As of 01 January 2003, the Canadian Medical Device Regulations came into force, affecting all organizations represented as the “legal manufacturer” of medical devices (including in-vitro diagnostic devices) currently selling or seeking to sell into Canada through the device licensing system. Health Canada’s national authority, the Therapeutic Products Directorate (TPD), handles regulation of devices sold into Canada and oversees the Canadian Medical Device Conformity Assessment System (CMDCAS).
Under this system, assessments and certification to ISO 13485:2003 must be performed by Standards Council of Canada (SCC) accredited registrars. Manufacturers can use this certification to demonstrate conformance with the quality system requirements of the Canadian Medical Devices Regulations.
LRQA is recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) in accordance with the requirements of Q90R0 Policy on CMDCAS.
Transition from CMDCAS to MDSAP.
On December 4, 2015, Health Canada confirmed the Medical Device Single Audit Program (MDSAP) will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin at the conclusion of the MDSAP Pilot on January 1, 2017, and will span a period of two years. During this two year period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted.
Health Canada has pledged its commitment to work with the Standards Council of Canada, recognized third party auditing organizations ("Registrars") and medical device manufacturers to ensure the smooth operation of both programs during the pilot and the subsequent transition to MDSAP.
Learn more about how LRQA can help you with MDSAP.
Over half of the world’s top 200 companies choose LRQA
LRQA is a respected, world renowned registrar accredited by the Standards Council of Canada (SCC) and recognized by Health Canada to deliver accredited ISO 13485 and CDMCAS certification.
LRQA is a market leader in the provision of assessment, certification and training services, and our Business Assurance approach ensures our assessments focus on the areas and issues that are important to your business.
Our medical assessors are industry specialists and experts who are matched with your business needs, enabling an effective and robust assessment of your system.
As the first certification body to gain accreditation for issuing quality management system certificates, we understand system requirements and can therefore tailor our approach to help meet your objectives.
Beyond certification, LRQA provides an extensive range of services to support your business’ future growth and development, including training solutions and integrated management systems assessment.
Why Choose LRQA for CMDCAS Certification?
- Client focus and proven client stisfaction – LRQA shares the same objectives as our clients - to help ensure safe and compliant products into the market as quickly as possible, thereby protecting consumers as well as the brands and reputations of our clients. LRQA medical device clients report a 92% satisfaction rating across key areas of our service.
- Accessibility to technical expertise – LRQA medical device experts are industry specialists who are available at any time and are only a phone call, text message or email away. Our medical assessors have some of the most extensive ISO 13485 experience in the world. Many are hand-selected to provide input into the work of the ISO technical committees and are able to provide first-hand insight into requirements of the standard and the standard’s logic.
- Globally recognized and accredited – LRQA is one of the world’s leading Notified Bodies, recognized for our technical contributions to industry regulations and standards development. More than half of the world’s top 200 companies choose LRQA. LRQA is accredited by the Standards Council of Canada (SCC) and recognized by Health Canada to deliver accredited ISO 13485 and CDMCAS certification.
- Impartiality and objectivity – With no shareholders of our own, we are independent and impartial in everything we do. We are committed to acting with integrity and objectivity at all times.
- Assessment methodology – LRQA helps you manage your systems and risks to improve and protect the current and future performance of your organization. Our approach is built on three pillars and extends the focus beyond the certificate to an assessment approach designed to help organizations meet their strategic objectives.
- Extended range of services – We offer you direct access to electrical safety testing, usability testing and much more.