Life Sciences Horizons Brochure 2025 - Flipbook - Page 77
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2025 Horizons Life Sciences and Health Care
China’s draft medical devices law unveiled
On 28 August 2024, the National Medical Products
Administration, China’s equivalent of the U.S. Food
and Drug Administration, issued the Medical Device
Administration Law (Draft for Comments) (the “Draft
MDL”) for public consultation. This marks a significant
legislative upgrade for the sector, elevating medical
device regulation from lower-level administrative rules
issued by the industry regulator to the much higher
status of formal law, reflecting the industry’s rapid
growth, the need for a modernized regulatory
framework, and perhaps, a reflection of the many
compliance issues identified in the sector in recent
years. Below is an overview of the notable
developments introduced by the Draft MDL.
Redesign of domestic agent system
Support for medical device innovation
Under the Draft MDL, the “domestic agent” system for imported
devices is to be revamped, with the former agent now renamed
“domestic responsible person” (in Chinese: 境内责任人). Article 88
of the Draft MDL bolsters the agent’s compliance obligations for
imported devices, making them jointly liable with the overseas
registrant. This shift strengthens oversight and ensures greater
accountability in product quality and compliance management
for imported devices.
The Draft MDL emphasizes innovation, promoting
interdisciplinary research and collaboration among companies,
universities, and medical facilities. It codifies the special review
process for innovative devices and encourages coordinated
development across health care, insurance, and pharmaceutical
sectors to support adoption.
Establishment of medical device vigilance system
Penalties for violations are significantly increased, with higher
fines and the introduction of administrative detention for severe
offenses, such as unauthorized manufacturing of Class II or
III devices.
Article 107 of the Draft MDL introduces a medical device vigilance
system to monitor adverse events and other harmful incidents,
aligning China’s approach with international standards. The
expanded scope includes quality issues and device interactions,
emphasizing proactive risk management.
Transferability of registration certificates
Encouragement of multi-center clinical trials
Addressing a long-standing gap in the current regulations, the
Draft MDL expressly permits the transfer of a medical device
registration certificate. Article 58 of the Draft MDL allows the
registrant to transfer a certificate subject to obtaining regulatory
approval; provided the transferee meets safety, quality, and risk
control standards. This change will facilitate industry
consolidation – providing new structuring options by way of asset
transfer, rather than share deal – and enhance operational
efficiency allowing companies to fine tune their portfolios by way
of exchange or transfer to meet changing market demand.
The Draft MDL streamlines multi-center clinical trials within
China, allowing participating institutions to carry out abbreviated
ethics reviews after the lead institution has given its approval. It
also encourages international trials, and provides for accepting
foreign data that meets Chinese registration requirements,
thereby fostering global collaboration.
Increased penalties
The Draft MDL reflects China’s commitment to “high-quality
development” in its medical device sector. While the changes
present compliance challenges and costs, they also offer
opportunities for companies that proactively adapt, as it may
remove from the market those who cannot or will not meet the
new requirements.
Andrew McGinty
Partner
Hong Kong
Wensheng Ren
Counsel
Hogan Lovells Fidelity
Life Sciences
and Healthcare:
Foreign Firms
Firm of the Year
Legal 500, 2024
