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

SWISSMEDIC SWISSDAMED registration 2026 mandates all IVDs, medical devices, and MD-DEVIT products be registered by 1 July 2026, with a transition period until 31 December 2026. Economic operators must ensure compliance, update QMS procedures, and coordinate registration with EU EUDAMED timelines. Accurate and timely registrations reduce risk of audits and inspections, ensuring devices are market-ready in Switzerland and aligned with EU regulations.

The EU Notified Bodies Survey 2026 shows MDR and IVDR certification trends, including application volumes, key compliance challenges, and Class C IVD deadlines. Manufacturers must address incomplete submissions, device misclassification, and other procedural issues to meet EU regulatory requirements. Planning early and engaging proactively with Notified Bodies is essential for timely market access.

COFEPRIS electronic notifications 2026 allow regulated entities in Mexico to receive official communications via email, covering updates on procedures, administrative requirements, and final resolutions. Businesses must complete the official authorization form and maintain accurate email addresses. The system improves communication speed, traceability, and legal certainty, reducing administrative backlog and enhancing compliance reliability for industries such as pharmaceuticals, medical devices, food, and cosmetics.

COFEPRIS modifications guideline 2026 defines procedures, documentation, and responsibilities for medical device registration changes in Mexico. It covers administrative and technical modifications, including manufacturer, distributor, and product name updates. All documents must be valid, in Spanish or English, and compliant with GMP, Free Sale, and Analysis certificate standards. Certain changes affecting safety or intended use require a new registration.

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.

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.