Types of Medical Devices & Regulatory Classification Across Major Markets
Put a tongue depressor next to a pacemaker and the gap is obvious. Both count as medical devices, yet they’re […]
MedTech Insights
Stay updated with the latest in medical technology through MedTech Insights. Explore trends, innovations, news, and expert analysis on healthcare devices, digital health, diagnostics, and MedTech advancements.
Medical Device Regulations and Registration Process in Canada
Medical device registration Canada is not one process. Health Canada issues two separate licences. A medical device licence (MDL) covers
MDSAP Certification: Audit Process, Countries and Requirements
Medical device manufacturers often have to meet quality-system requirements in more than one country. Under MDSAP, they can undergo a
Medical Device Regulations and Registration Process in Switzerland
Expanding into the Swiss medical device market requires more than EU MDR or EU IVDR compliance. Manufacturers must also meet
Medical Device Regulations and Registration Process in the UAE
Medical Device Registration in UAE is now handled by Emirates Drug Establishment (EDE), making it the primary authority manufacturers and
South Korea Government Schemes for Pharma & Medical Devices
Most companies entering South Korea’s pharma or medical device space fail to fully utilize available government schemes simply because they
Medical Device Regulations and Registration Process In Japan
Japan is one of the most regulated healthcare markets globally, and medical device regulations in Japan reflect that. No medical
Global Medical Device Statistics, Facts & Trends 2026
There are an estimated 2 million different kinds of medical devices on the world market, grouped into more than 7,000
EU Authorized Representative (EAR) Role, Responsibilities & Appointment Process
Appointing an EU Authorized Representative is the most important step for IVD or medical device manufacturers established outside the European