Arazy Group will host Health Canada in a conference call at <g class="gr_ gr_23 gr-alert gr_gramm gr_inline_cards gr_run_anim Style multiReplace" id="23" data-gr-id="23">10AM</g> EST on December 12, <g class="gr_ gr_22 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="22" data-gr-id="22">2018</g> with medical device industry participants to answer individual questions and provide clarification and instructions for transitioning from CMDCAS to MDSAP.
During the conference call, Health Canada will speak with individual manufactures to try and understand their unique situations and find tailored solutions to prevent manufacturers from being at risk of license suspensions. Each manufacturer faces individual unique challenges with the transition which may include costs, time, or AO (Auditing Organization) scheduling. Not all manufacturers will have MDSAP certification completed by the deadline December 31, 2018.
To participate register here: https://attendee.gotowebinar.com/register/5468561113840101123
During 2018 Health Canada has published instructions for providing "Transition Packages" in lieu of an MDSAP certificate for manufacturers that will not have MDSAP Certification completed by December 31, 2018.
These packages include <g class="gr_ gr_18 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling" id="18" data-gr-id="18">non</g>-CMDCAS ISO 13485 certificates and Audit Date Confirmation Letters from a recognized AO documenting an audit date during 2019 as long as the <g class="gr_ gr_17 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="17" data-gr-id="17">non</g>-CMDCAS ISO 13485 certificate does not expire before the audit date.
Manufacturers that do not submit an MDSAP Certificate or "Transition Package" by December 31, <g class="gr_ gr_19 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="19" data-gr-id="19">2018</g> will have their medical device licenses subject to suspension under section 40(1)(f) of the Medical Devices Regulations.
<g class="gr_ gr_25 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="25" data-gr-id="25"><g class="gr_ gr_24 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins multiReplace replaceWithoutSep replaceWithoutSep" id="24" data-gr-id="24">As</g></g> December 31, <g class="gr_ gr_26 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="26" data-gr-id="26">2018</g> quickly approaches the Arazy Group realizes that the options to submit an MDSAP Certificate or "Transition Package" by December 31 may not be feasible for all manufacturers. For varying <g class="gr_ gr_27 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="27" data-gr-id="27">reasons</g> manufacturers may need customized solutions for their individual situations.
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Benjamin Arazy
President and C.E.O
Vancouver BC
Canada
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