CDSCO releases revised list of Medical Device Testing Labs, Details
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has released the updated list of Medical Devices Testing Laboratories (MDTL), approving ten more MDTL to carry out tests or evaluation of medical devices on behalf of manufacturer registered with CDSCO under MDR 2017.
The updated list of medical devices testing laboratories (MDTL) was created in accordance with the Medical Devices Rules 2017, which were published under the Drugs and Cosmetics Act via GS R 78 (E) dated 31.01.2017 to regulate the manufacture, importation, sale, and distribution of medical devices.
Medical Dialogues Team had earlier reported that CDSCO had given its approval to medical devices testing laboratory (MDTL), including SIPRA LABS LIMITED, Star Imaging & Path Lab, Alcatec Research Laboratories India, and Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) for carrying out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under Medical Devices Rules 2017.
The updated list of medical devices testing laboratories registered with CDSCO up till under rule 81 in the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a medical device on behalf of the manufacturer reads,
To view the official notice, click the link below: