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Are you planning to expand your business into Malaysia?Are the numerous regulatory requirements leaving you confused?Which products must undergo CAB c…

ndatory Use of First Four EUDAMED Modules from 28 May 2026 To enhance transparency and safety in medical device regulation, the European Commission ha…

On February 3, 2026, the U.S. Food and Drug Administration (FDA) officially published the final guidance titled “Computer Software Assurance for Produ…

With the arrival of the new year comes new opportunities. GRZAN Group is ready to embark on its 2026 international journey—beginning in Dubai. The WHX…

Recently, Health Canada announced an update to the application and review fee structure for medical device licences.

Recently, the Vietnamese Ministry of Health (MOH) officially promulgated Circular No. 57/2025/TT-BYT.

Are aesthetic medical products regulated by ANMAT in Argentina?

The Directive has been formally gazetted, with mandatory enforcement commencing on 1 June 2026.

Key Compliance Considerations for Medical Device Registration in Kenya.

To continuously enhance the safety, quality, and performance of medical devices used in public healthcare institutions, the Hong Kong Department of He…

This article interprets the Manual for Registration of Health Products at ANVISA (Manual para Registro de Materiais de Uso em Saúde na ANVIS…

The European Commission has recently published its long-anticipated proposal to revise the Medical Device Regulation (MDR) and the In Vitro Diagnostic…