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).
Singapore Medical Device Regulations
This chart illustrates the HSA medical device approval process in Singapore and is free to download in the Regulatory Affairs Management Suite (RAMS).
The New European Medical Devices Regulation (MDR 2017/745)
Watch this on-demand webinar to learn more about the European Medical Devices Regulation (MDR 2017/745), including how the MDR is organized, the scope of the legislation and device classification rules.
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 Korea MFDS Medical Device Regulations
Learn about South Korea's MFDS registration process per device classification, available for download in the Regulatory Affairs Management Suite (RAMS).