Medical Device Registration – Brazil ANVISA
In this complimentary webinar, we examine current medical device registration requirements in Brazil, recent regulatory changes and current ANVISA registration requirements.
Japan PMD Act Revisions Include Fast-track Reviews for Some Medical Devices and IVDs
Fast-track Japan PMDA registration now open for qualifying medical device and IVD manufacturers as PMD Act revisions begin taking effect.
An Assessment of the Proposed Rule to Change US FDA’s Interpretation of Intended Use
Analysis of FDA's proposed new definition of Intended Use concepts pertaining to medical devices and drugs, and recommendations for how manufacturers can prepare for possible changes.
Defining Critical Tasks for Human Factors Validation Tests of Combination Products
FDA Center for Drug Evaluation and Research (CDER) has different expectations regarding HF validation testing of combination products than the agency's Center for Devices and Radiological Health (CDRH).
TFDA Releases Details About Transition to New Taiwanese Medical Device Regulations
The Taiwan Food and Drug Administration (TFDA) has published documents explaining aspects of the transition to new medical device regulations.
Singapore HSA Releases Draft Guidance on Medical Device UDI System
Singapore's Health Sciences Authority (HSA) published a draft guidance providing a comprehensive view of the upcoming Unique Device Identifier (UDI) system for medical device manufacturers and importers.
TFDA Makes Further Announcements Regarding New Medical Device Regulations and Fees
Emergo by UL has assembled this roundup of key communications dealing with a new listing process for designated Class I devices.
US FDA Aims to Improve Cybersecurity Related to Servicing and Maintenance of Medical Devices
FDA seeks feedback from stakeholders on four key cybersecurity issues associated with servicing of medical devices. Learn more about US FDA medical device cybersecurity regulations at Emergo by UL.
Electronic Medical Records Design: Five Things I Love About You
Recommendations for designing user-friendly electronic medical records for use by healthcare providers and clinicians.
US FDA Cybersecurity Alert: Risks Found in Medical Device Software Components
The FDA reports cybersecurity threats found in some software components require medical device makers to take prompt action.