Why not ask directly the Medical Devices Bureau? Here is the contact:
: MDB_Enquiries@hc-sc.gc.caTelephone: 613-957-4786Fax: 613-957-6345
I would advise to call directly and, if necessary, set up a teleconference or an in-person meeting.
AK
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Agnes Klein MD, PhD
Biologics and Genetic Therapies Directorate
Ottawa ON
Canada
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