Regulatory approval isnβt optional β and having a qualified local representative is essential for market access and ongoing compliance.
At CMS SciDoc, we specialize in providing Professional Local Representation Services to ensure smooth regulatory compliance and successful product registration in both markets:
π π¦πΊ Australia β TGA Compliance
Official Australian Sponsor β supporting submissions, ARTG inclusion, and communication with the Therapeutic Goods Administration.
π π³πΏ New Zealand β Medsafe Compliance
Authorized NZ Agent β managing regulatory liaison and maintaining your ongoing obligations with Medsafe.
Our end-to-end services include:
β Regulatory submissions & ARTG inclusion
β Post-market surveillance & adverse event reporting
β Direct liaison with TGA & Medsafe
β Support for Class IβIII and IV medical devices
π Stay compliant
π Accelerate market entry
Contact us today to discuss your regulatory strategy or book a confidential consultation: info@cmsscidoc.com
Medical Device Manufacturers β Expanding into Australia or New Zealand?