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 ...

Third on the agenda, the MHRA is turning its attention to the regulation of In Vitro Diagnostic (IVD) devices, seeking views on the regulatory requirements for Class B IVD devices to gain market ...

IVD, Orthopedic & Dental, Opthalmic, Vascular), Class, Testing, Region) - Global Forecast to 2025", published by MarketsandMarkets™, the Medical Device Testing Market was valued at USD 9.3 ...

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) ...

but would require that devices meet new UDI requirements, including bearing a UDI on the device and labels. IVDs: The MHRA has proposed replacing the current classification scheme with one better ...

Premaitha Health plc has announced that it has met two key requirements for obtaining a CE-mark for its IONA® test: ISO 13485:2003 certification and a successful audit of Annex IV of the In Vitro ...

Typically, in the UK, IVD Devices are classified in one of four categories. Class B is the default class that takes in all IVD devices that are not covered specifically in other classification rules.