MHRA, U.K. Road Map and Swiss Regulatory Updates
Our Emergo by UL expert outlines U.K. MHRA and Switzerland medical device regulatory updates in this on-demand webinar.
US FDA and Health Canada Launch eSTAR Pilot
The US FDA and Health Canada have announced the launch of their joint eSTAR pilot program, an interactive medical device submission form.
US FDA Issues Final Rule to Streamline Radiological Health Regulations
The US FDA issued a final rule to streamline the radiological health regulations and clarify certain provisions.
Canada Update: Proposed Amendments to Regulations on Licensing Drugs and Medical Devices
Health Canada is proposing amendments to regulations on licensing drugs and medical devices. Also, Health Canada published its annual adjustment of fees for the fiscal year 2023-2024.
KSA Update: New Guidance on Saudi Medical Device Classification and More
The Kingdom of Saudi Arabia (KSA) has introduced new guidance on medical device classification as well as other updates including guidelines for the use of radiation-emitting medical devices.
European Regulators Clarify Standard Fees for MDR, IVDR
The European Medical Device Coordination Group (MDCG) has issued new guidance on standard fees for the MDR and IVDR.
Medical Device and IVD Registration and Approval in Thailand
Medical device and IVD registration with the Thai Food and Drug Administration (FDA). Get our local support for approval.
Asia Resource Center for Medical Device and IVD Manufacturers
Emergo by UL helps medical device and IVD manufacturers expand their commercial reach to Asian markets with regulatory affairs expertise and local support services.
Japan Update: Notifications on Used Medical Device Sales; Simplification of Procedures for Online Applications; and More
Japanese regulators issued regulations on used medical device sales; simplification of online applications procedure, and more.
What's in Store for the EU Medical Device and IVD Sectors in 2023?
Key issues regarding European MDR and IVDR compliance and implementation heading into 2023