CMDCAS, MDSAP and Health Canada ISO 13485 QMS Compliance
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. However, ISO 13485 compliance is not enough in Canada. Health Canada currently requires compliance to 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 as well as the Canadian Medical Devices Regulations (CMDR). Certification of your CMDR-compliant quality system by a Health Canada accredited registrar is also required before your device can be sold in Canada.
Already selling in Europe? We can help with Canada ISO 13485 and CMDR compliance
If you 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 CMDR requirements. We will build on your existing ISO 13485 system and add specific procedures and documentation necessary to comply with the CMDR. We can help you ensure your ISO 13485 certification is issued by a Health Canada accredited registrar.
Why choose Emergo for your Canadian ISO 13485 QMS upgrade?
- Emergo specializes in medical device regulatory compliance.
- Our offices in Canada have assisted medical device companies worldwide with QMS compliance to ISO 13485 and Health Canada CMDR.
- An Emergo quality system complies not only with Canadian ISO 13485, but also additional medical device regulatory requirements in many other markets.
- In addition to ISO 13485 consulting, we can assist with medical device licenses in Canada.
- In most cases we charge a fixed fee for Canada ISO 13485 upgrades.
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 Canadian Medical Devices Regulations (CMDR) (where applicable) 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 the MDEL holder to ensure these procedures 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. Health Canada will limit the transition period to December 31, 2018 to coincide with the transition to Medical Device Single Audit Program (MDSAP). Manufacturers selling in Canada must obtain their ISO 13485:2016 certificate by January 1, 2019.
What about Health Canada's participation in the MDSAP?
Health Canada intends to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the QMS requirements of the CMDR. MDSAP will thus replace the existing Canadian Medical Device Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin January 1, 2017, and will span two years. During this period, Health Canada will accept certificates issued under either CMDCAS or MDSAP.
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. Read more about this.