ANVISA 2025 Manual for Health-Use Materials Registration

On 16 December 2025, the EU published Proposal 2025/0404 (COD) to simplify MDR and IVDR requirements. Key measures include revised software classification rules, reduced re-certification obligations, expanded eIFU use, participation in MDSAP, increased flexibility for in-house devices, and new pathways for orphan and breakthrough innovations—aiming to reduce burden while maintaining patient safety.

The European Commission published a draft implementing regulation on 12 December 2025 to harmonize MDR/IVDR notified body practices. The proposal clarifies Annex VII requirements, including quotation information, conformity assessment timelines, and re-certification processes. Open for feedback until 23 January 2026, the initiative aims to improve consistency, transparency, and predictability across notified bodies operating under EU medical device regulations.

ANVISA’s 2025 manual for health-use materials registration standardizes requirements for medical device submissions in Brazil, aligned with RDC 751/2022. Manufacturers and importers can reduce errors, accelerate approvals, and improve application quality.

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.