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New Brazil Regulation for Medical Devices Now In Effect – Steps to Take

Mar 9, 2023 | News

The new medical device regulation for Brazil, Regulation RDC No. 751/2022, issued on 21 September 2022, is now in force as of 01 March 2023. The Brazilian Health Regulatory Agency (ANVISA) updated the prior regulation (No. 185/2001) to provide for risk classification,...

Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

Jan 13, 2023 | News

Medical device reporting (MDR) is an important post-market activity that helps to ensure patient safety. The FDA receives over two million medical device reports annually, with malfunctions accounting for most reports received. The Voluntary Malfunction Summary...

European Union Clinical Trials Regulation: Mandatory Deadline Approaching

Dec 20, 2022 | News

Since 2004, clinical trials in the EU have been controlled by the European Union Clinical Trials Directive (EU-CTD). The directive was an attempt to standardize rules and enhance patient protections in clinical trials; however, its real-life implementation created...

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