AGCI recently spoke with Health Canada regarding modifications to the MDSAP transition process that could affect manufacturers within the coming months, here is what we learned:
Health Canada recently published guidance requiring medical device manufacturers to transition from CMDCAS Certification to MDSAP Certification by January 1, 2019.
Health Canada recently announced modifications to the transition process that will make it easier for certain CMDCAS holders to transition to MDSAP using their current CMDCAS certification cycle, as long as all the following conditions are met:
* Manufacturer received ISO 13485/CMDCAS certification on or after January 1, 2016 through a certification or recertification audit, and
* The ISO 13485/CMDCAS certificate was issued by a Recognized MDSAP AO (Auditing Organization)* which does not expire on or before January 1, 2019, and
* Manufacturer has either undergone an MDSAP surveillance audit by the Recognized MDSAP AO* before January 1, 2019, Or
* Manufacturer has scheduled an MDSAP surveillance audit with the Recognized MDSAP AO* before January 1, 2019 with an audit date confirmed before April 1, 2019.
AGCI has been informed that health Canada will not take action against a manufacturer who due to scheduling challenges will not be audited to MDSAP before the end of Q1 2019
* List of AOs Recognized by Health Canada at the time of this press release: BSI Group America Inc, DEKRA Certification B.V., Intertek Testing Services NA Inc., Lloyd's Register Quality Assurance Inc., SGS United Kingdom Ltd., TÜV SÜD America Inc., UL Medical and Regulatory Services UL, LLC. List does not include organizations that are authorized to conduct audits but are not yet recognized by HC.
Although the process described above does not exclude new devices not yet certified under CMDCAS, ACGI recently spoke with several Recognized AOs and learned that many AOs have fully converted to MDSAP and are no longer issuing CMDCAS certifications. Therefore, if you do not already have an ISO 13485/CMDCAS certification this option may not be available to you.
If you would like assistance submitting the necessary documentation and forms to Health Canada before the January 1, 2019 deadline, or would like help contacting one of the Recognized AOs listed, please let your local AGCI representative now. http://arazygroup.com/contact-us.