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Extended MDR Date of Application: Optimizing your PMS and clinical activities
Now that the European Medical Devices Regulation (MDR) final date of application has been pushed to May 2021, medical device manufacturers should
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Combination products use errors white paper
Combination products: common use errors and design considerations
Combination products, such as injection devices, inhalers, nebulizers, and drug patches, are increasingly being used by laypeople for self-
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Medical device registration in Australia and New Zealand
Medical Device Registration in Australia & New Zealand
Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key
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Get smart about Australia in 1 hour
If you are thinking about entering the Australian market for the first time, understanding the Therapeutic Goods Association (TGA) regulatory
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What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
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TGA - Australia Therapeutic Goods Administration
The Therapeutic Goods Administration is the Australian regulatory authority for therapeutic goods such as pharmaceuticals, blood products and tissues
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Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
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