The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, Government of India, has officially notified KIHT Certification Services (KCS) as Andhra Pradesh’s first authorised regulatory body for inspecting manufacturing facilities producing Class A and Class B medical devices.
This development marks the establishment of the first CDSCO-notified body in both Andhra Pradesh and Telangana, out of the 14 currently operating across India. With this designation, KCS is now authorised to conduct regulatory audits under the Medical Devices Rules (MDR), 2017, reinforcing the region’s role in India’s expanding medical technology sector.
KCS was established in April 2022 and is accredited by the National Accreditation Board for Certification Bodies (NABCB) under ISO/IEC 17021‑1:2015 and IAF MD 9:2023 standards. The organisation provides services including ISO 13485 certification, quality system audits, risk management training, and CE-mark consultancy.
The notification is expected to directly benefit domestic manufacturers, especially micro, small and medium enterprises (MSMEs), by allowing them to complete audits locally. This eliminates the need for out-of-state inspections, reducing logistical costs and accelerating compliance processes.
KCS is a wholly owned entity of the Kalam Institute of Health Technology (KIHT), which was established in July 2017. KIHT is a Government of India initiative, supported by the Department of Biotechnology and located within the Andhra Pradesh MedTech Zone (AMTZ) campus. Its core mission includes supporting medical technology innovation through research, policy development, industry promotion, and knowledge management.
This development also supports broader national initiatives like “Make in India” and the “Atmanirbhar Bharat” manufacturing campaign.