Medical Device Product Registration

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: [email protected]. For assistance with policy or ...

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical …

5 Tips for Medical Device Registration across Global …

https://www.greenlight.guru/blog/medical-device-registration

Here are the two steps medical device establishments must follow, in the order listed, for product registrations and listings: Submit payment for an annual registration user fee, and. Complete the …

China registration update medical devices - elsmar.com

https://elsmar.com/elsmarqualityforum/threads/china-registration-update-medical-devices.86255/

Feb 9, 2023. #3. I apologise for the unclear message. Obviously the device is sold in China and is registered with NMPA as a medical device. Until now, the product …

Register medical devices to place on the market - GOV.UK

https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before they can be placed on the …

HSA | Medical device registration

https://www.hsa.gov.sg/medical-devices/registration

Medical device registration. You will need to register your medical device before supplying it in Singapore. Find out how to complete your product registration here. …