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

The US FDA updated Compliance Program CP 7382.850 on 2 February 2026, expanding inspections to a Total Product Life Cycle (TPLC) approach. The program aligns with QMSR (21 CFR 820) incorporating ISO 13485:2016 and emphasizes UDI, labeling, tracking, reporting, and postmarket surveillance. Manufacturers and importers must review quality systems, registration, and TPLC compliance to meet inspection and enforcement expectations.

The UK MHRA updated its medical device registration guidance on 16 January 2026, introducing new annual registration fees effective from 1 April 2026. Fees will be charged at approximately £300 per year per Level 2 GMDN® Category, replacing the current one-off fee model. Manufacturers must review GMDN® classifications, budget for recurring fees, and ensure all registrations and payments are managed through DORS.

Swissmedic published the results of its 2025 market surveillance focus campaign on medical device importers on 30 January 2026. Inspections of 30 importers and 232 devices identified deficiencies in 22% of devices, with higher non-compliance among legacy MDD devices than MDR devices. Key issues included importer labelling, product verification, and storage and transport conditions, highlighting the continued need for compliance improvements.

Commission Implementing Decision (EU) 2026/193 updates EU harmonised standards supporting the Medical Device Regulation (EU) 2017/745. Revised ISO standards now cover neurosurgical implants, biological and clinical evaluation, sterilisation, non-active surgical implants, breathing gas pathways, and small-bore connectors. Manufacturers should assess gaps, update technical documentation, and align conformity strategies to maintain MDR compliance.

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.