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

The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonized standards across several medical device areas. Manufacturers should review technical documentation, declarations, test documentation, and internal standards registers against the revised list.

MDCG 2021-5 Rev.1 clarifies the transition from EC REP to EU REP after EN ISO 15223-1:2021/A1:2025. Manufacturers may use EC REP, EU REP, or both symbols during a 60-month transition ending on 17 June 2031, provided Authorized Representative information remains clear and intelligible.

Malaysia's Medical Device Authority (MDA) and Japan's Ministry of Health, Labour and Welfare (MHLW) have signed a Memorandum of Cooperation (MoC) in Tokyo, marking a significant step toward regulatory alignment and closer collaboration between the two countries. The agreement lays the groundwork for more efficient medical device registration, enhanced information sharing, and improved post-market surveillance frameworks. Manufacturers operating in both markets could benefit from greater regulatory predictability and streamlined market access as the partnership develops.

The U.S. FDA human factors guidance 2026 update revises requirements for human factors information in medical device marketing submissions, including 510(k), De Novo, and PMA pathways. It introduces new risk-based Human Factors Submission Categories 1–3, expands examples for modified devices, and clarifies expectations for usability validation. Sponsors must assess use-related risks, device complexity, and interface changes when determining submission requirements to ensure compliance with FDA usability engineering expectations.

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.