The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic ...

IVDs are essential for disease detection, personalized treatment, and public health, driving growth in the global diagnostics ...

HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a consultation period calling on the public and private bodies for input as it looks to make changes across four key ...

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to ...

Roche Diagnostics is the first manufacturer to score certification for a class D product under the new in vitro diagnostic regulation (IVDR). TÜV SÜD Product Service issued the IVDR certificate. TÜV ...

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) ...

DUBLIN--(BUSINESS WIRE)--The "Middle East Medical Device Market by Product (In Vitro Diagnostics (IVD), Cardiology, Orthopedics), by FDA classification (Class I, II, III), by End-user, by Region and ...