Illinois Orthopedic Device Business Sells Direct to Patients in Australia

Cast21 is a start-up orthopedic device manufacturer of waterproof alternative casts and is a tenant of Chicago’s mHUB incubator for early- stage innovative manufacturers.

Cast21 wanted to register their medical device and sell directly to end user patients in Australia.  They specifically asked for assistance connecting with the Therapeutic Goods Administration, the FDA equivalent in Australia, for guidance on regulatory requirements for imports.

U.S. Commercial Service (CS) Chicago counseled the company on export resources and worked with CS Australia to get connected to Australia’s Therapeutic Goods Administration and assist Cast21 in getting registered.  In addition, CS Australia provided the company with a better understanding of the import registration requirements for medical devices.  Once registered, Cast21’s account with TGA allowed Australian patients to directly import Cast21 products from the U.S. under a direct sales transaction to end users.

“[The} Commercial Service is awesome and Monica knows who to connect with to provide very helpful resources.” – Ashley Moy

As a result of counseling, market intelligence, and resources provided by CS Australia and CS Chicago, the client confirmed their success in entering and selling to the Australian market.