MtechGroup

Frequently Asked Questions about the New Device Registration and Listing Requirements

(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm?source=govdelivery)

This list of FAQs is being provided to assist medical device establishments with understanding the new requirements and responsibilities for registration and listing that will become effective October 1, 2012.

Frequently Asked Questions about the New Device Registration and Listing Requirements

We assist the FDA in communications with the foreign establishment
responding to the questions concerning the foreign establishment's devices that are imported into the US.
We prepare all medical device approval documents, such as 510K application, and submit the documents to an appropriate regulatory agency such as FDA and HC on behalf of our clients.

Mtech Group keeps up and stays current with the latest dental and medical device technologies to provide the most effective medical device regulatory related consultation to our clients who wish to enter the North American market!!!