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Get the latest global medical device regulatory news, insights from our experts, and more.

Oct 21, 2020

US FDA presents premarket submissions pilot program and patient-centered data resource pages

The Agency’s Center for Devices and Radiological Health (CDRH) will try using the Box filesharing service for submissions and is seeking to help manufacturers and stakeholders to incorporate Clinical Outcome Assessments and Patient Preference Information into their processes.

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Sep 22, 2020

Japan PMD Act revisions include fast-track reviews for some medical devices and IVDs

Phased updates to Japanese Pharmaceutical and Medical Products Act planned through 2022
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Sep 20, 2020

ANVISA eliminates Cadastro pathway for Class II medical devices

The Notificação pathway will now apply to both Class I and II medical devices and IVDs.
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Sep 16, 2020

Pre-Cert Update: US FDA lays out next steps for SaMD certification program

US FDA progress report on Pre-Cert registration program for Software as a Medical Device
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Sep 16, 2020

Russian Ministry of Health articulates role of SaMD in medical device regulation

The regulatory updates introducing a distinct category of software as a medical device are intended to harmonize Russian regulation with the IMDRF approach.
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Sep 15, 2020

US FDA updates final guidance on ISO 10993 for medical device biocompatibility

How conformity to ISO 10993 can help address FDA medical device biocompatibility requirements for US market access
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Sep 9, 2020

India’s CDSCO proposes extensive risk classification lists for medical devices and IVDs

CDSCO sets classification and registration pathways for hundreds of medical devices and IVDs
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Sep 8, 2020

In brief: Mexican Ministry of Health resumes normal operations

The announcement also details the extension of COFEPRIS deadlines for actions that were to have occurred during the more than five months of partial shutdown for COVID-19.
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Sep 4, 2020

Self-selection Studies: Guarding against contraindicated use of OTC medical products

Devising self-selection studies to help ensure that users do not buy the wrong product and use it in potentially harmful ways
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Sep 4, 2020

Medical device usability testing in China: Key considerations for manufacturers

Preview of new human factors usability testing guidance coming from Chinese medical device regulator NMPA
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Sep 3, 2020

UK MHRA issues new guidance on UK REP and medical device regulatory compliance

New guidance sheds more light on medical device regulatory compliance, UK REP role
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Sep 2, 2020

US FDA publishes FAQs on registering and importing devices during COVID-19

These documents also serve as helpful overview of FDA publications relating to the pandemic and Emergency Use Authorization (EUA) resources.
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Sep 1, 2020

Mexican medical device regulators move to electronic appointment system to reduce risk of coronavirus exposures

COFEPRIS electronic appointment system in effect as of September 1, 2020
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Aug 26, 2020

US FDA releases catalog of regulatory science tools

These tools are developed by the Office of Science and Engineering Labs to aid in the development of new medical devices.
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Aug 26, 2020

European MDCG sets deployment date for Eudamed actor registration module

December 2020 deadline for actor registration module of the Eudamed European medical device and IVD database
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Aug 25, 2020

US FDA identifies first two medical device types eligible for new streamlined 510(k) registration

Medical device regulators at the US Food and Drug Administration have issued final guidance for...
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