Jun 23, 2022

Saudi FDA postpones Unique Device Identification compliance deadlines

The UDI compliance date depends upon risk class of the medical device

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Jun 23, 2022

US FDA finalizes guidance on machine learning for medical devices

The agency outlined the information required in premarket submissions
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Jun 20, 2022

Wiklund's Perspective: IFU designers--helping us get through the pandemic

The key role IFU play in the safety and effectiveness of at-home medical tests and technologies
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Jun 17, 2022

MDR watch: European regulators urge greater compliance efforts to avoid medical device shortages

European MDCG downplays Article 59 as viable MDR transition compliance option
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Jun 16, 2022

South Korea updates regulations on medical device codes and classification

MDFS issues updates to medical device and IVD regulations
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Jun 16, 2022

Japan’s medical device regulators update PMD Act and the online submissions process

Manufacturers must now comply with updated procedures
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Jun 13, 2022

China market update: Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific guidelines and technical review points

Chinese medical device market regulators provide clarity on new rules
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Jun 9, 2022

US FDA withdraws COVID-era guidance for medical device and IVD market approval processes

Medical device manufacturers must prepare for full FDA registration process
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Jun 8, 2022

New Swiss IVD regulations come into force as EU mutual recognition agreement expires

New Swiss IvDO shares many requirements with European IVDR
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Jun 7, 2022

India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses

Licensees must comply with Medical Devices (Third Amendment) Rules, 2022
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Jun 2, 2022

Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials

Certain medical tests used in clinical trials must comply with the IVDR.
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Jun 1, 2022

Australia Market Update: TGA defines which digital mental health software it regulates

Digital mental health tools may be regulated as medical devices.
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May 31, 2022

Considerations for post-HF validation design changes

An HFR&D framework for managing medical device design changes
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May 27, 2022

ANVISA extends Brazilian Good Manufacturing Practice requirements to more medical device manufacturers

More medical device and SaMD manufacturing units now subject to BGMP certification rules
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May 25, 2022

IVDR watch: New guidance from European MDCG ahead of date of application

Four new guidance documents from European regulators as IVDR comes into effect
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May 24, 2022

IVDR Watch: European regulators add ISO 14971 to harmonized standards list

Risk management standard EN ISO 14791:2019 added to IVDR reference list.
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