Medical Regulations Gate – MRG

Medical Regulations Gate-MRG is a consultancy company based in the Middle East that provides our clients with the Regulatory support needed for Medical Devices to ensure easier access to the Middle East Region.

Since 2012, we have worked with over 300 Medical Devices Manufacturers and have helped them regulate their Medical Devices efficiently. We believe that we can offer your company the same quality of services and below are some key points to consider:

• In Saudi Arabia, the regulatory changes being implemented are vastly affecting the market for medical devices. Recently, Saudi Food and Drug Authority (SFDA) has published a new announcement where medical device manufacturers must submit the full Technical File dossier to SFDA rather than just submitting a few regulatory documents to obtain approval to market the device in Saudi Arabia.

As a result, many manufacturers identified the risks involved with sharing these documents with their local distributor specially if they do not have the regulatory team capable of managing such a high volume of documents or might face the risk of your confidential information falling in the wrong hands.

• In Egypt, we strongly believe that manufacturers should have more control over their medical devices in the Market and that is part of the unique concept that MRG offers to its clients where they have the freedom to deal with more than one distributor in the market while also gaining the optimum regulatory support for their medical devices.

Medical regulatory gate-MRG has a specialized team that will handle your documents with a high level of competency, avoiding the burden of registering and licensing.

Company’s Keywords:

authorized representative outsourcing, medical device consultancy services, medical device regulation approval services, regulatory affairs service provider