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European IVD Regulatory Approval Process

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

European In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process

This process chart illustrates the CE marking certification process per device classification and is available for download in the Regulatory Affairs Management Suite (RAMS).

US FDA Registration Process for Medical and IVD Devices

This process chart illustrates the FDA approval process per device classification in the U.S. and is available for download in the Regulatory Affairs Management Suite (RAMS).

Japanese Regulatory Approval Process for Medical Devices

This process chart illustrates the pathway to market per device classification in Japan and is available for download in the Regulatory Affairs Management Suite (RAMS).

Australian TGA Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the TGA approval process per device classification in Australia and is available for download in the Regulatory Affairs Management Suite (RAMS).

Chinese NMPA Regulatory Approval Process for Medical and IVD Devices

Our China regulatory process chart offers intuitive, high-level overviews of your paths to product registration.

What is a Clinical Evaluation Report (CER)?

This guide helps explain how to prepare a Clinical Evaluation Report for medical devices as well as what required updates need to be made.

European MDCG guidance identifies MDR compliance requirements for legacy devices based on task force report

European Medical Devices Regulation (MDR) CE Marking Regulatory Process

This process chart illustrates the CE marking certification process per device classification and is available for download in the Regulatory Affairs Management Suite (RAMS).

Saudi Arabian Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the SFDA approval process per device classification in the KSA and is available for download in the Regulatory Affairs Management Suite (RAMS).

Malaysian Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the MDA approval process per device classification in Malaysia and is available for download in the Regulatory Affairs Management Suite (RAMS).

Singaporean Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the HSA approval process per device classification in Singapore and is available for download in the Regulatory Affairs Management Suite (RAMS).

Europe CE Marking Regulatory Process for Medical Devices

This certification verifies that a device meets all regulatory requirements of the medical devices directive (MDD), In vitro diagnostic device directive (IVDD) or active implantable medical device directive (AIMD) as they apply to your product.

The New European Medical Devices Regulation (MDR 2017/745)

The first major revision to device regulations since 2007 has been released and the changes are significant. Smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute.

Costa Rica Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the MOH approval process per device classification in Costa Rica and is available for download in the Regulatory Affairs Management Suite (RAMS).

South Korean Regulatory Approval Process for Medical Devices

This process chart illustrates the MFDS approval process per device classification in South Korea and is available for download in the Regulatory Affairs Management Suite (RAMS).

Colombian Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the INVIMA approval process per device classification in Colombia and is available for download in the Regulatory Affairs Management Suite (RAMS).

Conducting a Medical Device PMCF Study

In this free webinar, you’ll gain insights from Emergo’s medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF study that should be acceptable to all stakeholders.

Hong Kong Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the MDD approval process per device classification in Hong Kong and is available for download in the Regulatory Affairs Management Suite (RAMS).

Mexican Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the COFEPRIS approval process per device classification in Mexico and is available for download in the Regulatory Affairs Management Suite (RAMS).

Marketing Medical Devices in the Post-Brexit Era: Working with a UK Responsible Person (UKRP)

The UK's withdrawal from the European Union has major ramifications for medical device manufacturers, including in-country representation requirements for companies selling their devices in Great Britain.

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