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 / 2^nd / 3^rd Party medical device/IVD auditor (EN ISO 13485 | IVD 98/79/EC | MDD 93/42/EEC | MDR | MDSAP)
3^rd Party (certification) medical device Notified Body auditor (DQS/LRQA/TUV SUD)
3^rd 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 1^st /2^nd / 3^rd 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 1^st /2^nd / 3^rd 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 | S – Compliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ)

M: +61 4 33 124266

E: [email protected]

W. compliancems.com.au