As announced by the National Medical Products Administration, the new edition of Good Manufacturing Practice for Medical Devices will enter into force on 1 November 2026. The revised edition consists of 15 chapters and 132 articles, and includes new chapters on quality assurance, validation and verification, and contract manufacturing and outsourcing.

The U.S. Drug Enforcement Administration recently adopted import and export restrictions on a central nervous system stimulant.

Health Canada is seeking public input through 17 January on a proposal to amend the Medical Devices Regulations (Establishment Licences) in an effort to modernise the regulatory framework for medical device establishment licensing while maintaining oversight of the supply of medical devices in Canada.

The United States has delayed implementing a 100% tariff on Singapore’s patent pharmaceutical exports as stakeholders negotiate exemptions. Initially scheduled to take effect on 1 October, the tariff applies to patented and branded pharmaceutical exports, unless Singapore-based companies set up production facilities in the US.