Andhra Pradesh has achieved a significant regulatory milestone with the establishment of its first Central Drugs Standard Control Organisation (CDSCO)-notified auditing body for medical devices. KIHT Certification Services (KCS) has been formally authorized by CDSCO, under the Ministry of Health and Family Welfare, to conduct regulatory inspections of Class A and Class B medical device manufacturing facilities.
Strategic Positioning in Regional Healthcare Infrastructure
KCS stands as the only operational notified body among 14 such organizations nationwide currently serving Andhra Pradesh and Telangana. This designation marks a major advancement in the region's quality management capabilities and regulatory infrastructure for medical device manufacturing.
The certification body operates under the Kalam Institute of Health Technology (KIHT), which was founded in July 2017 as a Government of India project supported by the Department of Biotechnology. KIHT is strategically housed within the Andhra Pradesh MedTech Zone (AMTZ) campus in Visakhapatnam, where it promotes and supports innovations in medical technologies through research and development, industry promotion, policymaking, and knowledge management.
Comprehensive Regulatory Services Portfolio
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 organization provides a full spectrum of regulatory services designed to help manufacturers meet global standards, including ISO 13485 certification, quality management system audits, risk management training, and CE-mark consultancy.
This comprehensive service offering positions KCS as a complete regulatory solution hub for medical device manufacturers seeking to achieve compliance with both domestic and international standards.
Economic Impact on Manufacturing Sector
The establishment of KCS brings immediate operational benefits to domestic manufacturers, particularly micro, small, and medium enterprises (MSMEs) in the medical device sector. By providing local auditing services, the organization eliminates the previous requirement for manufacturers to seek audits outside the state, resulting in significant reductions in both time and costs associated with regulatory compliance.
Officials at the Andhra MedTech Zone have noted that this accreditation reinforces the state's commitment to advancing its MedTech ecosystem while aligning with national healthcare priorities. The local availability of auditing services is expected to facilitate more timely regulatory compliance audits and reduce logistical challenges for regional manufacturers.
Strengthening Regional MedTech Ecosystem
The CDSCO notification of KCS represents a strategic enhancement of Andhra Pradesh's position in India's medical technology landscape. By housing the state's first notified auditing body within the AMTZ campus, the initiative creates a concentrated hub of regulatory expertise that can support the growth and development of the regional medical device manufacturing sector.
This development aligns with broader national efforts to strengthen domestic medical device manufacturing capabilities and reduce dependence on imported medical technologies while ensuring adherence to stringent quality and safety standards.
