Sade Sobande
MEDICA 2024
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US FDA Announces De Novo Final Guidance and eSTAR Implementation Date
The FDA issued the Final Rule (FR Doc. 2024-18983) and Final Guidance on the Electronic Submission Template for De Novo (FDA-2023-D-3788) on August 23, 2024. Within the final guidance, the FDA announced that eSTAR would be compulsory for De Novos, beginning October 1, 2025.
Japan regulators MHLW/PMDA require compliance with HFE/UE standard
As of April 1, 2024, the Japanese regulatory authorities, the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Products Agency (PMDA) require compliance with JIS T 62366-1:2022, Japan’s national Human Factors Engineering (HFE)/Usability Engineering (UE) standard for medical devices.
Thailand FDA Makes Changes to Acceptable Documentation for Medical Device Registration
Thailand’s medical device regulator has released the list of regulators and agencies it will accept. The list includes the former Global Harmonization Task Force (GHTF) founding members the World Health Organization (WHO), and the Singapore Health Sciences Authority (HSA).
U.S. FDA Stage 1 Requirements for Laboratory Developed Tests
In its August 22 webinar, the U.S. Food and Drug Administration (FDA) discussed the Stage 1 requirements imposed on laboratory-developed test (LDT) manufacturers.
Frauke Schuurkamp
Open Forum: Human Factors Usability Testing Q&A
During this interactive session, our senior HFE experts answered pre-submitted and live questions about conducting usability testing of medical devices.
Complimentary Open Consultation Discussions
Meet with our experts to discover how we can support you in navigating complex medical device regulatory landscapes.
Introduction to South Korea’s Medical Device UDI System
This white paper discusses the basics of South Korea’s Unique Device Identifier (UDI) regulation and recommends steps for implementing a UDI system.