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 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 accredited by the SCC to ISO 13485:2016 and ISO 13485:2016 under Canadian Medical Device Conformity Assessment System (CMDCAS) requirements and 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 ISO 13485:2003 to ISO 13485:2016
On March 1, 2016, the International Organization for Standardization (ISO) published the revised version of ISO 13485 – ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes. This revised version will supersede ISO 13485:2003; the revised standard is referred to as ISO 13485:2016.
ISO will withdraw ISO 13485:2003 on March 1, 2019, three years after the publication of ISO 13485:2016. Health Canada has set March 1, 2019 as the transition date for ISO 13485:2016. All manufacturers of class II, III and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1, 2019.
In accordance with section 43.1 of the Medical Devices Regulations a manufacturer is required to submit to Health Canada a copy of any new or modified certificate within 30 days of the certificate being issued.
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. As announced by Health Canada, CMDCAS certificates will no longer be accepted after December 31st 2018, and manufacturers will be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to maintain their medical device licences.
Learn more about how LRQA can help you with MDSAP.
Why Choose LRQA for ISO 13485:2016 Certification under CMDCAS?
- Client focus and proven client satisfaction – 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.
Contact us to learn more about ISO 13485:2016 certification