In a significant boost to India's MedTech sector, Andhra Pradesh has launched its first-ever Central Drugs Standard Control Organisation (CDSCO)-notified body to audit medical device manufacturers.
KIHT Certification Services (KCS), operating under the Kalam Institute of Health Technology (KIHT), has been formally approved to conduct regulatory audits for Class A and Class B medical device manufacturing units. With this approval, KCS becomes one of only 14 notified bodies in India and the sole operational entity serving Andhra Pradesh and Telangana.
Headquartered at the Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam, KIHT was established in 2017 with support from the Department of Biotechnology. The institute plays a key role in advancing medical technologies through research, policy support, and collaboration with industry stakeholders.
KCS, which began operations in April 2022, is accredited by the National Accreditation Board for Certification Bodies (NABCB) and conforms to international standards including ISO/IEC 17021-1:2015 and IAF MD 9:2023. Its services include ISO 13485 certification, quality management system audits, risk management training, and consultancy for CE marking compliance.
Officials at AMTZ noted that the presence of a local auditing body will significantly streamline regulatory approvals for regional medical device manufacturers—particularly MSMEs—by reducing reliance on out-of-state audits and expediting compliance timelines.
This development marks a major step forward in positioning Andhra Pradesh as a key hub in India’s rapidly growing medical technology ecosystem.