Anvisa’s 2025 medical device certificate tool replaces Sicert, offering integration with Solicita, new templates, translations, and previews. Companies must transition before December 1, 2025, when Sicert stops issuing new certificates. Certificates can be validated via QR code or Anvisa’s consultation system. The modernized process improves efficiency, security, and international alignment while reducing regulatory risk for manufacturers, importers, and distributors in Brazil.

Anvisa’s 2025 reform introduces immediate and structural measures to reduce approval backlogs for medicines, medical devices, and clinical trials. The plan includes expanding staff, upgrading systems through AnvisAI, streamlining submissions, and deploying temporary task forces and risk-based inspections through 2026.

Colombia’s INVIMA 2026 UDI-DI requirement mandates that Class IIa medical devices registered before February 2024 incorporate UDI-DI coding. The final deadline is February 9, 2026. Manufacturers should review their portfolios, follow submission instructions, and complete registration early to avoid noncompliance, additional fees, or interrupted commercialization. Compliance ensures devices remain valid under current INVIMA regulations.

The updated Team NB guidance (29 October 2025, V2) clarifies IVDR Annex IX Section 5.2 for companion diagnostics (CDx). It outlines when changes to performance, suitability, or intended use require notified body approval through a new assessment or certificate supplement, with a flowchart to help manufacturers determine which changes are reportable.

Pure Global has launched AI Builder, a proprietary automation platform that cuts medical device dossier preparation time by up to 75%. The launch introduces a new flat annual pricing model and marks a major step toward on-demand, AI-powered global medical device registration.

ANVISA’s 2025 regulation reclassifies sodium-chloride saline solutions for nasal irrigation as Class IV medical devices under RDC 751/2022. Companies must complete transition their registrations from medicines to medical devices by May 30 2026. The rule clarifies transition conditions, GMP applicability, and stock-depletion policies, ensuring safer products and regulatory alignment with international standards.

Implementing Decision (EU) 2025/2078 updates harmonised standards for surgical drapes, gowns, clean air suits, medical face masks, and sterilizers under the EU MDR. The revised EN 13795, EN 14683, and EN 14180 standards ensure product safety, quality, and performance in line with the latest scientific developments. Manufacturers should update testing and documentation to maintain conformity and regulatory compliance.

Malaysia’s Medical Device (Amendment) Regulations 2025 [P.U.(A) 330] raise Class A medical device application fees from RM 100 to RM 500 and add a RM 750 registration fee effective 1 January 2026. Manufacturers must submit before 10 December 2025 to keep the current rate. The change supports MDA’s cost-recovery model and strengthens post-market surveillance in Malaysia’s device sector.

The UK MHRA’s 2026 DORS Fees Guidance introduces annual medical device registration fees based on GMDN Level 2 categories. Manufacturers must update and verify registrations before 30 March 2026 and pay fees via DORS within 90 days. The change replaces one-off charges with an annual, category-based model aligned with MHRA post-market surveillance.