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Guidance to apply for a Manufacturer's Certificate to Export licensed medical devices from Canada (GUI-0097) Version: 3 Date issued: January 18, 2023 Date implemented: January 18, 2023 Replaces: Guidance to apply for a Manufacturer's Certificate to Export licensed medical devices…

Frequently asked questions: Medical device establishment licensing and fees Disclaimer This document does not constitute part of the Food and Drugs Act or its regulations, and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act…

COVID-19 Medical Device Establishment Licence (MDEL) suspensions Health Canada issues Medical Device Establishment Licences (MDELs) to: companies that import, distribute or manufacture Class I devices, such as masks, respirators, eye protection, gowns and swabs importers and…

Contract Sterilization letter (PDF Version - 124 KB) Health Products and Food Branch Inspectorate 2nd Floor, Graham Spry Building 250 Lanark Avenue A.L. 2002A Ottawa, Ontario K1A 0K9 September 1, 2009 To: Establishment Licence Holders Re: Contract sterilization of primary…

Drug Establishment Good Manufacturing Practices - Pre-Application Package (Importers, Distributors and Wholesalers) (PDF Version - 842 K) Contact Information Our Mandate : To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and…

Fees for the Review of Human and Veterinary Drug Establishment Licence Applications Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide assistance to…

How to Pay Your Establishment License Fees Notice to reader: This is an archived page. Please refer to the most current version of this page. For your convenience, Health Canada accepts cheques, credit cards, and wire transfer. To avoid over or underpayment, please submit your…

How to Pay Fees to Health Products and Food Branch (HPFB) Notice to Reader: This is an archived page. Please refer to the most current version of this page. Contact: Cost Recovery ( Office of Submissions and Intellectual Property ) Fee payable to Health Canada (HC) must be paid…

Drug Establishment Licence - Calculation Chart The Calculation Chart is used to estimate the total fees for a Drug Establishment licence. In order to obtain a copy of the Drug Establishment Licence Fee Calculation Chart or for any additional information, please contact the Cost…

ARCHIVED Drug Establishment Licence Application Completion Checklist This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below. Help on accessing…