Tag: CDSCO
MTaI welcomes CDSCO’s draft guidance on medical device software
The association commended CDSCO for its proactive step in framing a comprehensive regulatory framework for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)
AstraZeneca secures CDSCO approval for expanded use of Trastuzumab Deruxtecan in...
This marks the first and only antibody drug conjugate (ADC) in India with a tumour-agnostic indication, representing a significant advancement in precision oncology
AiMeD welcomes govt’s GST rate cut & MRP implementation relief for...
Recalling or re-labelling of existing stock already released in the market will not be mandatory
Roche partners 10 govt hospitals to strengthen clinical trial capabilities in...
Initiative aligns with CDSCO priorities to boost participation of government sites in Phase 3 and 4 Trials
ANVISA approves Concept Medical’s MagicTouch Sirolimus-Coated Balloon for CAD treatment
This milestone enables patients access across Brazil in Latin America, offering a new pathway for managing cardiovascular disease
Medtronic launches Evolut™ FX+ in India, advancing TAVI for Aortic Stenosis
Approved by CDSCO on June 10, 2025, the valve is designed for patients with severe aortic stenosis by improving coronary access
AliveCor launches groundbreaking AI-powered Kardia 12L ECG System in India
Kardia 12L, which has received Central Drugs Standard Control Organisation (CDSCO) approval for use in India, detects 35 cardiac determinations
Eyestem completes Phase 1 of its RPE Cell Therapy with promising...
Phase 2 of the trial will begin as soon as Eyestem receives approval from the CDSCO
Parexel completes CDSCO registration
The registration under the new G.S.R 581(E) regulation reflects Parexel’s commitment to regulatory compliance and clinical research excellence in India
CDSCO ensuring strict drug quality, withdrawal rules apply on non conforming...
In case of drug samples declared as Not of Standard Quality by the Drugs Testing laboratories under CDSCO, the respective manufacturing firms are asked for immediate recall and stop further distribution of the Not of standard quality drugs in the market