Product Registration (Registration)
Traders: (Product Registration Asia, CE, US)
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