Canada:
Steps to Market
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Summary |
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Step
1.
Read Health Canada Guidance including specific standards that
must be met.
Step 2.
Identify the Indications for Use and classify
your device, then determine the type of
Pre-market Submission required and establish
the requirement for Clinical Trials. Note:
Investigational Testing Involving Human
Subjects require authorisation.
Step 3.
Collate the necessary data and ensure evidence
of device safety and performance. Apart from
Class 1 Devices, Quality Management Systems to
ISO13485 and ISO 13488 must be assessed by a
recognised Canadian Registrar.
Step 4.
Appoint a Canadian Distributor and complete the relevant
Pre-market Submissions.
Step 5.
Await clearance from Health Canada.
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Call George Buchan on +44 (0)1292 671555
for a confidential, no obligation
discussion.
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ISO Standards |
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Identifying and providing
support to ensure compliance with Health
Canada and ISO Standards such as
ISO13485:2003, for Medical
Device design, manufacture, packaging,
sterilisation and labelling and post market
surveillance.
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Regulatory |
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Defining and ensuring
documentary evidence of compliance with Canadian
Medical Device Compliance Assessment System, (CMDCAS).
Preparing regulatory submissions to Health Canada.
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Quality /Documentation |
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Hands on
support to design and implement management
systems including: ISO13485:2003 and CMDCAS.
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