BEIJING—China’s National Medical Products Administration (NMPA) has unveiled a draft proposal for the “Medical Device Management Law of the People’s Republic of China,” seeking public input until September 28. The law aims to regulate the entire spectrum of medical device activities, from research to supervision, within the nation’s borders.
The draft emphasizes the government’s role in fostering the medical device sector, prioritizing research and innovation, and offering robust support through technology projects, financing, and medical insurance. A spotlight is placed on devices with clinical value, leveraging new technologies and materials, particularly those addressing rare diseases and life-threatening conditions without existing treatments.
The government is set to enforce a medical device registrant and filer system, assigning legal responsibility for device safety and efficacy throughout the product lifecycle. The State Council’s drug regulatory department, in tandem with the standardization administrative department, will establish the National Medical Device Standards Committee. This committee will spearhead the development and enforcement of medical device standards, engaging in international standardization efforts to synchronize Chinese standards with global counterparts.
Clinical trial approvals will undergo comprehensive analysis, with decisions communicated within a 30-day window. Innovative devices with patent-protected core technologies and significant clinical value will receive special review, alongside priority for devices targeting rare diseases and other urgent clinical needs. Emergency approvals will be facilitated for public health crises, with conditional approvals available for certain high-priority devices.
Overseas entities exporting Class II and III devices to China must appoint a Chinese legal representative with the necessary licenses to ensure compliance. For domestic operations, Class II device businesses require registration, while Class III operations necessitate a business license, both valid for five years.
Online sales of medical devices are to be conducted by registered entities, with e-commerce platforms verifying operator credentials to ensure legal compliance. Importation of devices for urgent clinical needs or rare disease treatment is permitted with State Council approval, with strict regulations for cross-border e-commerce retail imports.
Clinical application guidelines prioritize patient safety, efficacy, and cost-effectiveness, mandating proper staff training and adherence to treatment protocols. In extraordinary circumstances, physicians may utilize devices for off-label treatments supported by evidence-based medicine, following informed consent.
The government is reinforcing its supervisory framework with a dedicated team of evaluators and inspectors to oversee the medical device lifecycle. International inspections may be conducted for devices listed or planned for domestic introduction. Additionally, a medical device reserve system has been instituted to address emergencies, with local governments crafting contingency plans for device safety incidents.- Flcube.com
