On 20 June 2025, the European Commission (“Commission”) announced that it has decided to exclude Chinese companies from EU government purchases of medical devices exceeding €5 million. This measure follows the conclusions of the first investigation under the EU’s International Procurement Instrument.

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 2 June 2025, the majority of EU Member State governments are reported to have approved a proposal to limit the access of Chinese companies to the European public procurement market. Pending the confirmation of the European Commission (Commission), the proposal aims to restrict access of Chinese medical device makers to any EU public procurement contract worth more than €5 million for the next five years. According to the Commission, this action is taken in response to the actions of the government of the Chinese mainland and seeks to level the playing field for domestic companies, which reportedly face restrictions when entering the market of the Chinese mainland.

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).