April 27, 2011
Spring Achieves Canadian Medical Devices Conformity Assessment System Certification
D. Medical Industries Ltd. announced today that its subsidiaries, Spring Health Solutions Ltd. and Spring-Set Health Solutions Ltd. ("Spring-Set"), have received Canadian Medical Devices Conformity Assessment System (CMDCAS) certification for its ISO 13485:2003 Quality System. As a result, Spring-Set is now in the process of filing an application for Health Canada approval for the Company's Universal Detach Detect Infusion Sets which Spring-Set designs and markets.
Manufacturers of medical devices that wish to sell their products in Canada must submit their devices for licensing by Health Canada. Health Canada reviews the product for safety, effectiveness, and quality, relying on CMDCAS recognized registrars to ensure that manufacturers have an adequate quality system. CMDCAS recognized registrars audit a medical device manufacturer's quality system to ISO 13485:2003 with the implementation of requirements from the Canadian medical device regulations, then provide a certificate of registration. Manufacturers then use this certificate as part of the submission for a device license with Health Canada.
"Achieving CMDCAS accreditation is a further endorsement of our approach to quality management. It will also allow us to move forward with the registration and commercialization of products – starting with our Universal Detach Detect Infusion Sets - in Canada, a country that has the sixth highest incidence rate of Type 1 diabetes in children 14 years or younger in the world," said Efri Argaman, D. Medical's Chief Executive Officer.