State gets CDSCO-notified medical device audit body
In a significant move, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has notified
KIHT Certification Services
(KCS) as the state's first regulatory body authorised to inspect manufacturing facilities for
Class A and Class B medical devices
.
Among 14 such notified bodies nationwide, KCS is the only one currently operational in Andhra Pradesh and Telangana, marking a major milestone in the region's quality management capabilities.
Founded in July 2017, the
Kalam Institute of Health Technology
(KIHT)-housed inside the AMTZ campus-is a Government of India project supported by the Department of Biotechnology. It promotes and supports innovations in medical technologies through research and development, industry promotion, policymaking, and knowledge management.
Established in April 2022, KCS is accredited by the National Accreditation Board for Certification Bodies and offers comprehensive services including
ISO 13485 certification
, quality systems audits, risk management training, and CE-mark consultancy-making it a full-service hub for manufacturers seeking to meet global regulatory standards.
This approval brings immediate benefits to domestic manufacturers, particularly MSMEs, by eliminating the need for audits outside the state-resulting in significant time and cost savings.
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The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has notified the Kalam Institute of Health Technology (KIHT) Certification Services (KCS) as the State's first regulatory body authorised to inspect the manufacturing facilities for Class A and Class B medical devices, according to a release here. Among the 14 such notified bodies nationwide, KCS is the only one operational in Andhra Pradesh and Telangana, marking a milestone in the region's quality management capabilities. Founded in July 2017, the KIHT, located on the AMTZ campus, is a Central government project supported by the Department of Biotechnology. It promotes and supports innovations in medical technologies through research and development, industry promotion, policy-making and knowledge repository. Founded in April 2022, the KCS is accredited by the National Accreditation Board for Certification Bodies (NABCB). The organisation offers comprehensive services, including ISO- 13485 certification, quality systems audit, risk management training, and CE‐mark consultancy — making it a full service hub for manufacturers seeking to meet global regulatory standards. This approval brings immediate benefits to domestic manufacturers, particularly the MSMEs, by eliminating the need for audits outside the State — resulting in significant time and cost savings. It also reinforces Andhra Pradesh's MedTech credentials, supporting national campaigns like 'Make in India' and 'ACI manufacturing', while making the region highly attractive for future investments. This significant milestone empowers KCS to conduct independent regulatory audits for medical device manufacturers in accordance with the Medical Devices Rules (MDR)-2017 for Class A (low risk) and Class B (moderate risk), the release added, while underscoring the State's reputation as a business-friendly hub, ready to meet rising global demand in healthcare.
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2 days ago
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State gets CDSCO-notified medical device audit body
Visakhapatnam: Andhra Pradesh is now home to its first-ever CDSCO-notified auditing body for medical devices. In a significant move, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has notified KIHT Certification Services (KCS) as the state's first regulatory body authorised to inspect manufacturing facilities for Class A and Class B medical devices . Among 14 such notified bodies nationwide, KCS is the only one currently operational in Andhra Pradesh and Telangana, marking a major milestone in the region's quality management capabilities. Founded in July 2017, the Kalam Institute of Health Technology (KIHT)-housed inside the AMTZ campus-is a Government of India project supported by the Department of Biotechnology. It promotes and supports innovations in medical technologies through research and development, industry promotion, policymaking, and knowledge management. Established in April 2022, KCS is accredited by the National Accreditation Board for Certification Bodies and offers comprehensive services including ISO 13485 certification , quality systems audits, risk management training, and CE-mark consultancy-making it a full-service hub for manufacturers seeking to meet global regulatory standards. This approval brings immediate benefits to domestic manufacturers, particularly MSMEs, by eliminating the need for audits outside the state-resulting in significant time and cost savings.
