Product Registration (Registration)

Traders: (Product Registration Asia, CE, US)

ARQon provide services to Overseas or Local manufacturer or Distributor who are interested to supply/trade their medical device in the targeted countries with ARQon regulatory support in all the company regulatory matter in the countries or region from Pre-market to Post-market for example:

• Product Registration for Medical Device and Drug-device combination product to obtain product approval with proper planning for a good dossier for submission for CE mark, US, Asia, ASEAN and global countries approval.
• Post-market vigilance reporting with understanding of local reporting and handling requirements for those countries
• Establishment registration
• Other authorization and market access