U.S. FDA Registration & Labeling Compliance Assistance

If you are manufacturer, exporter, re-packer of medical device and willing export to US market you need to get registered and receive FDA permission to have access to US market. Our medical device (class I and II) experts will provide you with guidance on required elements particularities of submissions that include

• We can determining what class of FDA Medical Device regulations will apply to your products
• Next step we will submit your registrations documents (along with trade names, official correspondent) with U.S. FDA in the specific category and assist you with your payment with U.S. FDA's requirements.

We will provide you with a Certificates of Registration to assure our customers that you have a valid U.S. FDA Registration.

In general, manufacturers introducing Class II medical devices to the US must submit a 510(k) to the FDA. A 510(k) is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect the device’s safety or effectiveness.

Obtaining a 510(k) is a process to clearing your medical device product in order to get FDA permission and hence access to market in the United States.

IF you are active medical device area you can ask for our expertise assistance in regards to specification, format and structure for a 510(k) submission. We can provide a the required assistance that includes:

• Verification of the specifications required elements of your 510(k) along with the labeling and related fee
• Assistance for the submission of your 510(k) to the U.S. FDA and payment