Advantage Medical Products Consulting provides a unique service to give our clients the best opportunity for registering medical products and devices or bringing other products to market in Australia and New Zealand.
High standards and strict controls apply when it comes to registering new medical products for commercial use. This is a lengthy and time consuming process and many manufacturers, exporters and suppliers do not have the time or resources to adequately follow the protocol required by governments to register medical products.
Our advantage is that we have over thirty years experience in regulatory affairs. Bren Milsom, a registered pharmacist, worked for fifteen years with the Therapeutic Goods Administration (TGA). As a result we have a comprehensive understanding of the process and requirements of the TGA/MEDSAFE and other government agencies. Our expertise helps to fast track the registration process.
We provide guidance and advice on:
- TGA and MEDSAFE liaison
- Medicines and other therapeutic goods registration and listing
- Medical device conformity assessment and inclusion
- All TGA & Medsafe on-line systems ELF, DEAL, COMET(NZ), WAND (NZ), GMDN coding etc (FSANZ)
- Sunscreens, sports supplements, cosmetics and toiletries (NICNAS/ERMA)
- Advertising complaints, website compliance and pre-clearances
- Formulation, packaging and labelling
- Manufacturing, GMP compliance and site master files
- Importing and exporting
- Trade practices
- Problem reports and recalls
- Poisons scheduling
- AQIS Clearances
- Other government requirements