Brazil's 2025 Contact US form provides foreign users with a dedicated channel to submit questions and access regulatory information directly. This digital modernization effort enhances accessibility, transparency, and international engagement while traditional channels remain available for Brazilian users. The initiative simplifies regulatory communication, supports stakeholder engagement, and demonstrates Anvisa’s commitment to evolving global digital standards.

In September 2025, the FDA finalized guidance on how it will authorize the emergency use of in vitro diagnostics (IVDs) during public health crises. Under FD&C Act section 564, the agency may permit unapproved IVDs when benefits outweigh risks, alternatives are limited, and risk controls are in place. The policy clarifies FDA’s enforcement discretion, aiming to balance timely patient care with safeguards against inaccurate results in emergencies.

The European Commission’s 2025 Guidance on Borderline and Classification of Medical Devices introduces key updates under MDR and IVDR, including reclassification of SARS-CoV-2 tests, new rules for electronic Instructions for Use (eIFU), and streamlined PAR forms. These changes reduce uncertainty for manufacturers, support digital compliance, and accelerate market access across the EU.

Swissmedic’s 2025 update to the Good Practices for Endoscope Reprocessing (GPAE) clarifies legal duties under the Swiss MedDO and aligns hygiene standards with the latest science. Prompted by compliance gaps revealed in hospital inspections, the guidance requires healthcare providers to update procedures, training, and documentation.

Australia’s TGA has released a 2025 compliance update clarifying how AI and software-based tools, such as digital scribes with diagnostic or treatment functions, may fall under medical device regulations. Developers must assess whether their products require inclusion in the ARTG and ensure compliance to avoid enforcement action.

Health Canada’s 2025 eSTAR pilot expands digital submission capabilities for Class III and IV medical devices, including IVDDs, through a guided, interactive PDF template. The initiative aims to streamline regulatory processes and test a new content conversion tool aligned with IMDRF standards. Up to 30 eligible participants will be selected to take part.

The Philippines FDA has extended its temporary suspension of 2025 medical device registration fees, granting manufacturers an additional 60 working days to register at legacy rates. This move, formalized under Department Circular No. 2025-0382, offers continued cost savings and a strategic window for market entry while the agency completes its review of the updated fee schedule.

The European Commission’s MDCG 2024-14 Rev.1, published in August 2025, extends the compliance deadline for applying Master UDI-DI to contact lenses until 9 November 2026. The revision also references new guidance, including MDCG 2025-7 and resources on highly individualised devices, giving manufacturers more clarity. With extra time to update labeling, documentation, and vigilance processes, companies should use this transition period to prepare for full MDR compliance.

Malaysia’s Medical Device Authority (MDA) has launched its first regulatory sandbox, creating a controlled environment for testing AI-driven medical technologies. The initiative lets developers validate innovations under real-world conditions while MDA monitors safety, compliance, and performance. By bridging regulatory oversight with innovation, the sandbox is designed to fast-track safe, patient-centric devices into Malaysia’s healthcare system.