Guidance Document - Guidance on the Risk-based Classification ... - Canada
Apr 23, 2015 · The safety and effectiveness evidence required to support a medical device licence application is proportional to the risk of the device, which is determined by applying the Classification Rules for Medical Devices detailed in Schedule 1 of the Regulations.
Medical devices - Canada.ca
Feb 22, 2023 · Resources related to and required for sale of medical devices in Canada including legislation, Health Canada guidelines, applications and submissions, fees, licences and quality system requirements.
About medical devices - Canada.ca
In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Class I medical devices (e.g., a thermometer) pose the lowest risk to users. Class IV medical devices (e.g., a pacemaker) pose the highest risk.
Understanding Health Canada's Medical Device Classification
Oct 21, 2024 · Health Canada administers the regulation of medical devices in Canada, including establishing a classification system for those devices based on their Explore Health Canada's medical device classification system, from Class I to IV, …
Guidance Document - Guidance on the Risk-based Classification …
Jun 12, 2015 · Return to figure - Active Devices. Description - Special Rules. Rule 13, Intended to be used to: Disinfect or sterilize blood, tissues or organs that are intended for transfusion or transplantation, IV, unless, disinfect or sterilize a medical device, II.
All medical devices sold in Canada must be safe and effective. This document is intended to provide guidance on the clinical evidence requirements for Class II, III and IV medical devices.
GUIDANCE DOCUMENT. How to Complete the Application for a New Medical Device Licence. Published by authority of the Minister of Health. Health Products and Food Branch. Our mission is to help the people of Canada maintain and improve their health. Health Canada.
Medical Devices Regulations ( SOR /98-282) - Site Web de la ...
Table of Contents. Medical Devices Regulations. 1 - Interpretation. 2 - Application. 6 - Classification of Medical Devices. 8 - PART 1 - General. 8 - Application. 9 - Manufacturer’s Obligations. 10 - Safety and Effectiveness Requirements.
Health Canada Medical Device Classification Service — …
We offer Health Canada device classification to help determine class for medical or surgical devices, IVD, POCT-NPT, or SaMD. Free initial consultation. Email: [email protected]. Phone: +1-905-910-0615.
Classification of health products at the drug-medical device ... - Canada
The Office of Science provides recommendations on the classification of products as either drugs (i.e., pharmaceutical, biologic, or natural health product), medical devices or drug-medical device combination products.