Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ)
April 22, 2016
Our file number: 16-104576-806
Health Canada has received requests for clarification about the MDSAP Transition Plan from stakeholders as Health Canada moves towards the Medical Device Single Audit Program (MDSAP) from the Canadian Medical Devices Conformity Assessment System (CMDCAS). In response, this Frequently Asked Questions (FAQ) document has been drafted to address concerns and questions stakeholders may have. Any unanswered questions can be sent to the Medical Devices Bureau for further guidance. This document may be periodically updated as further information becomes available.
Q1: I received a medical device licence using a CMDCAS certificate. Will my licence be suspended if I don’t have a MDSAP certificate on January 1, 2019?
A: Yes. Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension. Holding a valid quality systems certificate is a regulatory requirement for a manufacturer to have an active medical device licence. All device licence applications and F202 notifications received after January 1, 2019, must contain a MDSAP certificate; a manufacturer’s CMDCAS certificate will not be accepted. Additionally, auditing organizations (AOs) will soon begin issuing MDSAP certificates after recertification or special upgrade audits and these are to be submitted to Health Canada using the Form F202 notification process.
Q2: What happens if I submit a device licence application with a CMDCAS certificate after January 1, 2019?
A: As stated in the transition plan, medical device licence applications containing CMDCAS certificates will not be accepted after January 1, 2019. Applications that contain these certificates will be issued a screening deficiency letter as per the Management of Applications for Medical Device Licences and Investigational Testing Authorizations policy.
Q3: I passed my audit but my AO said it will take a while for the MDSAP certificate to be issued. Can I submit the audit report or pass confirmation in lieu of the certificate with my device licence application/F202 and submit the certificate when I receive it?
A: No. Health Canada will only accept the certificate as evidence of compliance with the quality management system requirements.
Q4: I sell devices only in Canada. Do I still need the MDSAP certificate?
A: Yes. All manufacturers must transition from CMDCAS to MDSAP certificates to meet the quality management system requirements of the Medical Devices Regulations. For manufacturers who only sell in Canada, the regulatory requirements of the other MDSAP participants (United States, Brazil, Australia, and Japan) will not be audited. Distributors and retailers are not subject to the quality management system requirements.
Q5: I have a CMDCAS certificate. Will my next audit be a MDSAP audit?
A: This will depend on the AO; some have performed MDSAP audits in place of CMDCAS surveillance audits. Please contact your AO to see if this is an option.
Q6: I just had my recertification audit and received a CMDCAS certificate. Will I be issued a MDSAP certificate to replace it?
A: This will depend on the AO. You should contact your AO and inquire about transitioning your certification under CMDCAS to one under MDSAP.
Q7: I have a recertification audit scheduled for 2017/2018. Will I be receiving a CMDCAS or a MDSAP certificate? If I receive a CMDCAS certificate will I need another audit to receive the MDSAP certificate?
A: You should discuss this matter with your AO to ensure that you eventually transition to MDSAP before January 1, 2019. Depending on your circumstances, you may need an additional audit to complete the transition to MDSAP.
Q8: My CMDCAS certificate doesn’t expire until after January 1, 2019. What do I do?
A: You should contact your AO and indicate that you wish to transition to MDSAP. This may require an early re-certification audit.
Q9: My CMDCAS registrar is not approved as an AO. How long should I wait before switching to an approved AO?
A: All CMDCAS registrars have stated their intention to become approved AOs. If your registrar is currently not approved, please contact them to enquire when they expect to receive their approval. The list of approved AOs can be found here.
Q10: What will the fees be for a MDSAP certificate? If I can’t afford it, can Health Canada provide a grace period and still accept my CMDCAS certificate?
A: Please contact your AO for information on fees and services. Health Canada will not be offering a grace period for manufacturers; the transition plan announcement gives manufacturers three years to plan and prepare, which Health Canada feels is sufficient time. As of January 1, 2019, all medical device licence applications and F202 notifications must be accompanied by an MDSAP certificate.
Health Canada remains committed to the smooth transition from CMDCAS to MDSAP and providing Canadians with safe and effective medical devices while collaborating with our international partners to reduce regulatory burden on the medical device industry. If this FAQ does not answer your questions, please direct them to
Quality Systems Division
Medical Devices Bureau
2934 Baseline Road, Tower B
Address Locator: 3403A
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