Other

  • MSAC Applications                                                                                          

  • Advantage MPC can assist you with preparation of applications to the Medical Services Advisory Committee (MSAC). Evaluation of evidence associated with medical services has been an integral part of the process for the listing of new medical technologies and services on the Medicare Benefits Schedule (MBS) 

  • Exempted Products

Advantage MPC can help you ensure that products exempted from controls under the Therapeutic Goods Act and Regulations are presented in accordance with the relevant provisions and Orders.  Hand sanitisers, oral and personal hygeine products, and skin care products are exempted provided they do not make health claims.  (These products are still required to meet Cosmetic regulations.)

  • Clinical Trials

Advantage MPC can assist you with the Regulatory aspects of Clinical Trials, Clinical Trial Notifications (CTN) and entry of your trial on the Australian & New Zealand Clinical Trials Register.

  • Food products

Foods sold in Australia must meet the Australia New Zealand Food Standards Code.  Advantage MPC can help you with deciding whether a product is food or medicine.  Generally no health claims are permitted on foods unless specifically approved by the Regulator.   We can advise on food labelling.  

  • In vitro diagnostic goods (IVD)

New Regulations requiring the entry of IVD on to the Australian register of Therapeutic Goods will commence in Australia from 1 July, 2010.

The new regulations, which come into force on July 1st 2010, are intended to provide the mechanism for the regulation of all in vitro diagnostic devices supplied in Australia. Until now only a very limited range of IVDs have required pre-market regulatory approval and inclusion on the Australian Register of Therapeutic Goods (ARTG). Under the new regulatory scheme, which consists of amendments to the existing Medical Device Regulations, all new IVDs will be required to be included on the ARTG before they can be supplied in Australia.

Products currently supplied in Australia will have a 4 year transition period to enable sponsors and manufacturers to make application for their inclusion onto the ARTG.

The regulatory framework is quite different to the current European and US systems. IVDs will be classified into 4 classes based on assessed personal and public health risk, with the highest risk products being included in Class 4 and lower risk products in Classes 3, 2 and 1. The assignment of products by manufacturers into a particular risk Class will be based on a series of classification rules which are written into the Regulations.

A number of products will still remain exempt from inclusion;

Advantage MPC can advise and assist you to meet your regulatory obligations. 

  • Other Therapeutic Goods

Sterilants, disinfectants, tampons, menstrual cups etc. are regulated as therapeutic goods and Advantage MPC can help you meet you regulatory obligations for these products.

  • Poisons scheduling

Advantage MPC can advise on poisons scheduling and other issues affecting distribution of your products, including State & territory Health legislation. 

  • Labelling & Packing

We can advise on the correct labelling and packaging of your therapeutic, cosmetic or food products.

  • Quarantine

Advantage MPC can help you with Quarantine issues affecting your medical and health products.

Please complete and email or fax us the ADVANTAGE MPC  Free Online Consultation Form.