Medical Device Regulations

I’ve created this step-by-step guide to bringing a medical device to market. The goal is to give you a go-to guide that is easy to follow, can point you in the right direction, and will ultimately set you up for a successful product launch. So, let’s get started…

The Global Harmonization Task Force: www.ghtf.org It provides general information and reports from the four study groups. It also offers an extensive list of web sites of countries around the world. Australia: Therapeutic Goods Administration: www.health.gov.au/tga Canada: Health Canada site: www.hc-sc.gc.ca All medical devices guidance documents and medical device related information can be obtained from