Emergo by UL Presents on European Regulation 2023/607 at KIMES 2024
To continue our KIMES 2024 medical device regulation coverage, we discuss our presentation on European Regulation 2023/607.
Emergo by UL Presents on the U.S. FDA eSTAR at Korea’s KIMES 2024
At Korea’s KIMES 2024 we revealed regulatory tips, including an overview of the current U.S. eSTAR template for submitting 510(k)s or De Novo reclassification applications to the U.S. FDA.
Australian TGA Updates Recall Reforms Program, Releases Version 2.4 of the URPTG
The Australian Therapeutic Goods Administration (TGA) communicated an update March 26, 2024 on its Recall Reforms Program for medical devices.
New Guidance on Clinical Investigation Plans for Medical Devices
The recitals of the Medical Devices Regulation (MDR) (EU) 2017/745 explain the importance of aligning clinical investigation provisions with ISO 14155.
WHO Announces Submissions Call for WHO Model List of Essential In Vitro Diagnostics
The World Health Organization announced a call for submissions (March 20, 2024) for its fifth Essential Devices List (EDL); an evidence-based health policy document analogous to the WHO Essential Medicines List.
Emergo by UL's Key Takeaways from the Finalized Version of China's NMPA HFE guidance
On March 19th, 2024, China’s National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) released a finalized version of its guidance about the application of human factors engineering (HFE) / usability engineering (UE) to medical device development. In this succinct article, we address the changes and updates from the prior draft guidelines for public comment, released in October 2023.
Pathway to MDSAP Whitepaper
Learn more about the steps in the MDSAP transition process.
Brazil Medical Device Regulator Delivers on Commitment to Publish Legislative Updates
As Brazil’s ANVISA RDC 848/2024 becomes mandatory in 180 days, medical device and IVD manufacturers must assess the additional compliance requirements and update their Essential Safety and Performance Requirement checklists.
Hospitalar 2024
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Extension of Brazil GMP Certificates to Four Years is Official
ANVISA extends validity of Brazilian Good Manufacturing Practice certificates from two to four years for medical device manufacturers participating in MDSAP