Selected Australian resources for medical device, pharmaceutical and research businesses.
Links to external organisations are provided for convenience and general background only. Mercantile’s service is insurance broking; we do not interpret regulatory requirements or assess compliance. Listing an organisation does not imply endorsement or membership.
Australian organisations
Optional external resources for general background. These links do not form part of our insurance advice and do not confirm which requirements apply to your business.
- Therapeutic Goods Administration
Official organisation website. - Australian Pesticides and Veterinary Medicines Authority
Official organisation website. - Office of the Gene Technology Regulator
Official organisation website.
Research, laboratories and clinical governance
- National Association of Testing Authorities
Laboratory accreditation programmes and accredited facility information. - National Health and Medical Research Council
Australian research ethics, guidance and funding information. - Australian Commission on Safety and Quality in Health Care
Clinical governance and healthcare safety resources.
Business responsibilities and industry resources
- Food Standards Australia New Zealand
Food standards relevant to products regulated as foods. - Australian Competition and Consumer Commission
Product safety and supply-chain responsibility information. - Office of the Australian Information Commissioner
Privacy obligations, data breaches and health information resources. - Safe Work Australia
National workplace health and safety policy and guidance. - IP Australia
Patents, trade marks and intellectual property information. - AusBiotech
Australian biotechnology industry information and events. - Medical Technology Association of Australia
Medical technology industry information and policy resources. - Medicines Australia
Research-based pharmaceutical industry resources and codes.
Additional resources
For product-specific regulatory questions, speak with your regulatory adviser or the relevant authority.
https://www.fda.gov/home The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products
https://www.australianclinicaltrials.gov.au/ AustralianClinicalTrials.gov.au is a joint initiative between the National Health and Medical Research Council and the Department of Industry, Innovation and Science to provide information and resources to consumers, health care providers, researchers and industry about clinical trials.
https://www.chubb.com/au-en/business/life-science-industry.aspx?&gclid=EAIaIQobChMI3e2UgNXI5wIVFqqWCh1D-w7AEAAYASAAEgLSuvD_BwE Many of the world’s leading and upcoming life sciences companies trust their insurance to Chubb. Globally, we have been specialists in this niche insurance sector for more than 25 years.