Standard operating procedure for Businesses to adhere with Health Canada Medical Device Regulations.
 
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:
You may be asked for:​
Medical Device Regulation's Complaint Documented procedures for:
 
 
Distribution records
 
Handling complaints
 
Recalls
 
Mandatory problem/incident reporting
 
 
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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.
 
​MedTechGuys has prepared this document which serves as a template only for standard operating procedures (SOPs) that deals with all Sections of MDR, so your business adheres to such practices and Regulations.
 
This bundle include documented procedures for Class I devices:
Distribution records
 
Handling complaints
 
Recalls
 
Mandatory problem/Incident reporting
 
 
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Disclaimer
 
This document is a strictly confidential communication to and solely for the use of the recipient/buyer and may not be circulated or resold without TransCanada Tradelinks & MedTech Guys’s prior consent. If you are not the intended recipient, you may not disclose or use the information in this documentation.
The information provided by MedTech Guys (“we,” “us” or “our”) in this document is for general informational purposes only and can only be used as a template/Guideline only and not as a professional advice. All information in this document is provided in good faith, however we make no representation or warranty of any kind, express or implied, regarding the accuracy, adequacy, validity, reliability, availability or completeness of any information in this document
Under no circumstance shall we have any liability to you for any loss or damage of any kind incurred as a result of the use of the document or reliance on any information provided in the document. Your use of the document and your reliance on any information in it is solely at your own risk.