Process Charts

Vietnam Regulatory Approval Process for Medical and IVD Devices

This chart illustrates the DMEC approval process for medical devices in Vietnam and is available for download in the Regulatory Affairs Management Suite (RAMS®).

Thailand Regulatory Approval Process for Medical and IVD Devices

The Thai FDA medical device approval process explained: This process chart illustrates the approval process for medical devices in Thailand and is available for download in the Regulatory Affairs Management Suite (RAMS®).

Taiwan Medical Device Regulations

This chart shows Taiwan's medical device regulatory approval process and can be downloaded from the Regulatory Affairs Management Suite (RAMS) for free.

India Medical Device Regulations and Approval

This chart illustrates the CDSCO medical device approval process in India and is free to download in the Regulatory Affairs Management Suite (RAMS).

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

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

Comprehensive Guide to FDA Clearance for Your Medical and IVD Device

Learn how to get FDA clearance for your medical device and navigate the approval process smoothly with our 510(k) flowchart.

Japanese Regulatory Approval Process for Medical Devices

This process chart explains Japan's medical device registration pathway for approval as defined and explained by Japan Medical Device Nomenclature (JMDN).

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.

EU MDR CE Marking Certification Process

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

Saudi Arabia (SFDA) Medical Device Regulations

This chart shows the SFDA medical device approval process in Saudi Arabia and is free to download in the Regulatory Affairs Management Suite (RAMS).

Malaysian MDA Medical Device Regulations

This chart illustrates the MDA medical device approval process in Malaysia and is free to download in the Regulatory Affairs Management Suite (RAMS).

Process Charts

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS).
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Vietnam Regulatory Approval Process for Medical and IVD Devices