Author: Bhavesh Patel, C. Chem.
The International Medical Device Regulators Forum (IMDRF) recently published a Proposed Guidance Document titled Definitions for Personalized Medical Devices (the “Guidance”). The Document is open for public consultation and has been posted on the IMDRF website for comments from the public.
The purpose of the Guidance is to harmonize definitions used to describe medical devices intended for a particular individual. The adoption of consistent, harmonized definitions for such medical devices could underpin a harmonized regulatory approach for controls on these devices and offer significant benefits to the manufacturer, user, patient, and to regulatory authorities. Eliminating differences between jurisdictions supports global convergence and decreases the cost of gaining regulatory compliance. The potential reduction in regulatory red tape will also allow patients to gain earlier access to new technologies and treatments.
This consultation will close on Thursday, May 24, 2018. The comment template can be find here.
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