In accordance with Administrative Measures for Registration and Record-Filing of Medical Devices, the National Medical Products Administration (NMPA) released a 2025 edition of its Catalogue of Medical Devices Exempted from Clinical Evaluation on 13 May. The catalogue replaced the 2023 edition and took effect on the same day. The new edition covers 1,047 medical devices exempted from clinical evaluation. Of these, 28 are new additions. These include personalised 3D-printed surgical models, delivery-type intracranial balloon dilatation catheters and non-invasive ambulatory blood pressure monitors. There are also 25 “product description revisions”, three “product name revisions” and two “product name and description revisions”. The Catalogue of Medical Devices Exempted from Clinical Evaluation (2025 Edition) is available on the NMPA’s website at https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20250513095643145.html
On 8 May, the National Health Commission released its Geriatric Medicine Department Establishment and Management Guide (2025 Edition), which took effect on the same day. The document provides guidelines for the establishment and operation, staffing and management of such departments. The guide specifies that departments of geriatric medicine shall have venues, facilities, equipment, medicines and technical capabilities commensurate with the level, functions and tasks of their medical institutions. General hospitals shall ensure the sustainable development of geriatrics and form stable geriatric medical teams with specific duties for all posts to provide safe and effective medical services for the elderly. Departments of geriatric medicine shall make standardised and comprehensive geriatric assessments and formulate and implement palliative care plans for elderly patients as well as prevention and treatment plans in relation to falls, pressure injuries and aspiration. The department shall also implement patient safety measures specifically for elderly people in accordance with institutions’ overall safety requirements and industrial standards in relation to patient activity areas, as well as sitting and sleeping facilities.
A Canadian medtech firm views Hong Kong as a strategic entry point to the broader Asian markets for its tremor-reducing technology. The region's ageing population and favourable reimbursement pathways contribute to the demand for assistive devices. Emile Maamary, co-founder and CMO of Steadiwear, discussed with HKTDC Research their business model, which leverages the strengths of collaboration between Toronto, Hong Kong and Mainland China.
The Quality Management Rules on Online Sales of Medical Devices, released by the National Medical Products Administration on 28 April, will take effect on 1 October. These rules apply to online sellers of medical devices, as well as operators of online marketplaces facilitating relevant online transactions. The document specifies that online sellers should establish a quality management unit commensurate with their scope of online sales, mode of operation and scale of sales. Besides discharging the duties listed in the Quality Management Rules on Medical Device Business, the unit shall also supervise relevant departments and staff members in following the rules relating to online sales of medical devices. Moreover, it shall organise and formulate a quality management system for online sales, guide and supervise the implementation of such a system, and inspect, rectify and continuously improve on its implementation. Online sellers shall display the specified qualifications information on their website or business homepage and provide necessary information or reminders on product pages.
In a move that the FDA said “marks a new era in FDA enforcement,” the agency has announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for U.S. consumers and patients.