TÜV Management Service First Global Registrar to Receive CMDCAS Recognition From the SCC
TÜV America Inc. announces that its registrar division, TÜV Management Service, has received accreditation from Standards Council of Canada (SCC) and Health Canada as a Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrar on August 8, 2001. CMDCAS recognition enables TÜV to perform accredited ISO 13485 / 13488 quality systems certification services for medical device manufacturers marketing their products in Canada through the Medical, Health and Sports division of TÜV Product Service. TÜV becomes the first registrar in the world to be CMDCAS recognized by Health Canada and the SCC to provide ISO 13485 / 13488 certification. Combined with TÜV Product Service’s full suite of medical services and status as the leading Notified Body for the EU Medical Devices Directive, clients can receive all their conformity assessment services from one leading organization.
To date, Health Canada is the first national regulatory body to require a specific quality systems standard, ISO 13485 / 88 as a prerequisite to device licensing requirements necessary to conduct business in Canada. Published on May 7, 1998 the device and establishment licensing requirements found in sections 43 and 44 of the Canadian MDR (Medical Device Regulations) came into force on January 1, 1998. The quality systems requirements found in sections 32 (2) (f), 3 (5) and 4 (p) due to come into effect July 1, 2001, have been amended and will now come into force eighteen months later on January 1, 2003. Beginning July 1, 2001, a voluntary transition period will begin for all manufacturers of applicable (class 2-4) medical devices in the Canadian marketplace to receive ISO 13485 / 88 by a CMDCAS recognized registrar (TÜV Management Service). As of January 1, 2003 manufacturers of class 2-4 medical devices not already in the Canadian market must submit an appropriate CMDCAS ISO 13485 / 88 quality system certificate to Health Canada along with their device license application. Annual renewal of the latter is required each November. Manufacturers whose class 2-4 devices are already licensed to market in Canada have until November 1, 2003 to submit appropriate CMDCAS ISO 13485 / 88 certificates with their renewal applications. (ISO 13485 and 13488:1996 are quality management standards specific to the medical device industry, which supplement ISO 9001 and ISO 9002:1994 quality management systems standards)
Canadian Requirements
To date, Health Canada is the first national regulatory body to require a specific quality systems standard, ISO 13485 / 88 as a prerequisite to device licensing requirements necessary to conduct business in Canada.
Manufacturers of Class 2 devices must comply with the requirements for ISO 13488 and manufacturers of Class 3 and 4 devices need to meet the requirements for ISO 13485. Accreditation to these standards must be achieved by a Health Canada recognized SCC accredited registrar. The SCC is deeming these registrars Canadian Medical Devices Conformity Assessment System (CMDCAS) registrars.
TÜV Management Service, the registrar division of TÜV America Inc., is the first registrar to receive accreditation by the SCC and Health Canada as a CMDCAS recognized registrar. This accreditation enables TÜV Management Service to provide clients ISO 13485 or ISO 13488 certification for medical device manufacturers selling their product in the Canadian marketplace. Combined with TÜV Product Service’s full suite of medical services and status as the leading Notified Body for the EU Medical Devices Directive, clients can receive all their conformity assessment services from one leading organization, TÜV Product Service.
About CMDCAS
Published May 7, 1998 the device and establishment licensing requirements found in sections 43 and 44 of the Canadian MDR (Medical Device Regulations) came into force on January 1, 1998. The quality systems requirements found in sections 32 (2) (f), 3 (5) and 4 (p) were due to come into effect July 1, 2001, have been amended and will now come into force eighteen months later on January 1, 2003. Beginning July 1, 2001, a voluntary transition period will begin for all manufacturers of applicable (class 2-4) medical devices in the Canadian marketplace to receive ISO 13485 / 88 by a CMDCAS recognized registrar (TÜV Management Service). As of January 1, 2003 manufacturers of class 2-4 medical devices not already on the Canadian market must submit an appropriate CMDCAS ISO 13485 / 88 quality system certificate to Health Canada along with their device license application. Annual renewal of the latter is required each November. Manufacturers whose class 2-4 devices are already licensed to market in Canada have until November 1, 2003 to submit appropriate CMDCAS ISO 13485 / 88 certificates with their renewal applications.