Global Medtech Guidance Tracker: February 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.
You may also be interested in...
FDA Updates Slew Of Radiology Guidance Documents
The US Food and Drug Administration has released revised versions of six guidance documents to reflect new x-ray reporting requirements, among other changes.
When Is An IVD A CDx? EU IVDR Guidance Updated To Include Flowchart
The EU Medical Device Coordination Group has issued a second revision to its guidance document on classification rules for in vitro diagnostics under the new regulation. The addition of a flowchart to determine when an IVD is a companion diagnostic is one key change.
Global Regulators Outline Quality Expectations For Cell And Gene Therapy Raw Materials
The International Pharmaceutical Regulators Programme explains how manufacturers of cell and gene therapy products can assess and mitigate the potential risks associated with product raw materials.