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

The swissdamed UDI Playground, launched in November 2025, gives economic operators a free testing environment to practise UDI XML uploads and data validation before the swissdamed UDI Devices module becomes mandatory. Registered companies can test versioning, onboarding, and UDI registration workflows. Swissmedic also provides a 13-page guide explaining access, actor registration, XML upload steps, and validation rules.

The EU EUDAMED mandatory modules 2026 requirement comes from Decision (EU) 2025/2371, which confirms four modules—Actor Registration, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance—are fully functional. From 28 May 2026, manufacturers must register new MDR/IVDR devices before placing them on the EU market, while legacy devices must be registered by 28 November 2026. Certificates issued before that date must be uploaded by 28 May 2027.

Anvisa’s 2025 Modernization Plan reduces the medical device post-registration backlog by 40%, shortens review times for biological products and clinical research, and clears radiopharmaceutical pipelines. The agency is investing 25 million reais in AI and hiring 102 new specialists, marking its largest team expansion since 2014. Queues are expected to be cut in half within six months, with full normalization within a year, improving efficiency, predictability, and regulatory support for medical device manufacturers in Brazil.

The FDA Pre-RFD Guidance 2025 updates the 2018 version for combination product sponsors seeking preliminary, non-binding feedback. The guidance explains how to submit a Pre-Request for Designation, clarifying regulatory classification, responsible FDA centers (CDER, CBER, or CDRH), and meeting elements including materials, request format, and timelines. Early interaction supports planning, confirms regulatory assignment, and helps mitigate risks in development and marketing applications for drugs, devices, biologics, or combination products.

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.

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.