Medical Device Establishment Registration and Device Listing

When should I register my company?

The US FDA Establishment Registration & Medical Device Listing information must be submitted each year between October 1 and December 31, even if no changes have occurred. Listing information must be reviewed each year between October 1 and December 31, at the same time you review your registration information. If you have any update regarding your US FDA Establishment Registration & Medical Device Listing, you can submit it at that time.

Which is the cost for the annual registration user fee?

The US FDA Establishment Registration & Medical Device Listing user fee for fiscal year 2022 increased close to 2.30%. Please find below the 2021 and 2022 annual fee comparison:

Why FDA US FDA Establishment Registration & Medical Device Listing is really important?

US FDA Establishment Registration & Medical Device Listing provide the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

How can RQMIS help me?

Our US FDA Establishment Registration & Medical Device Listing services include:

• US Agent services for foreign companies
• FDA Medical Device classification
• Identification of initial importer requirements for the US and EU
• Operator number and establishment registration number
• US FDA Medical device and proprietary name listing
• Assistance for FDA’s registration fee payment
• National offices services (US)
• International offices services (UK and EU)