As originally asked by Ann Marie Jahn Kessler.

For my current research I am trying to evaluate how medical device manufacturers may manage their international product registration best and if/how project and programme management methodoly is used in the process. The focus hereby is on markets outside the EU and US such as China, Japan, India, Brazil, Turkey etc.
Share your opinion and experience and let me know what you think are the biggest challenges for medical device companies going global.

Ted Haas
Architect and Taxonomy Master at UNSPSC
Cheers Ann Marie,
I would suggest you also include a deep troll through the web site www.imdrf.org (International Medical Device Regulators Forum) They are working through the process of standing up a globally linked network of medical Device auditing authorities. In terms of a simple explanation think of it as a confederation of the FDA around the world. It’s original form was something called the Global Harmonization Task Force. This should provide some interesting food for thought and possibly links to some of the countries you are interested in.

Regards

Ted Haas

Bruce Youngman
Dedicated to improving value
Ann Marie, a rather broad question as requirements vary by both the individual country as well as the medical device classification itself. All countries I have been working with require a local representative so this means finding and working with a distributor for products within the country or establishing a physical branch office there. Product registration tends to follow a pattern of providing product information, label & language requirements, device classification(s) and Quality Management System Information. Working through the import/export documentation needed for customs and taxation purposes is likely the biggest challenge.