time for clinical trials of medical devices from 60 to 30 working days;
• Encouraging medical institutions to prioritise the purchase and use of innovative medical devices.

The Draft Law also proposes the creation of a medical device industry development fund to enhance financing opportunities by fostering cooperation between government financial resources and private capital. Recent developments in regions like Beijing, Shanghai, and Jiangsu, where substantial funds have been allocated to support pharmaceutical innovation, also signal a positive trend that could reduce R&D costs and stimulate further growth in the medical device industry.

In addition to the above key points, the Draft Law also provides for the transfer of product registration certificates, medical device vigilance and other systems. It, however, lacks specific implementation details, which are expected to be clarified in the final law or subsequent regulations.

Although the Draft Law is still in the consultation phase, it reflects a clear intent by Chinese authorities to promote innovation, enhance regulatory oversight, and ensure the highest standards of quality in the medical device industry. Medical device companies, both domestic and international, should closely monitor developments and prepare for potentially significant changes in compliance requirements once the law is finalised and implemented.

The original publication can be found here (Chinese only).

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