Mexico’s General Health Law reform, published on 15 January 2026, updates Article 376 to allow medical device sanitary registration renewals for up to 10 years. Initial registrations remain valid for five years, but timely renewal requests and strict compliance are required to avoid cancellation by COFEPRIS. The change impacts long-term regulatory planning for medical device manufacturers in Mexico.

The Malaysia-Thailand Medical Device Regulatory Reliance Pilot 2026 enables faster approvals for class B/C/D devices by leveraging mutual regulatory assessments. Manufacturers with devices registered in either country can benefit from shorter review timelines, waived fees, and reduced duplication. The 3-month pilot (1 Feb–30 Apr 2026) supports faster patient access to safe, innovative medical devices and may serve as a model for future ASEAN regulatory reliance initiatives.

Pure Global has launched a flat-fee pricing model for medical device registration that simplifies global expansion across 13 key markets. With AI-assisted dossier preparation and in-country representation included, manufacturers can easily plan their market access budgets.

Thailand’s 2025 Medical Device Labeling Regulation (B.E. 2568) sets requirements for labels and documentation of home-use, professional-use, software, reusable instruments, and accessories. Labels must include product name, intended use, batch/lot number, manufacturing/expiry dates, and manufacturer/importer info in Thai or English. Electronic documentation is allowed for software devices. Compliance is mandatory by June 20, 2026, with post-import labeling completion within 120 days.

The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed interpretations of MDR and IVDR PMS requirements and explains how to integrate PMS into the Quality Management System (QMS). This practical guidance helps manufacturers proactively monitor device safety and performance throughout the device lifecycle, creating stronger and more compliant PMS systems.

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 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.

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 Brazil Anvisa Regulatory Agenda 2026–2027 sets out 161 priority topics that Anvisa plans to regulate or review over the next two years. Developed through public consultation and technical review, the agenda improves transparency and predictability across medicines, medical devices, food, cosmetics, and health services. It helps companies anticipate regulatory changes and plan compliance strategies more effectively.