TGA Australian Medical Device Sponsorship / License Holding

As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia.

If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach.

About CMS:

CMS is a service provider for the following:

Cosmetics:

  • Cosmetics GMP ISO 22716 implementation and maintenance, including training
  • ISO 22716 1st /2nd Party Audits
  • Cosmetics Label review for Australian and International markets including Poisons/Schedule review
  • NICNAS Registration
  • AICS chemical substance database review
  • NICNAS Cosmetic Exemption (CE-1) and Secondary Notification
  • European/Global Production Information File (PIF) / Regulatory Dossier preparation and maintenance including safety assessment

Therapeutic Goods:

  • Australian TGA Sponsor for global Medical Device/Medicinal Product/IVD manufacturers
  • TGA Agent/Consultant for Australian Medical Device/Medicinal Product/IVD manufacturers and distributors
  • TGA GMP implementation and maintenance (Medicinal Products / API / Sunscreens), including training
  • TGA Therapeutic Goods Medical Device Regulations & ISO 13485 implementation and maintenance (Medical Devices including IVD’s), including training
  • Technical File/Product Dossier preparation and maintenance in compliance with Council Directives – 93/42/EEC Medical Devices
  • Technical File/Product Dossier preparation and maintenance in compliance with Council Directives – 98/79/EC in vitro diagnostics
  • Medical Device Testing to International/Harmonized Standards (Active/Non active)
  • 1st /2nd Party Audits
  • Risk Management ISO 14971 | ICH Q9

Miscellaneous:

  • Integrated Management Systems implementation and maintenance (ISO 9001 / OH&S / ENV), including training
  • Implementation of Lean Six Sigma Methodologies
  • Equipment commissioning/installation and troubleshooting
  • Validation including process/equipment qualification/sterilization/packaging
  • Continuous improvement activities including complaint handling investigations and corrective/preventive action
  • Risk Management (ISO 31000)
Compliance Management Solutions
Melbourne, Australia

E: [email protected]

M: +61 433 124 266

W: https://compliancems.com.au