Medical Device Manufacturers – Expanding into Australia or New Zealand?

Regulatory approval isn’t 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:

πŸ’  πŸ‡¦πŸ‡Ί Australia – TGA Compliance
Official Australian Sponsor – supporting submissions, ARTG inclusion, and communication with the Therapeutic Goods Administration.

πŸ’ πŸ‡³πŸ‡Ώ New Zealand – Medsafe Compliance
Authorized NZ Agent – managing regulatory liaison and maintaining your ongoing obligations with Medsafe.

Our end-to-end services include:
βœ” Regulatory submissions & ARTG inclusion
βœ” Post-market surveillance & adverse event reporting
βœ” Direct liaison with TGA & Medsafe
βœ” Support for Class I–III and IV medical devices

πŸ”’ Stay compliant
πŸš€ Accelerate market entry

Contact us today to discuss your regulatory strategy or book a confidential consultation: info@cmsscidoc.com