Public consultation: WHO Guidance on reportable changes to PQ-ed and EUL-ed IVDs
WHO is seeking for public comments on a new proposed version of the Guidance on reportable changes to IVDs. Manufacturers and other interested stakeholders are invited to share comments on the proposed draft guidance by 15 November 2024. The updated procedure for assessment of changes to IVDs will be implemented as of Q1 2024.
Regulatory Affairs Specialist | Biomedical Scientist | Ensure Compliance with Applicable Regulations for Timely Approval, Commercialization And access to In Vitro Diagnostics Medical Devices in resource limited areas.
4 个月Irena Prat please do you mean the new guidance document will be implemented in Q1 2025.
Technical Officer at World Health Organization
4 个月An essential resource for ensuring that prequalified IVDs continue to meet safety, quality, and performance standards after changes are implemented. This guidance helps manufacturers understand post-prequalification requirements, facilitating compliance and enhancing the quality of submissions.
Business Development I Regulatory operations I eCTD Submissions-RIMS-IDMP-CTIS
4 个月That's great seeing you are working while you are in India attending ICDRA...