VISAKHAPATNAM: Andhra Pradesh has received its first Central Drugs Standard Control Organisation (CDSCO)-notified auditing body for medical device manufacturing.
KIHT Certification Services (KCS) has been formally authorised to conduct regulatory audits for Class A and Class B medical device manufacturing units. KCS is among 14 such notified bodies in the country and the only one currently operational in AP and Telangana.
KIHT Certification Services operates under the aegis of the Kalam Institute of Health Technology (KIHT), founded in 2017 and based within the Andhra Pradesh MedTech Zone (AMTZ) campus in Visakhapatnam.
Supported by the Department of Biotechnology, KIHT fosters innovation and development in medical technology through research, policy advocacy, and close industry collaboration. Established in April 2022, KCS holds accreditation from the National Accreditation Board for Certification Bodies (NABCB) under ISO/IEC 17021-1:2015 and IAF MD 9:2023 standards.
The organisation offers a comprehensive range of services, including ISO 13485 certification, quality management system audits, risk management training, and CE-mark consultancy.
This local availability of auditing services is expected to benefit medical device manufacturers, particularly MSMEs, by facilitating timely regulatory compliance audits and reducing the need for out-of-state inspections.
Officials at the Andhra MedTech Zone noted that this accreditation reinforces AP’s commitment to advancing its MedTech ecosystem, aligning with national priorities.