Connect and stay on top of the MedTech regulatory landscape globally.

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.

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.

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.

Pure Global's new CTO, Ran Chen, brings over a decade of experience in building and scaling machine learning products.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.

Unlock efficient market access with Pure Global & MEDIcept's collaboration. From registration to regulatory expertise, we offer comprehensive solutions worldwide. Drive growth & innovation in MedTech.

Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.