State gets CDSCO-notified medical device audit body
In a significant move, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has notified
KIHT Certification Services
(KCS) as the state's first regulatory body authorised to inspect manufacturing facilities for
Class A and Class B medical devices
.
Among 14 such notified bodies nationwide, KCS is the only one currently operational in Andhra Pradesh and Telangana, marking a major milestone in the region's quality management capabilities.
Founded in July 2017, the
Kalam Institute of Health Technology
(KIHT)-housed inside the AMTZ campus-is a Government of India project supported by the Department of Biotechnology. It promotes and supports innovations in medical technologies through research and development, industry promotion, policymaking, and knowledge management.
Established in April 2022, KCS is accredited by the National Accreditation Board for Certification Bodies and offers comprehensive services including
ISO 13485 certification
, quality systems audits, risk management training, and CE-mark consultancy-making it a full-service hub for manufacturers seeking to meet global regulatory standards.
This approval brings immediate benefits to domestic manufacturers, particularly MSMEs, by eliminating the need for audits outside the state-resulting in significant time and cost savings.
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