Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

When Medical Device Software Changes Warrant a new FDA 510(k)

US medical device market regulators have clarified their recommendations for when changes to software or firmware should prompt a manufacturer to file a new 510(k) premarket notification for a medical device.

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Brazilian Regulators Set Date for More Flexible Medical Device Registration Transfer Rules

Brazil’s medical device market regulator ANVISA will implement new rules for more efficient transfers of device registrations between Brazilian Registration Holders (BRH).

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Japanese MHLW Takes Steps Toward Aligning ISO 13485:2016 with Its Own QMS Requirements

Japan’s Ministry of Health, Labour and Welfare (MHLW) has published an administrative notice on how some of the new ISO 13485:2016 quality system standard for medical devices will be incorporated into the country’s own QMS requirements.

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South African Medical Device Regulatory System Set for Implementation

The South African government has set an August 2016 implementation date for registration of medical device manufacturers, importers and distributors first proposed in late 2015.

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ANVISA Adds LNE G-Med to List of MDSAP Auditors

Brazilian medical device market regulators have recognized Laboratoire National de Métrologie et d’Essais’s G-MED Certification Division (LNE G-Med) as an accredited auditor under the Medical Device Single Audit Program (MDSAP).

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US FDA Reduces Medical Device 510(k) Registration Fees 10% for 2017

The US Food and Drug Administration’s medical device registration user fees for the agency’s 2017 fiscal year have decreased nearly across the board, including 10% reductions for 510(k) premarket notifications.

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Malaysia Update: Labeling, Exemptions, Advertising Rules

Medical device market regulators in Malaysia have recently issued new and updated rules regarding the planned transition to new labeling requirements, as well as clinical research exemptions and advertising rules for devices.

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Updated FDA Recommendations for When Medical Device Changes Require New 510(k)s

US medical device regulators have issued new recommendations for determining when changes to a registered medical device require filing a new 510(k) application.

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ANVISA Officially Extends Deadline for IVD and Cadastro Technical Dossier Requirement

Brazil’s medical device regulator ANVISA has announced official extensions for deadlines to file technical dossiers for low-risk cadastro medical devices as well as IVDs.

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UDI Guidance: Five Key Steps to FDA Unique Device Identifier Compliance

New guidance from the US Food and Drug Administration lays out key components of Unique Device Identifier (UDI) form and content that medical device manufacturers should incorporate into their compliance efforts.

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