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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:

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 complimentary medicines indications evidence
  • TGA Therapeutic Goods Medical Device Regulations & ISO 13485 implementation and maintenance (Medical Devices including IVD’s), including training
  • FDA 510k/PMA/De Novo application preparation for medical devices and in vitro diagnostic products and maintenance in compliance with the 21 CFR Part 800
  • Technical File/Design Dossier preparation and maintenance in compliance with Council Directives – 93/42/EEC, MDR 2017/745, FDA 21 CFR Part 800 and Australian medical device Regulations
  • Technical File/Design Dossier preparation and maintenance in compliance with Council Directives –
  • 98/79/EC in vitro diagnostics, FDA 21 CFR Part 800 and Australian In Vitro Diagnostic Regulations
  • Medical Device/IVD Testing to International/Harmonized Standards (Active/Non-active)
  • 1st / 2nd / 3rd Party medical device/IVD auditor (EN ISO 13485 | IVD 98/79/EC | MDD 93/42/EEC  | MDR | MDSAP)
  • 3rd Party (certification) medical device Notified Body auditor (DQS/LRQA/TUV SUD)
  • 3rd Party (certification) medical device Technical File/Design Dossier reviewer (DQS/LRQA/TUV SUD)
  • International Authorised Representative (Australia, Europe, Vietnam, Singapore, Malaysia, NZ and more)
  • Risk Management ISO 14971 | ICH Q9

Cosmetics:

  • Cosmetics GMP ISO 22716 implementation and maintenance, including training
  • ISO 22716 1st /2nd / 3rd Party Audits
  • Cosmetics Label/Ingredients review for the 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

Miscellaneous:

  • Integrated Management Systems implementation and maintenance (ISO 9001 / OH&S / ENV), including training and 1st /2nd / 3rd Party Audits
  • 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)

George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer |

C | M | SCompliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ)

M: +61 4 33 124266

W: compliancems.com.au