China Update: Announcement No. 124 of 2022; Draft Guidelines for the Registration of Implantable Medical Devices
Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries
EC Names Eighth Notified Body for IVDR
The European Commission (EC) has named QMD Services GmbH as the eighth Notified Body designated to the In Vitro Diagnostic Regulation (IVDR).
South Korea Updates: Innovative Device Designations, IVD Act Enforcement
Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for manufacturers.
Australia Update: Medical Device UDI Implementation, Essential Principles Guidelines
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance requirements and guidelines for active med
New European Guidelines on Notified Body Surveillance Obligations Under the IVDR
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance covering surveillance activities required of Notified Bodies under Article 110 of the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Israel Registration Holder for Device and IVD Companies
Emergo, with offices in Israel and worldwide, acts as an independent regulatory representative for medical device and IVD manufacturers.
Tom Ingless - United Kingdom
IVDR Update: European MDCG Issues Guidance on Substantial Modification of a Performance Study
An MDCG guidance document explains the process for obtaining permission to conduct a substantial modification of a performance study in European Union member states according to Regulation (EU) 2017/746.
Medical Device Regulatory Requirements - New Japanese Guidelines
In this complimentary webinar, we review the resources you’ll require and the steps you should take to complete your path to market in Japan.
The Future of Healthcare in the Metaverse
A look at how the metaverse may affect healthcare delivery and medical product development