Guidance document : medical device licence renewal and fees for the right to sell licensed medical devices / Health Products and Food Branch.: H13-9/21-2013E-PDF
"This guidance document provides medical device manufacturers and their regulatory correspondents with the steps involved in renewing a medical device licence. The renewal process has two purposes: the first is to confirm whether the medical device will continue to be sold in Canada and the medical device licence will remain active; the second is to collect information that must be assessed prior to invoicing for the right to sell fee. This guidance document also provides guidance on the Fees in Respect of Drugs and Medical Devices Regulations (Fee Regulations) with a focus on how the Fees for the Right to Sell Licensed Class II, III or IV Medical Devices, contained in Part 3, Division 3 of these regulations, will be administered"--Introduction, page 1.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.886859&sl=0
| Department/Agency | Canada. Health Canada. Canada. Health Products and Food Branch. |
|---|---|
| Title | Guidance document : medical device licence renewal and fees for the right to sell licensed medical devices / Health Products and Food Branch. |
| Variant title | Health Canada guidance document : medical device licence renewal and fees for the right to sell licensed medical devices |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Issued also in French under title: Ligne directrice : renouvellement de l'homologation d'un matériel médical et frais à payer pour le droit de vendre un instrument médical homologué. "November 18, 2013." Issued also in HTML format. |
| Publishing information | Ottawa, Ontario : Health Canada = Santé Canada, 2013. ©2013 |
| Description | 1 online resource (iii, 13 pages) |
| Catalogue number |
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| Subject terms | Medical instruments and apparatus -- Government policy -- Canada. |