Navigating the Current US FDA Medical Device Classification
For manufacturers looking to enter the US medical device market for the first time, the US FDA approach to…
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The Impact of the MDR 2023/607 on Medical Device Regulations
The Medical Device Regulations (2017/745) (“MDR”) called out a Date of Application of 26 May 2021, for which all Class…
FDA Final Rule to Amend Medical Device Quality System Management Regulation
The FDA published the Quality System Management Final Rule on January 31st. This rule amends the current device good manufacturing…
New EU MDCG Guidance on Medical Device Vigilance Requirements
A large release of the…
CDSCO Guidance: FAQs for Medical Device Registration in India
Registration of medical devices in India is regulated by the Central Drug Standard Control Organization (CDSCO) under…
MDR and IVDR Language Requirements Update
The European Commission, in collaboration with Member States, has introduced tables under the Medical Device Regulation (MDR) and…
EU MDR Risk Classification: Guide and Case Study
Manufacturers are responsible for determining…
MHRA’s Revised Medical Device Regulations Roadmap
On the 9th of January, the MHRA in the UK published an updated roadmap to regulation of medical devices in…
Swissmedic Provides Definition for In-House IVDs
Swissmedic has recently updated their FAQ that provides the definition for in-house IVDs, and examples of what is and…
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