UK Update: MHRA Opens Consultation on Update to Statutory Fees
The UK MHRA has released details of a consultation to provide ongoing cost recovery.
EU Update: Current State of Medical Device Regulations
Returning from a long holiday and need to catch up on EU medical device and IVD regulatory developments? Read our update on European regulatory news over the last few months.
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.
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.
Hong Kong Database Update: Electronic Adverse Event and Safety Report Features
The Hong Kong Department of Health has delayed release timelines for multiple new Medical Device Information System (MDIS) features to September 2024, including electronic submissions for adverse event and safety alert reports.
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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.