Imdrf.org

Software as a Medical Device

WEBSoftware for medical purposes continues to be increasingly important and influential in advancing public health. The Software as a Medical Device (SaMD) Working Group …

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URL: https://www.imdrf.org/working-groups/software-medical-device

Essential Principles of Safety and Performance of Medical Devices …

WEBTechnical document: IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)

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Essential Principles of Safety and Performance of Medical

WEBThis guidance document describes fundamental design and manufacturing requirements, referred to as ‘Essential Principles of Safety and Performance’ that, when met, provide …

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GHTF final documents

WEBGHTF final documents. These documents were created by the Global Harmonization Task force (GHTF). These are final documents and are still current. As the work of IMDRF …

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Artificial Intelligence/Machine Learning-enabled International

WEBArtificial Intelligence/Machine Learning-enabled (AI/ML) medical devices bring unique opportunities and regulatory considerations when advancing public health. The AI/ML …

Category: Medical Go Health

Principles of In Vitro Diagnostic (IVD) Medical Devices

WEBIMDRF/IVD WG/N64 FINAL: 2021 Page 7 of 16 21 January 2021 Control Material: substance, material or article intended by its manufacturer to be used to verify the …

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Medical Device Cybersecurity Guide International Medical Device

WEBMedical Device Cybersecurity Guide. As medical devices become more connected, there is the potential to impact patient safety. This is evident as cybersecurity …

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About IMDRF International Medical Device Regulators Forum

WEBAbout IMDRF. IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global …

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Adverse Event Reporting Guidance for the Medical Device

WEBGHTF SG2 N21 R8 May 1999 - The opinion, based on available information, from a healthcare professional; - Information concerning previous, similar events;

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Software as a Medical Device (SaMD): Key definitions

WEBThis document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses on a common definition for when software is considered to be a medical device …

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Regulatory Updates on Medical Devices in Republic of Korea

WEBGuidance on the subject of: Evaluation criteria for digital therapeutics for insomnia and alcohol/nicotine addiction. GMP operation of medical device software manufacturing …

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Principles of In Vitro Diagnostic (IVD) Medical Devices

WEBRule 3: IVD medical devices are classified as Class C if they are intended for use: in detecting the presence of, or exposure to, a sexually transmitted agent. Examples: …

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Note: This document was archived on June 21, 2005 from the …

WEB1 Design isinput the starting point requirements for product which design. form the The establish a basis for performing subsequent design development of a solid foundation of …

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MDSAP Assessment and Decision Process for the Recognition of …

WEBTechnical document: IMDRF/MDSAP WG/N11FINAL:2014

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IMDRF Strategic Plan 2021-2025

WEBNigeria - National Agency for Food and Drug Administration Control (NAFDAC) South Africa - South African Health Products Regulatory Authority …

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Terminologies for Categorized Adverse Event Reporting (AER): …

WEBTechnical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current release: IMDRF/AE WG/N43FINAL:2024 …

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UDI Guidance: Unique Device Identification (UDI) of Medical Devices

WEBTechnical document: IMDRF/UDI WG/N7FINAL:2013

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HSA'S REGULATORY JOURNEY & REGULATORY RELIANCE

WEBHSA adopted a reliance approach to leverage approvals granted by 5 reference regulatory agencies (from Australia, Canada, European Union, Japan and USA) Australia TGA …

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