Why the IVDR preapplication process matters for legacy manufacturers

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.

ANVISA hosted a technical exchange with Chile’s ISP in July 2026 to strengthen medical device regulatory cooperation. The initiative covered Brazil’s regulatory framework, including registration, GMP certification, inspections, import controls, and post-market surveillance, supporting regulatory convergence and best practice sharing across Latin America.