Within the Medical Device Single Audit Programs (MDSAP) medical device manufacturer can be audited in a single audit for access to the following markets:
MDSAP audits are based on ISO 13485:2016 and include the respective requirements of the target markets. Note: "in addition to the exclusions and non-applications permitted by ISO 13485, the organization may exclude the requirements of markets where the organization does not intend to supply product" (see MDSAP Audit Model (AU P0002.004), page 6).
At the end of 2016 Health Canada decided to only accept CMDCAS certificates until the end of 2018. Manufacturers who are not able to provide an MDSAP certificate are "subject to compliance actions including the potential for cancellation" of the respective licences (see Notice: Medical Device Single Audit Program (MDSAP)). Thus, manufacturers of Canadian risk class II to IV medical devices need an MDSAP audit in order to get access to the Canadian market.