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Visakhapatnam, July 6, 2025 — Andhra Pradesh has marked a significant milestone in the medical technology sector with the launch of its first Central Drugs Standard Control Organisation (CDSCO)-notified auditing body for medical device manufacturing. KIHT Certification Services (KCS), located within the Andhra Pradesh MedTech Zone (AMTZ) campus in Visakhapatnam, has been formally authorized to inspect and audit manufacturing facilities producing Class A and Class B medical devices.
KCS is now the only operational CDSCO-notified auditing body in Andhra Pradesh and Telangana, joining a select group of 14 such bodies across India. This development is expected to strengthen the region’s quality management capabilities and streamline regulatory compliance for medical device manufacturers, especially Micro, Small, and Medium Enterprises (MSMEs).
Established in April 2022, KCS operates under the aegis of the Kalam Institute of Health Technology (KIHT), a Government of India project founded in 2017 and supported by the Department of Biotechnology. KIHT plays a key role in promoting innovation, policy advocacy, and industry collaboration in the medical technology sector.
KCS holds accreditation from the National Accreditation Board for Certification Bodies (NABCB) and offers a comprehensive suite of services, including ISO 13485 certification, quality system audits, risk management training, and CE-mark consultancy. The presence of a local auditing body is anticipated to bring immediate benefits to domestic manufacturers by eliminating the need for out-of-state audits, resulting in significant time and cost savings.
Officials at the Andhra MedTech Zone emphasized that this accreditation reinforces Andhra Pradesh’s commitment to advancing its MedTech ecosystem and aligns with national priorities for healthcare innovation and quality assurance.
Disclaimer: This article is based on publicly available information as of July 6, 2025. For the latest updates or regulatory details, readers are advised to consult official government sources or the Central Drugs Standard Control Organisation.
