If you want us to register / list your U.S. based company and
represent you to the CDRH - we do that.
Foreign manufacturers are required to also have a U. S. based "manufacturer's agent" as a regulatory representative to handle import issues. We also include in this fee - kind of an insurance policy so if a regulatory issue occurs in that year period- we take that task as part of the fee.
In our explanation, these new directives mean that the FDA will not communicate with you directly concerning any issues, the FDA would communicate with you - through us. They do not want to be concerned with overseas time zones and the inability to have any legal jurisdiction over you. Their jurisdiction would apply only to us. Refer to: 21 CFR 1005.25
CDRH Device Registration and Listing is tedious since the system applies to so many variations. If you sell a device covered by the CDRH it is likely you must register (electronically- only) your establishment and list your product. This is done yearly and there is a fee involved. The last time we downloaded the instructions for paying the annual fee it was almost 90 pages. This fee is to pay for the complexity of the system that was created.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration. Registration and listing provides 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. The registration fee & listing for fiscal years is $2,029.
ance/howtomarketyourdevice/registrationandlisting/
default.htm
Guidance/HowtoMarketYourDevice/RegistrationandListing/
ucm053165.htm
Foreign manufacturers are required to also have a U. S. based "manufacturer's agent" as a regulatory representative to handle import issues. We also include in this fee - kind of an insurance policy so if a regulatory issue occurs in that year period- we take that task as part of the fee.
In our explanation, these new directives mean that the FDA will not communicate with you directly concerning any issues, the FDA would communicate with you - through us. They do not want to be concerned with overseas time zones and the inability to have any legal jurisdiction over you. Their jurisdiction would apply only to us. Refer to: 21 CFR 1005.25
CDRH Device Registration and Listing is tedious since the system applies to so many variations. If you sell a device covered by the CDRH it is likely you must register (electronically- only) your establishment and list your product. This is done yearly and there is a fee involved. The last time we downloaded the instructions for paying the annual fee it was almost 90 pages. This fee is to pay for the complexity of the system that was created.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration. Registration and listing provides 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. The registration fee & listing for fiscal years is $2,029.
Device Registration and Listing
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/
default.htm
Who Must Register, List and Pay the Fee
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/
ucm053165.htm
