An Overview of Medical Device Classes in Canada
By: By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email Introduction In Canada, the intended use of a medical device primarily determines its class. Classification must be consistent with [...]
Medical Devices Canada | Regulatory Overview
By: By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email Introduction to Medical Devices in Canada Medical devices are defined in the Food and Drugs Act as health or medical instruments used for [...]
The Ultimate Guide to Medical Device Quality Assurance: Understanding Quality Assurance Processes in Canada
By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email What is Medical Device Quality Assurance? Medical devices in Canada encompass a broad spectrum of instruments utilized in the [...]
Medical Device Licensing: Annual Renewals Are Around the Corner
By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email In the realm of medical device safety, effectiveness, and quality, Canada has some of the strictest regulatory requirements. One of the key [...]
Medical Device Regulations Amended: SOR/2024-136
By: Jan Noupbaev, ASSOCIATE DELL TECH LABORATORIES Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product [...]
Medtech Canada 2024 and Dell Tech’s Medical Device Regulatory & Quality Services
By: Steve McCarthy, DIRECTOR OF REGULATORY AFFAIRS, email Dell Tech attended the Medtech Canada 2024 Regulatory & Quality conference in Ottawa at the end of April. This hybrid event marked [...]
English