BY THE DIGITAL HEALTH LEADERS FOR THE DIGITAL HEALTH COMMUNITY
BY THE DIGITAL HEALTH LEADERS 
CDSCO Releases Draft Guidelines on Medical Device Software; MTaI Seeks AI/ML Evaluation Clarity October 23, 2025 CDSCO releases 76-page draft guidance on medical device software licensing, standards, and evaluation; MTaI urges clarity on AI/ML-based device protocols.
CDSCO Streamlines Online Import Approval for Already Licensed Medical Devices & IVDs September 19, 2025 CDSCO has added a provision for subsequent importers of licensed medical devices and IVDs, streamlined brand approvals, and shifted most operations online to improve efficiency and transparency.
Healthtech Startup Dectrocel Secures Funding to Expand AI Diagnostic Platform DecXpert September 6, 2025 Dectrocel raises ₹4 Cr led by BioAngels to scale its AI diagnostic platform DecXpert in India, expand into Southeast Asia, and add new imaging modules.
Butterfly Learnings Launches India’s First CDSCO-Approved Autism Screening System September 4, 2025 Butterfly Learnings has launched Get SET Early, an autism screening system for children aged one to four years. The startup says it is the first such tool in India to receive regulatory approval from the Central Drugs Standard Control Organisation (CDSCO)
TDB Backs IIT-Guwahati-based Primary Healthtech’s AI-Powered Mobilab Blood Testing Device August 19, 2025 TDB has signed an agreement with Primary Healthtech to back Mobilab, an AI-powered, IoT-enabled portable blood testing device developed by IIT Guwahati alumni.
CDSCO Releases Revised Risk Classification List for Cardiovascular Devices April 4, 2025 The CDSCO has issued a revised risk classification list for 553 cardiovascular and neurological devices under the Medical Device Rules, 2017. Industry stakeholders are invited to submit feedback by April 30.
Alcon Unveils India’s First Fully Personalized LASIK Treatment with CDSCO Approval April 4, 2025 Alcon introduces Wavelight Plus, India's first fully personalized LASIK treatment, approved by CDSCO and the FDA. This offers precision vision correction using Ray Tracing Technology.
CDSCO Launches Online Portal for MSMEs to Seek Extension on Revised Schedule M Implementation March 25, 2025 Following the Health Ministry's latest notification, the CDSCO has introduced an online application system for MSME pharma units to request an extension on Revised Schedule M implementation.
CDSCO Launches Online Registration for Clinical Research Organizations March 6, 2025 CDSCO has launched an online registration portal for clinical research organizations (CROs). Registration is mandatory starting April 1, 2025, and applications must be submitted through the Sugam portal.
CDSCO Launches Online Portal for GMP Certificate Issuance & Verification March 3, 2025 CDSCO to introduce an online system for WHO GMP certification, streamlining verification and reducing delays in global pharmaceutical registrations.
CDSCO Moves Clinical Trial Applications to Online Portal January 3, 2025 CDSCO has transitioned the clinical trial site addition and change of principal investigator application process to the Sugam portal. The move aims to streamline the submission procedure for clinical trials in India.
SSI Mantra Becomes First CDSCO Certified Robotic System for Telesurgery in India December 10, 2024 SS Innovations’ SSI Mantra becomes the first surgical robotic system in India to receive CDSCO approval for telesurgery and teleproctoring, revolutionising access to advanced healthcare.
