Category: Medical Device

Medical Devices-USA/Europe Regulatory News-October 2023

October 5, 2023
Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with preparation...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-Asia and ROW Regulatory News-Sep. 2023

September 25, 2023
Medical Device

ASIA INDIA (CDSCO) India puts regulations that facilitate R&D at heart of new policy on pharma and medtech India’s Department of Pharmaceuticals (DoP) has released the National Policy...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, Software Based Medical Devices

USFDA Latest Fee Summary Table for Drugs and Devices

September 13, 2023
Medical Device

Prescription Drug User Fee Amendments FY 2023 and FY 2024 User Fee Rates Fee CategoryFee Rates for FY 2023Fee Rates for FY 2024Application Requiring clinical data$3,242,026$4,048,695 ...

Application Fee, Facility Fee, GDUFA, MDUFA, PDUFA, USFDA

Medical Devices–Asia Regulatory Updates Roundup, Aug 2022

September 7, 2023
Medical Device

INDIA (CDSCO) List of Notified Bodies registered with CDSCO under MDR, 2017 CDSCO has published list of Notified Bodies registered with CDSCO under MDR 2017. Medical Device Rules 2017 has...

Medical Devices-USA/Europe Regulatory News-September 2023

September 6, 2023
Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance

Medical Devices-USA/Europe Regulatory News – August 2023

August 3, 2023
Medical Device

USA (FDA) Medical Device User Fee Rates for Fiscal Year 2024 The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees...

Europe Regulatory News, Harmonised standards, Medical Devices, Regulatory News, Software as a Medical Device (SaMD), USA Regulatory News