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Health Canada MDEL Holder's Regulations and How we can help?
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Health Canada’s expectation as a MDEL holder is that you are following the good practices (GMP) to ensure the quality of the products you distribute. These practices are demonstrated by following procedures and completing forms associated with these procedures.
Health Canada will ask you to provide the application form you completed to get your establishment licence. The inspector will then verify that the following information in your application form is accurate:
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Manufacture, distribution and import activities
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Name and address of manufacturers of devices you import or distribute
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Documented procedures for:
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Distribution records
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Handling complaints
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Recalls
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Mandatory problem reporting (if you are an importer)
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Handling, storing, delivering, installing, correcting and servicing any Class II, III or IV device (for importers and distributors when applicable)
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Health Canada will review your procedures to ensure you are using them and they are adequate. If you do not have procedures, or they are inadequate, your company will not be considered compliant with certain sections of the Regulations.
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MedTechGuys can assist you with preparing standard operating procedures (SOPs) so your business adheres to such practices as product disposition, adverse reaction reporting, quality complaint handling, recall and recall reporting, documentation and other SOPs.
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