MEDICAL DEVICES : Regulatory News from around the world
Updates on developments in regulatory compliance requirements in overseas markets
USA : Medical Devices 101: Premarket Notification 510(k)
In this 3-part series, we explore the basic foundations of FDA’s regulation of Medical Devices. Topics include Controls and Classifications, Premarket Notification 510(k), and Premarket Approval (PMA).
INDIA : New Notification on Regulating All Devices – Deciphering the Key Concepts | CliniExperts
The CDSCO issued an important notification only for the medical devices which are currently falling under the non-regulated category. If you are an importer or manufacturer of medical device in India then from 1st April 2020 onwards all medical devices...
USA : FDA Requirements to Ship Face Masks to the USA | Registrar
To export masks to the USA, you first need to identify your product code. This is the determining factor for whether you need FDA clearance or NIOSH-Approval.
USA : FDA UDI Deadline Delayed for Class I Devices | Registrar
Registrar Corp compiled blogs, infographics, and videos on U.S. FDA Unique Device Identifier (UDI) requirements to help industry prepare.
USA : FDA Announces New Medical Device and Generic Drug User Fees for FY 2021 | Registrar
The U.S. Food and Drug Administration has announced the Fiscal Year 2021 fees under GDUFA and the MDUFA.