ARQon Product Registration in Medtech

Product Registration can be complicated depending on each country's requirements and classification, but ARQon can register and be an in-country representative for your product.

ARQon provides regulatory service and guidance to overseas and local manufacturers who are interested in supplying or trading their medical device in targeted countries. The support can be from pre-market to post-market as shown below: 

• Obtaining approval for Product Registration for Medical Devices and/or Drug-device products by submitting a good dossier with proper planning for CE marked in EU, US, Asia including ASEAN and global;
• In-Country product license holder
•  Post-market vigilance reporting with the understanding of local reporting and handling requirements for those countries;
•  Establishment registration; and
•  Other authorization and market access.