Andhra Pradesh has achieved a significant milestone by becoming the first state in India to host a CDSCO-notified auditing body for medical device manufacturing inspections. The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, Government of India, has officially recognized KIHT Certification Services (KCS) as the state’s first regulatory body authorized to inspect manufacturing facilities for Class A and Class B medical devices.
KCS is one of only 14 CDSCO-notified bodies in India, and it is the sole operational body in both Andhra Pradesh and Telangana. This recognition marks a crucial step forward in enhancing the region’s quality control capabilities in medical device manufacturing.
Established in July 2017, the Kalam Institute of Health Technology (KIHT), located within the AMTZ campus, is a government-backed initiative designed to foster innovation in medical technology. KIHT supports research, development, and industry growth, alongside contributing to policy-making and maintaining a knowledge repository. KCS, founded in April 2022, operates under KIHT and is accredited by the National Accreditation Board for Certification Bodies (NABCB) according to ISO/IEC 17021-1:2015 and IAF MD 9:2023 standards.
KCS provides a wide range of services, including ISO 13485 certification, quality system audits, risk management training, and CE mark consultancy. As a comprehensive service provider, KCS helps manufacturers align with global regulatory standards.
The approval of KCS as a notified body brings immediate advantages to domestic medical device manufacturers, particularly MSMEs, by eliminating the need for audits outside the state. This results in significant savings in both time and costs. Furthermore, the recognition strengthens Andhra Pradesh’s position as a leader in the MedTech industry, contributing to national initiatives such as “Make in India” and “ACI manufacturing,” while positioning the state as a prime location for future investments.
With this new certification authority, KCS is now empowered to conduct independent audits of Class A (low risk) and Class B (moderate risk) medical device manufacturers in compliance with the Medical Devices Rules (MDR) 2017. This move solidifies Andhra Pradesh’s reputation as a business-friendly hub and helps the state meet the growing global demand for high-quality healthcare products.
