The Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) has been provisionally approved by the Quality Council of India (QCI) to operate as a certification body for the ICMED 9000 and ICMED 13485 certification schemes, marking a significant milestone in the realm of medical device quality assurance in India.
The ICMED 9000 certification integrates ISO 9001 standards with additional scheme-specific requirements, while the ICMED 13485 certification encompasses ISO 13485 standards along with supplementary criteria tailored to the medical device industry. This approval empowers IPC-MvPI to assess and certify the quality management systems of medical device manufacturers, ensuring adherence to rigorous quality benchmarks.
Dr. Rajeev Singh Raghuvanshi, CEO and head of Certification at IPC-MvPI, received official confirmation from QCI following an office assessment in January 2024 and a subsequent follow-up assessment in May 2024.
The provisional approval, effective from June 3, 2024, to June 2, 2025, is subject to specific conditions. IPC-MvPI is required to obtain accreditation for ISO 13485 and include the scope sector IAF 19 (DL 33.1) in their existing Quality Management System (QMS) scheme as per ISO/IEC 17021 from the National Accreditation Board for Certification Bodies (NABCB) within one year. Failure to meet these requirements may result in suspension or withdrawal of QCI Scheme approval.
Additionally, IPC-MvPI must adhere to all applicable QCI-PADD website guidelines, including fee structures and data transparency obligations to maintain real-time applicant data publicly accessible.
The provisional grant encompasses certification for various categories of medical devices such as non-active medical devices (general non-active, non-implantable, non-active implants, wound care devices, and non-active dental devices), in vitro diagnostic medical devices (reagents, calibrators, control materials), and sterilization methods (ethylene oxide gas sterilization, moist heat sterilization).
This accreditation is a pivotal advancement towards elevating the standard of medical devices across India. By enforcing stringent quality protocols, IPC-MvPI aims to enhance consumer safety and bolster confidence in the reliability of medical devices available in the market.
With this provisional approval, IPC-MvPI is poised to play a crucial role in fortifying the regulatory framework and promoting a culture of excellence and safety within India’s medical device industry.