ISO 13485 and GMDCAS

GMDCAS stands for “Global Medical Device Conformity Assessment System”, a program initiated by the International Accreditation Forum (IAF).

As many as 150 countries have no medical device regulations. Several of these countries are considering establishing their own, unique regulatory requirements, with more countries to follow. As a result, there is a strong need to develop a third party accreditation program that can be used by all countries.

Since these countries rely heavily on imported medical devices, their development of national QMS accreditation requirements could cause a serious adverse impact on that country’s local healthcare system. Why? Because most medical device manufacturers cannot justify making special accommodations for a single, small market. In addition, many certification bodies might find it economically infeasible to apply for a separate accreditation for just a few clients.

Without a globally accredited QMS certification program for medical devices, the unintended consequence for these developing countries may be to lose their current access to healthcare technologies.

The IAF has established a Working Group for the ISO 13485 GMDCAS program. This group includes representatives from the United States, Canada, European Union, Australia, Japan, and China. It also includes industry experts in medical device regulations and standards. For more information, contact the Chairman of the IAF Working Group, Grant Ramaley, at (gramaley@aseptico.com).