The Central Drugs Standard Control Organization (CDSCO) on October 09, 2026, issued Draft Guidance document for Manufacturers of In-vitro diagnostic Medical device for stakeholders comment.
The document provides manufacturers with instructions for submitting product licence applications through the CDSCO Online (CDSCO MD Online) and National Single Window System (NSWS) portals.
The guidance specifies the information to be furnished in each section of the application in alignment with the relevant checklist to ensure completeness, accuracy and timely approval. Relevant stakeholders are invited to submit their comments and suggestions within 15 days from the date of publication through the Google Form – https://docs.google.com/forms/d/e/1FAIpQLSez2yrue7Vv58vf9FXq4vrKqK-kDs0BiZo68xBK7kSNiU3_-A/viewform
[Notification No. CDSCO/IVD/GD/DRAFT/MFG/01/2026]
