Regulatory & Reimbursement Services
Our regulatory services include:
- Provision of guidance documentation for medical device manufacturers wishing to enter the Australasian market.
- Preparation of manufacturer’s Declaration of Conformity to Australian regulations.
- Liaison with manufacturer to provide evidence of Good Manufacturing Practices for submission to the Australian Therapeutic Goods Administration (TGA).
- Preparation and lodgement of device applications with the TGA and ongoing communications with this organization.
- Mediation between device manufacturers and the TGA with regards to specific audit requirements.
- Preparation of device applications onto the New Zealand Web-Assisted Notification of Devices system (WAND).
- Advice on all requirements for entry into Asian medical device markets, including introduction to established international regulatory consultants.
Our reimbursement services include:
- Compilation of procedural banding applications to allow for the reimbursement of new surgical technologies within the private hospital system in Australia.
- Preparation and submission of Schedule 5 Applications for reimbursable prosthetic devices.
- Preparation of submissions to the Medicare Services and Advisory Committee (MSAC) for new Medicare item numbers (CPT codes) with respect to defining new surgical procedures.
- Liaison between regulatory bodies, manufacturers, sponsors and health funds to find reimbursement solutions.
- Comparative cost analysis.