The Singapore HSA–UK Fast Track Pathway 2025 introduces a Regulatory Innovation Corridor between Singapore’s HSA and the UK’s MHRA. The initiative allows companies to seek joint regulatory advice, accelerating access to breakthrough therapies in areas such as cancer, rare diseases, gene therapy, and digital health. The pathway improves regulatory efficiency while maintaining safety and strengthens both countries’ roles as global life sciences hubs.

The EU Commission’s 2025 Economic Operator Survey examines medical device availability under MDR/IVDR using data from manufacturers, authorised representatives, importers, and distributors. It highlights certification delays, documentation challenges, and discontinuation of niche devices. The findings show increasing risks to EU supply continuity, emphasizing the need for early planning, complete technical documentation, and close collaboration with notified bodies.

Malaysia’s Medical Device Import Permit enforcement, initially set for 2 January 2026, has been postponed to 1 July 2027. Until then, importers follow existing customs procedures. From 1 June 2026, stakeholders may voluntarily submit Verification Slips for non-medical devices under medical device tariff codes via the ePermit system. Local distributors are advised to review portfolios, update SOPs, and monitor the MDA portal for the latest guidance to ensure a smooth transition.

The EU EUDAMED mandatory modules 2026 requirement comes from Decision (EU) 2025/2371, which confirms four modules—Actor Registration, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance—are fully functional. From 28 May 2026, manufacturers must register new MDR/IVDR devices before placing them on the EU market, while legacy devices must be registered by 28 November 2026. Certificates issued before that date must be uploaded by 28 May 2027.

The swissdamed UDI Playground, launched in November 2025, gives economic operators a free testing environment to practise UDI XML uploads and data validation before the swissdamed UDI Devices module becomes mandatory. Registered companies can test versioning, onboarding, and UDI registration workflows. Swissmedic also provides a 13-page guide explaining access, actor registration, XML upload steps, and validation rules.

Anvisa’s 2025 Modernization Plan reduces the medical device post-registration backlog by 40%, shortens review times for biological products and clinical research, and clears radiopharmaceutical pipelines. The agency is investing 25 million reais in AI and hiring 102 new specialists, marking its largest team expansion since 2014. Queues are expected to be cut in half within six months, with full normalization within a year, improving efficiency, predictability, and regulatory support for medical device manufacturers in Brazil.

The EU MDR 2017/745 and IVDR 2017/746 pilot coordinated assessment lets sponsors submit one application for multinational clinical investigations and performance studies. The system streamlines approvals, reduces duplicative national submissions, and prepares Member States for mandatory coordinated assessment. Eligibility includes Class III and certain Class II devices, as well as IVD performance studies under Article 58. Sponsors must confirm intended use, documentation, and risk class before applying.

The FDA Pre-RFD Guidance 2025 updates the 2018 version for combination product sponsors seeking preliminary, non-binding feedback. The guidance explains how to submit a Pre-Request for Designation, clarifying regulatory classification, responsible FDA centers (CDER, CBER, or CDRH), and meeting elements including materials, request format, and timelines. Early interaction supports planning, confirms regulatory assignment, and helps mitigate risks in development and marketing applications for drugs, devices, biologics, or combination products.

ISO 10993-1:2025 (Edition 6) revises the biological evaluation of medical devices, replacing Table A1 with a risk-based, lifecycle approach aligned with ISO 14971. Manufacturers must now focus on identifying actual biological hazards, exposure duration, and material characteristics, providing scientific justification for all tests. The update emphasizes safety throughout the device lifecycle rather than minimum required tests, shaping a more flexible, scientifically grounded approach for compliance and regulatory submissions.