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

Mexico has published NOM-137-SSA1-2025, a major overhaul of its medical device labeling standard that introduces stricter traceability requirements, expanded use of international symbols, and stronger sterility labeling expectations. Foreign manufacturers and importers will feel the greatest impact, with likely updates needed across labels, IFUs, and contra-labeling processes. With mandatory compliance kicking in on May 14, 2027, the roughly 360-day transition window makes now the right time to start your gap assessment.

The European Commission has published Regulation (EU) 2026/977, introducing standardized requirements for Notified Bodies that promise to bring much-needed consistency to EU MDR and IVDR conformity assessments. Manufacturers can expect clearer timelines, including a maximum of 90 days for technical documentation assessment and greater cost transparency in NB quotations. With the regulation applying from February 2027, now is the time to start preparing.

The European Commission has released the third 2026 update to the Manufacturer Incident Report (MIR) form version 7.3.1 (SB-11154), addressing technical bugs and compatibility issues affecting electronic vigilance submissions to EU and non-EU regulatory databases. While the changes may seem minor, manufacturers who don't update their workflows risk XML upload failures, rejected submissions, and potential audit nonconformities. Read on to learn what's changed and the concrete steps your regulatory team should take now to stay compliant.

Malaysia’s Medical Device Authority (MDA) has published the first edition of MDA/GD/0072 Change Management for Registered Medical Devices, which will replace MDA/GD/0020 following the official launch of MedCAST 3.0. Until implementation takes effect, the current change notification guidance remains applicable. Companies should review the new guidance and prepare for upcoming regulatory process changes.

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.