The Thiruvananathapuram-based Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), has been approved as a Medical Device Testing Laboratory for carrying out tests or evaluation of medical devices, on behalf of manufacturers, under the Medical Devices Rules, 2017.
This was approved by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Union Ministry of Health & Family Welfare. The approval for this registration is subject to the conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017.
India’s medical devices market is expected to grow over the coming years due to the increased healthcare awareness and government’s other healthcare initiatives. Medical device regulations in India was lacking prior to 2005. The Indian authorities overhauled the medical device regulatory process in 2017 and the rules came into force in January 2018 and are regulated by the CDSCO.
Medical devices, under the new rules, classified as per the Global Harmonization Task Force (GHTF) practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements, which have been specified in the rules and are based on best international practices.
Over the past two decades, SCTIMST has emerged as a pioneer in performing the testing and evaluation of medical devices and is certified by an international agency COFRAC, France. The CDSCO, New Delhi, has given approval to SCTIMST to conduct the Biological Evaluation of medical devices; such as cardio vascular devices, neuroprosthesis, orthopedic implants, dental implants and all other medical devices and materials as per ISO 10993.
This is another milestone in the history of SCTIMST. This approval is in continuation of an inspection conducted by CDSCO during 17-18 July 2019.