Skip to main content
search
Category

Industry Newsletters Regulatory Affairs Newsletter Archive

Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI Standard PRE06 – Evaluation of External Transport Systems

Dear Members, CLSI have published a new standard for evaluation of external transport systems. This is a laboratory focused standard. PRE06 | Evaluation of External Transport Systems Abstract CLSI PRE06—Evaluation of External Transport Systems describes processes for evaluating an external transport system. Specimens are commonly transported from external, off-site locations to the laboratory, where they are eventually examined. The system…
Ben Kemp
March 5, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Your latest One IPO Patent Service update!

The One IPO Patent Service is launching on 31 March 2026. Here are the latest updates to keep our patent customers informed: What to expect when the One IPO Patent Service launches Today we have published an update on what our patent customers can expect as we approach the launch of the new service on 31 March. Find out more:…
Ben Kemp
March 5, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers

Dear Members, IMDRF have issued Industry guidance on the considerations for the selection of IMDRF Adverse Event Terminology  N86: Final 2026 It includes examples of which 8, 12 and 18 are specific to IVDs. Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers View article...
Ben Kemp
March 5, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Now Published: CLSI C65 | Biochemical Tumor Markers

New Publication! Strengthen Tumor Market Testing with CLSI C65   Biochemical tumor marker plays a critical role in diagnosis, monitoring, and clinical decision making. With increasing pressure on laboratories to ensure accuracy and consistency across preexamination, examination, and postexamination processes, the new CLSI C65 standard provides the guidance needed to reduce risk and improve confidence in patient results.   Practical…
Ben Kemp
March 2, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Use of legislative powers related to recalls and other market actions

Dear Members, TGA Australia have issued an update on use of legislative powers related to recalls and other market actions Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions. View article...
Ben Kemp
February 27, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO Position Note on Accessories

Dear Members, WHO has issued a Position Note on Accessories Position Note on Accessories Published | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) This provides guidance regarding accessories supplied with WHO Pre-Qualified Devices.
Ben Kemp
February 27, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NICE – Statement of intent – NICE’s approach ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds

Dear members, please see below update from NICE - Statement of intent - NICE's approach ongoing evaluations ahead of proposed changes to NICE's standard cost-effectiveness thresholds. Overview | Statement of intent on NICE’s approach to ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds | Guidance | NICE
Ben Kemp
February 27, 2026
Close Menu