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The European Commission updated its consolidated list of links to Notified Body standard-fee schedules on 13 July 2026. The list helps medical device and IVD manufacturers access published certification fee information for budgeting and Notified Body selection.

MDCG 2026-5 confirms that UDI-DIs must remain linked to the manufacturer in private-label and distributor-brand arrangements. Manufacturers retain legal responsibility for UDI assignment, maintenance, and EUDAMED registration, even when practical activities are delegated.

The World Health Organization recognized Brazil’s ANVISA as a Transitional WHO Listed Authority for Medical Devices (tWLAs-MD) on 1 July 2026, acknowledging its regulatory oversight of medical devices and IVDs. The designation supports WHO’s transition to the WHO Listed Authorities framework, promoting international regulatory reliance and confidence in ANVISA’s decisions.

The Malaysia Medical Device Authority (MDA) announced that Product Classification Applications will transition to a fully online submission process effective 1 August 2026. The new Product Classification Application System is intended to streamline classification requests, improve regulatory efficiency, and support Malaysia’s digital transformation of medical device regulatory services.

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.