International Medical Device Regulators Forum (IMDRF) Progresses
At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force
New EU IVD Regulations, Potentially In Line with Australian IVD Requirements
The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be pote
China: Reduced Clinical Trial Requirements Ease Regulatory Burden
It has been reported by law firm Sidley Austin that a new rule has been issued by the Chinese State Food and Drug Administration (SFDA) which is designed to simplify clinical trial
New MEDDEV Documents Released
As of 1 July 2024, new regulatory requirements for medical devices containing medicinal substances, or materials derived from animal, microbial, or recombinant sources will take ef
Device Regulation Changes in Mexico
The Mexican healthcare product regulatory body, Cofepris, has been working to development and release new requirements and agreement for therapeutic goods in Mexico. The changes ar