№ lp_1_2_62601
Regulatory guidance and administrative instructions governing amendments to existing Canadian medical device licences for non-significant catalogue or model number changes under federal regulations.
Jurisdiction: Canada
Authority: Health Canada
Directorate: Medical Devices Directorate
Document type: Regulatory guidance and administrative instructions
Regulatory framework: Medical Devices Regulations
Regulations issued: July 1998
Subject matter: Amendments for non-significant additions or deletions of catalogue or model numbers
Application scope: Sections 28 to 31 and Section 34 of the Medical Devices Regulations
Exclusions: Private Label licences
Submission requirements: Fax-back form with copy of page 1 of the applicable licence
Processing timeframe: 7 calendar days from receipt
Authorization effect: Amended licence authorizes sale of listed devices and catalogue numbers
Related guidance: Guidance for the Interpretation of Significant Change; Guidance for the Interpretation of Sections 28 to 31
Administrative source: Medical Devices Directorate, Health Canada
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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