Canada: Medical Device Single Audit Program (MDSAP) Transition Plan – FAQ issued
Health Canada prepares to start in 2017 the process of adopting the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS).
Medical Device Single Audit Program (MDSAP) allows device manufacturers to undergo a single audit to satisfy the quality requirements of five participating nations (the US, Australia, Brazil, Canada, and Japan), instead of facing many inspections from different regulators.
Health Canada received many questions for clarification about the MDSAP Transition Plan. In response, the Frequently Asked Questions (FAQ) document has been drafted to address concerns and questions stakeholders may have.
Health Canada is keen to fully integrate MDSAP into its regulatory framework by January 2019. Health Canada has warned that at the end of the transition period, i.e., from January 1, 2019 onwards, it would suspend all medical device licenses that are not supported by a MDSAP certificate.
To facilitate the transition process, CMDCAS registrars have been given the opportunity to apply to be recognized as MDSAP auditing organizations, however, only five of the 13 CMDCAS registrars have been formally recognized to perform MDSAP audits so far.
For the FAQ please go to: Medical Device Single Audit Program (MDSAP) Transition Plan – FAQ.
- EU: Revised Guidance on Clinical Evaluation – MEDDEV 2.7.1 (rev. 4)
- EU: MDR-Medical Device Regulation – consolidated text
- Germany: Regulation on unannounced audits
- Canada: Medical Device Single Audit Program (MDSAP) Transition Plan – FAQ issued
- Malaysia: Class A devices exempted from conformity assessment; some other devices from registration requirements