REGISTRATION FOR MEDICAL DEVICE
 

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 checklist submission requirement for Medical Device Registration can vary depending on each country's requirements and classification, but we can register and be an in-country representative for your product. 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.

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