Gateway MedTech can support with: 
 

• Advise which markets to prioritize. It could be a good strategy to start and get established in a market, where product registration is easy or not required at all, pending the registration approval in a larger or more complex market; 

• Clarifying the correct classification for your medical device or IVD based on the local applicable regulatory system;

• Act as your Authorized Representative. Obtain the AR license and communicate on your behalf with the local authorities;

• Prepare and submit your application to have your medical device or IVD’s registered in the country of choice;

• Assure AR license or market authorization renewals or transfers are being dealt with;

• Support in the importation authorization documentation.

• Make sure that you comply with the local Post-Market Surveillance and/or Post-Market Vigilance & Materiovigilence requirements to maintain your right to do business within the country.