What's Changed? In July 2026, France's National Agency for the Safety of Medicines and Health Products (ANSM) reinforced its expectations regarding medical device vigilance and post-market surveillance, publishing updated guidance to help manufacturers, importers, and economic operators comply with the European Union Medical Device Regulation (EU MDR). The updated guidance highlights manufacturers' responsibilities for reporting serious incidents, monitoring device performanc

What's Changed? In May 2026, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) published the draft Medical Devices (Amendment) Regulations 2026, marking one of the most significant proposed reforms to Great Britain's medical device regulatory framework since Brexit. The draft regulations introduce updated pre-market requirements for medical devices and in vitro diagnostic (IVD) devices, with proposals designed to strengthen patient safety while improving acc

What's Changed? On 1 July 2026, Australia's Therapeutic Goods Administration (TGA) commenced the mandatory implementation of Unique Device Identification (UDI) requirements for higher-risk medical devices, beginning with Class IIb and Class III devices. The new requirements are designed to improve the identification and traceability of medical devices throughout their lifecycle, supporting stronger post-market surveillance, faster safety actions, and greater transparency acro

What's Changed? On 17 June 2026, Health Canada announced Phase 2 of its Medical Device Establishment Licence (MDEL) modernisation, introducing updated regulations and revised guidance aimed at strengthening Canada's medical device regulatory framework. The amendments, which will take effect on 14 December 2026, are intended to reduce unnecessary regulatory burden while improving regulatory clarity, transparency, and oversight. Among the key changes are revised licensing requi

What's Changed? On 19 May 2026, Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published the final version of NOM-137-SSA1-2025, the country's updated labelling standard for medical devices. The new standard introduces important revisions to labelling and Instructions for Use (IFU) requirements, updates key regulatory definitions, clarifies manufacturer responsibilities, and aligns several provisions more closely with internationally recognis

What's Changed? On 12 June 2026, Brazil's National Health Surveillance Agency (ANVISA) announced additional support measures as the country transitions to the Declaração Única de Importação (DUIMP), Brazil's new Single Import Declaration system. Since 27 April 2026, DUIMP has become mandatory for many import operations requiring ANVISA authorisation, replacing the previous Import Licence (LI) and Import Declaration (DI) processes. The new model centralises customs, fiscal, co

Regulatory Update The Philippine Food and Drug Administration (FDA) continues advancing its digital transformation agenda through the expansion of its FDA eServices Portal, reinforcing its commitment to improving the efficiency, accessibility, and transparency of regulatory services. By encouraging regulated companies to submit applications and manage regulatory transactions through digital platforms, the FDA aims to streamline interactions with industry while supporting a mo

Regulatory Update Vietnam continues to refine its medical device regulatory framework as the Ministry of Health implements measures aimed at supporting market continuity while strengthening regulatory oversight. Recent regulatory developments have focused on extending the validity of certain medical device registrations and import authorisations, providing manufacturers and healthcare providers with greater regulatory certainty during the country's ongoing regulatory transiti

Regulatory Update Malaysia's Medical Device Authority (MDA) has strengthened its collaboration with Lazada Malaysia to enhance oversight of medical devices sold through online marketplaces. The initiative aims to improve the monitoring and enforcement of medical device regulations in the digital marketplace by strengthening controls over product listings, advertising, and seller compliance. Through this partnership, non-compliant medical device listings can be identified and

Regulatory Update China remains one of the world's most attractive healthcare markets, but market access comes with significant regulatory investment. In June 2026, industry analysis highlighted the latest National Medical Products Administration (NMPA) registration fee catalogue for drugs and medical devices, providing updated insights into the official administrative costs associated with registration, renewals, changes, and clinical trial applications. For many companies,

South Korea continues to strengthen its position as a global leader in digital health and artificial intelligence (AI)-enabled healthcare technologies. According to recent updates from the Ministry of Food and Drug Safety (MFDS), approvals, certifications, and notifications for AI-based Software as a Medical Device (SaMD) reached record levels in 2025, with further growth continuing into 2026. The trend reflects South Korea's ongoing efforts to support healthcare innovation t

Regulatory Update Indonesia's Halal Product Assurance Agency (BPJPH) has reaffirmed that cosmetic products circulating in Indonesia must obtain halal certification by 17 October 2026. The requirement is part of Indonesia's phased implementation of the Halal Product Assurance framework and applies to cosmetics, pharmaceuticals, chemical products, genetically engineered products, and certain consumer goods. For cosmetic manufacturers, importers, and brand owners, the deadline i