Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ)

The Government of Canada is transitioning to the Medical Device Single Audit Program (MDSAP). Among other benefits, this will support Canadian companies in expanding their business to other markets and reduce red tape for those wishing to operate in multiple markets.

As Health Canada moves from the current Canadian Medical Devices Conformity Assessment System (CMDCAS ) towards the Medical Device Single Audit Program, Health Canada has received requests for clarification about its Transition Plan.  In response, this Frequently Asked Questions document has been drafted to address concerns and questions stakeholders may have.

Q1: I received a medical device licence using a Canadian Medical Device Conformity Assessment System certificate. Will my licence be suspended if I don’t have a Medical Device Single Audit Program certificate on January 1, 2019?

A1. All manufacturers of class II, III, and IV medical devices sold in Canada are required to transition to the Medical Device Single Audit Program. To maintain your medical device licences active, you must submit documented evidence of your transition to the Medical Devices Bureau by December 31, 2018.

To help manufacturers with this transition, Health Canada has introduced changes to the Medical Device Single Audit Program to provide more transition options. A notice outlining these changes is available. Depending on the option you select, you will need to submit appropriate documentation to Health Canada to show that you have undertaken the transition (see Q2, Q3, and Q4).

Medical device licences may be suspended if manufacturers are not able to demonstrate that they have undertaken the transition to the Medical Device Single Audit Program (as per section 40(1)(f) of the Medical Devices Regulations).

Q2: I am completing the transition to Medical Device Single Audit Program in 2018.  What do I have to submit to Health Canada to show that I have undertaken this transition?

A2. Manufactures undergoing a full Medical Device Single Audit Program audit (initial or recertification) in 2018 must submit a copy of a valid Medical Device Single Audit Program certificate with a completed F202 form to the Medical Devices Bureau by December 31, 2018.

Q3. I am completing the transition to the Medical Device Single Audit Program in 2019.  What do I have to submit to Health Canada to show that I have undertaken this transition?

A3. Manufacturers expecting to undergo a Medical Device Single Audit Program audit (initial or recertification) during the 2019 calendar year must provide the following documents to the Medical Devices Bureau with a completed F202 form by December 31, 2018:

  1. An ISO 13485 certificate issued under Canadian Medical Devices Conformity Assessment System valid until at least December 31, 2018.
  2. An ISO 13485 certificate (non-Canadian Medical Devices Conformity Assessment System) issued by a Medical Device Single Audit Program Auditing Organisation (AO) valid from January 1, 2019 onward.
  3. Documented evidence that they have made firm arrangements to undergo a Medical Device Single Audit Program audit (initial or recertification) in 2019 (e.g. signed certification agreement, written confirmation from the Auditing Organisation on letterhead, or completed Medical Device Single Audit Program form.

Note: these three documents must be submitted as a single PDF file, in the order listed above, along with a completed F202 form, to the following email address: hc.qs.mdb.sc@canada.ca. Please use the following subject line: MDSAP Transition Plan.

Auditing organisations can issue an ISO 13485 certificate (non-Canadian Medical Devices Conformity Assessment System) with a validity period beyond December 31, 2018 based on the existing certification cycle.

Q4. I am transitioning to the Medical Device Single Audit Program during a Surveillance Audit in 2018 or 2019. What do I have to submit to Health Canada?

A4. Manufacturers choosing to transition during a surveillance audit must provide the following documents to the Medical Devices Bureau with a completed F202 form by December 31, 2018:

  1. An ISO 13485 certificate issued under Canadian Medical Devices Conformity Assessment System valid until at least December 31, 2018.
  2. An ISO 13485 certificate (non-Canadian Medical Devices Conformity Assessment System) issued by a Medical Device Single Audit Program Auditing Organisation valid from January 1, 2019 onward.
  3. A Medical Device Single Audit Program Surveillance Audit Confirmation Notification for a Medical Device Single Audit Program surveillance audit having taken place in 2018 (this notice should be prepared in accordance with the Medical Device Single Audit Program’s surveillance Audit Confirmation Notification Process).

Or

Documented evidence that they have made firm arrangements to undergo a Medical Device Single Audit Program surveillance audit in 2019 (e.g. signed certification agreement, written confirmation from the Auditing Organisation on letterhead, or completed F0029.1 form.

Note: these three documents must be submitted as a single PDF file, in the order listed above, along with a completed F202 form, to the following email address: hc.qs.mdb.sc@canada.ca. Please use the following subject line: MDSAP Transition Plan.

Auditing organisations can issue an ISO 13485 certificate (non-Canadian Medical Devices Conformity Assessment System) with a validity period beyond December 31, 2018 based on the existing certification cycle.

Q5: What happens if I submit a device licence application with a Canadian Medical Device Conformity Assessment System certificate after January 1, 2019?

A5: Medical device licence applications containing Canadian Medical Devices Conformity Assessment System 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.

However, manufacturers choosing to transition to the Medical Device Single Audit Program during a surveillance audit will be required to submit a Canadian Medical Devices Conformity Assessment System certificate with their transition documentation (see Question 2 above) in lieu of a Medical Device Single Audit Program certificate.

Q6: I sell devices only in Canada. Do I still need a Medical Device Single Audit Program certificate?

A6: Yes. All manufacturers of Class II, III, and IV devices must transition from the Canadian Medical Device Conformity Assessment System to Medical Device Single Audit Program. For manufacturers that sell only in Canada, the regulatory requirements of the other Medical Device Single Audit Program countries (Australia, Brazil, Japan, and United States) will not be audited.

Q7: I am a Distributor / Retailer / Private Label manufacturer. Do I still need a Medical Device Single Audit Program certificate?

A7: No. Distributors , retailers and private label manufacturers do not need a Medical Device Single Audit Program certificate. However, the Original Equipment Manufacturer (the company that manufactures your device) is subject to the Medical Device Single Audit Program requirements. If the Original Equipment Manufacturer does not plan to transition to Medical Device Single Audit Program and the licence(s) are cancelled, the product may not be sold or advertised, including stockpiled product (Sections 26 and 27 of the Medical Devices Regulations).

Q8: My Canadian Medical Device Conformity Assessment System certificate doesn’t expire until after January 1, 2019. What do I do?

A8: You should contact your Auditing Organization and indicate that you wish to transition to the Medical Device Single Audit Program. This may require an early re-certification audit.  Please note that as of January 1, 2019, the Canadian Medical Devices Conformity Assessment System program will end and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted by Health Canada. 

Q9: What is the difference between a “recognized” and “authorized” Auditing Organization? Can both fully perform Medical Device Single Audit Program audits?

A9: Both recognized and authorized Auditing Organizations are approved and can issue Medical Device Single Audit Program certificates that Health Canada will accept. All Health Canada registrars have now been authorized or recognized to perform Medical Device Single Audit Program audits. The list of authorized and recognized Auditing Organizations.

Q10: What will the fees be for a Medical Device Single Audit Program certificate? If I can’t afford it, can Health Canada provide a grace period and still accept my Canadian Medical Device Conformity Assessment System certificate?

A10: Health Canada makes every effort to accommodate the needs of small businesses when introducing new regulatory requirements.

The Medical Device Single Audit Program Transition Plan was introduced three years ago to give manufacturers time to plan and prepare  for the transition from Canadian Medical Devices Conformity Assessment System to Medical Device Single Audit Program. 

As of January 1, 2019, the Canadian Medical Devices Conformity Assessment System program will end and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted. However, the Department has provided clarification on the transition and has announced modifications to the transition process that will make it easier for manufacturers to transition to Medical Device Single Audit Program. The details of these modifications were published on April 13, 2018 on the Health Canada website.

Your Auditing Organization will also be able to provide more information on fees and related services.

Health Canada remains committed to the smooth transition from Canadian Medical Devices Conformity Assessment System to Medical Device Single Audit Program. We are committed to ensuring that Canadians have access to safe and effective medical devices. The Department is working towards reducing regulatory burden on the medical device industry by collaborating with our international partners. If this Frequently Asked Questions document does not answer your questions, please direct them to:

Quality Systems Division
Medical Devices Bureau
Health Canada
Holland Cross, Tower A
11 Holland Avenue
Address Locator:
3005B
Telephone: 613-948-7194
E-mail: hc.qs.mdb.sc@canada.ca

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