ANSWERED ON THIS PAGE:
- Does ISO 13485 certification meet QMS requirements in Canada?
- How will ISO 13485:2016 and the MDSAP affect QMS requirements in Canada?
- Which device classifications require ISO 13485 certification?
Quality system compliance to the ISO 13485 standard is expected in many medical device markets it is not enough in Canada. Health Canada currently requires compliance to the Medical Device Single Audit Program (MDSAP), which includes additional QMS procedures and regulatory requirements before they will approve your device for sale.
Canada QMS requirements for medical device companies
Manufacturers of medical devices classified as Class II, III, and IV must demonstrate compliance with ISO 13485 under MDSAP. MDSAP includes compliance with the QMS requirements of the Canadian Medical Devices Regulations (CMDR). Certification of your MDSAP-compliant quality system by a Health Canada and MDSAP-accredited Auditing Organization (AO) is also required before your device can be sold in Canada. MDSAP compliance is effective as of January 1, 2019.
Already selling in Europe? We can help with ISO 13485 and MDSAP compliance for Canada
If you have already implemented ISO 13485 to sell in Europe and now want to sell in Canada, we can help you upgrade your QMS to meet all MDSAP requirements. We will build on your existing ISO 13485 quality system and add specific procedures and documentation necessary to comply with MDSAP. And, we can help you ensure your ISO 13485 certification is issued by a MDSAP-accredited AO.
Why choose Emergo for your Canadian ISO 13485 QMS upgrade?
- Emergo specializes in medical device regulatory compliance.
- Our consultants in Canada have assisted medical device companies worldwide with QMS compliance to ISO 13485 and MDSAP.
- An Emergo quality system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets.
- In addition to ISO 13485 consulting, we can assist with medical device licenses and establishment licensing in Canada.
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.
Common CMDCAS, MDSAP and Canadian QMS questions
What is the QMS requirement for Class I devices?
Manufacturers of Class I devices that are not sold directly to the consumer must acquire a Medical Device Establishment License (MDEL). The MDEL requires companies to have documented procedures in place that meet the CMDR related to distribution records, complaint handling, recalls, mandatory problem reporting, and (as applicable) for handling, storage, delivery, installation, servicing and corrective action. Health Canada periodically inspects MDEL holders to ensure these procedures and records are maintained.
What is Health Canada's transition timeline for ISO 13485:2016?
Health Canada has adopted the standard and will be revising its guidances accordingly. Manufacturers selling in Canada must obtain their ISO 13485:2016 certificate by March 1, 2019 (source).
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.