Regulatory Updates

Singapore HSA releases draft guidance on medical device UDI system

Sep 27, 2022

Singapore’s HSA to Commence Phase I Implementation of UDI Labeling in November 2022

Singapore’s HSA begins implementing Phase I of its UDI system requirements.

Brazil ANVISA provides new details on proposed UDI framework for medical devices

Sep 16, 2022

Brazil ANVISA Announces Major Medical Device Registration Updates

Updates include changes to ANVISA classification rules for software as a medical device (SaMD), technical dossier rules and more

Sep 16, 2022

New European Guidelines on Notified Body Surveillance Obligations Under the IVDR

The European Commission’s Medical Device Coordination Group (MDCG) has published guidance covering surveillance activities required of Notified Bodies under Article 110 of the In Vitro Diagnostic Medical Devices Regulation (IVDR).

US FDA formally proposes aligning Quality System Regulations with ISO 13485

Sep 15, 2022

New US FDA Guidance Covers Computer Software Assurance for Medical Device Production

The US Food and Drug Administration has published new guidance recommending appropriate risk-based computer software assurance processes related to medical device production and quality systems in order to raise device manufacturing quality levels.

US FDA medical device user fees see modest increase for 2022

Sep 12, 2022

US FDA Sets Emergency Use Authorization Policy for Monkeypox Diagnostic Test

New guidance from the US Food and Drug Administration establishes emergency market access for in vitro diagnostic (IVD) tests to diagnose monkeypox infections.

Sep 11, 2022

New European Manual on Borderline and Classification for Medical Devices and IVDs Issued

European Commissioners have published a highly anticipated new version of the Manual on Borderline and Classification for medical devices under the Medical Devices Regulation (MDR) and for in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Med

Sep 6, 2022

Australia Update: Medical Device UDI Implementation, Essential Principles Guidelines

The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance requirements and guidelines for active med

Aug 30, 2022

European MDCG Issues Recommendations to Strengthen Notified Body Capacity

New European MDCG paper lays out actions to increase Notified Body capacity, avoid medical device and IVD shortages

Aug 28, 2022

Indian Regulators Add to List of Medical Device Testing Laboratories

India CDSCO adds three more organizations to list of Medical Device Testing Laboratories( MDTLs)

South Korea MFDS plans several medical device regulatory updates for 2022

Aug 28, 2022

South Korea Updates: Innovative Device Designations, IVD Act Enforcement

Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for manufacturers.

Aug 24, 2022

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.

Aug 15, 2022

US FDA Rolls Out Final Guidance on Unique Device Identifier (UDI) Labeling Requirements

Final FDA guidance on Unique Device Identifier (UDI) rules for medical devices and stand-alone software comes several years after draft guidance issued. Learn more at Emergo by UL.

Mar 18, 2022

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.

Mar 13, 2022

US FDA Recommendations for Voluntary Recalls of Medical Devices and Products

Final guidance from US FDA covers how manufacturers and distributors should develop and initiate voluntary recalls of products including medical devices, IVDs and pharmaceuticals. Learn more at Emergo by UL.

US FDA rolls out notification requirements to protect medical device supply chains

Mar 10, 2022

US FDA Issues Quality Management System Amendment FAQs

US FDA has provided answers to Frequently Asked Questions regarding planned harmonization of 21 CFR Part 820 quality management system requirements with the ISO 13485 standard.

Mar 6, 2022

How Long is the FDA Review Process for 510(k) Medical Device Submissions?

US FDA provides communication timeline for 510(k) reviews in accordance with MDUFA III performance goals.

Proposed US FDA program targets medical device supply chain shortages

Mar 5, 2022

Options for Medical Device Companies to Appeal US FDA Regulatory Reviews and Decisions

FDA guidance outlines appeal options for medical device industry stakeholders disputing regulatory decisions and actions by the Center for Devices and Radiological Health (CDRH). Learn more at Emergo by UL.

Feb 25, 2022

US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

Proposed rule from US Food and Drug Administration harmonizes 21 CF Part 820 to ISO 13485 quality management system standard for medical devices.

Feb 23, 2022

US FDA Rolls Out Notification Requirements to Protect Medical Device Supply Chains

New US FDA guidance on notifications of medical device discontinuation or supply disruption during public health emergencies.

Feb 11, 2022

New Guidelines from Japanese Regulators Cover Medical Device Cybersecurity, Remanufactured Devices and MDSAP Reports

Latest guidelines from Japan MHLW and PMDA address medical device cybersecurity, remanufactured devices and MDSAP applications. Learn more at Emergo by UL.