In a key development for the medical device industry, Andhra Pradesh now has its first Central Drugs Standard Control Organisation (CDSCO)-notified audit body for medical devices.
The CDSCO, functioning under the Ministry of Health and Family Welfare, has officially recognized KIHT Certification Services (KCS) as a regulatory authority to carry out inspections of manufacturing units producing Class A and Class B medical devices.
Out of the 14 such bodies recognized across India, KCS stands out as the sole operational entity in Andhra Pradesh and Telangana, representing a significant step forward in strengthening the region’s medical device quality assurance ecosystem.
KCS functions under the Kalam Institute of Health Technology (KIHT), a Government of India initiative supported by the Department of Biotechnology and located within the AMTZ campus. Since its inception in July 2017, KIHT has been working to promote innovation in medical technology by facilitating R&D, supporting industry growth, contributing to policy development, and managing sectoral knowledge.
KCS, established in April 2022, holds accreditation from the National Accreditation Board for Certification Bodies. It offers a wide range of services, including ISO 13485 certification, quality management system audits, risk management training, and CE-mark consulting, making it a one-stop destination for manufacturers aiming to comply with global regulatory norms.
This recognition is expected to directly benefit local manufacturers, especially small and medium enterprises (MSMEs), by enabling them to complete mandatory audits within the state. This eliminates the need for costly and time-consuming audits elsewhere, delivering both economic and logistical advantages.
