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

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.

Ground-breaking Hong Kong research project MagIC is using intestinal bacteria to tackle a number of debilitating, age-related health conditions.

President Trump issued on 12 May an executive order promising “aggressive action” if foreign countries and manufacturers do not lower prices for prescription drugs in the U.S.

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.

On 21 April, the National Medical Products Administration and the General Administration of Customs jointly announced the launch of a pilot programme for the use of imported calculus bovis in the production of proprietary Chinese medicines in 12 provincial-level regions, namely, Beijing, Tianjin, Hebei, Shanghai, Zhejiang, Jiangxi, Shandong, Hunan, Guangdong, Sichuan, Fujian and Guangxi. Under this programme, calculus bovis sourced from countries or regions not subject to mad cow disease import bans and compliant with China’s customs quarantine and pharmaceutical quality inspection requirements will be permitted for trial use in the manufacturing of proprietary Chinese medicines. The programme will continue for two years and the use of imported calculus bovis will be progressively expanded nationwide after two years upon evaluation. Applicants for the import of calculus bovis should be drug marketing authorisation holders for proprietary Chinese medicines containing calculus bovis. Detailed requirements are outlined to ensure the quality and safety of calculus bovis, the traceability of imports, and the integrity of processing and production procedures.

President Trump on 5 May issued two executive orders aimed at promoting the domestic production of critical medicines and improving the safety and security of biological research. In addition, the president has instructed senior officials to immediately begin the process of instituting a 100 percent tariff on foreign movies.

In order to speed up the development of the Shenzhen Park area of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone (Hetao Shenzhen Park) into an “international high ground” for science and technology innovation, the Guangdong provincial government announced on 18 April its decision to entrust Shenzhen to exercise eight provincial-level administrative duties in relation to the Hetao Shenzhen Park. The administrative duties that will be undertaken by competent departments in Shenzhen include approvals for the purchase of narcotic drugs, psychotropic drug preparations, and standard and reference materials for teaching and research purposes; filings for internet information services for drugs and medical devices; issuance of free sales certificates for Category II and Category III medical devices; issuance of free sales certificates for drugs; filings for patent attorney practices; filings for branches of patent agencies; permits for auctioning business; and professional qualification certification for registered architects (for change of registration and deregistration of Class 1 registered architects only).

On 18 April, the National Medical Products Administration’s Center for Drug Evaluation issued an announcement on reporting and technical requirements for registration on the Mainland, under streamlined procedures, of Hong Kong and Macao-registered proprietary Chinese medicines for oral use. According to the announcement, which took immediate effect, documentation to be submitted by applicants include administrative documents, pharmaceutical information, documents supporting the marketing of the drug, inserts and packaging labels. Administrative documents include explanatory statements, application forms, materials for the approval of generic drug names, certification documents for medicine ingredients, pharmaceutical excipients and packaging materials, patent information and certificates, approvals for the marketing and sale of drugs, and the credentials of applicants/manufacturers in the Hong Kong and Macao Special Administrative Regions. Pharmaceutical information includes details of medicinal ingredients used, assessment of medicinal resources and techniques for the concoction and preparation of medicines, information on the quality of pharmaceutical preparations, and details on packaging, storage and the validity period of the drugs concerned.

Mexico has updated its mandatory standard on good manufacturing practices for medical devices, with the new requirements effective from 30 November.