Get Health Canada Medical Device Licence (MDL)
Medical devices have an indispensable role in the healthcare industry. They need to be strictly monitored and regulated for safety, efficacy, and quality to deliver high quality healthcare to patients. Their regulation plays a vital role in safeguarding the healthcare...
How to Easily Register Medical Devices in Canada? Your Guide
The Canadian medical device industry is evolving and dynamic with considerable growth potential. Entrepreneurs are showing growing interest to enter the Canadian medical device market. We have prepared this guide to help you easily register medical devices in Canada....
Regulations for Class I Medical Devices in Canada
Canada has well-balanced and strict regulations for medical devices entering its market. Health Canada regulates all medical devices in the Canadian medical device market. Health Canada’s medical devices regulations establish a comprehensive regulatory framework for...
What is the difference between US FDA 510(k) and PMA? A Guide
All medical devices entering the US market must comply with the regulatory requirements formulated by US FDA. These regulatory requirements are in place to ensure safe, effective, and high-quality medical devices reach the patients. The regulatory pathway required...