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...
10 Tips for Outsourcing Regulatory Affairs Team
Outsourcing is becoming increasingly common in pharmaceutical, medical device, and biotechnology, industries, especially in regulatory affairs and pharmacovigilance domains. Large and small companies alike are now turning to outsourcing vendors to manage...