IPC-MvPI awarded provisional approval as certification body for ICMED 9000 and ICMED 13485

IPC-MvPI awarded provisional approval as certification body for ICMED 9000 and ICMED 13485

Posted on July 10, 2024 Updated on July 8, 2024

The Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) has received provisional approval from the Quality Council of India (QCI) to operate as a certification body for the ICMED 9000 and ICMED 13485 certification schemes.

The ICMED 9000 certification integrates ISO 9001 requirements with additional specifications unique to the scheme, while the ICMED 13485 certification encompasses ISO 13485 requirements along with supplementary scheme-specific criteria. This significant development allows IPC-MvPI to evaluate and certify the quality management systems of medical device manufacturers.

In an official communication addressed to Dr. Rajeev Singh Raghuvanshi, CEO and head of Certification at IPC-MvPI, the Quality Council of India (QCI) confirmed the provisional approval based on an office assessment conducted on January 10 to 11, 2024, and a follow-up assessment on May 11, 2024.

The approval is granted for one year, from June 3, 2024, to June 2, 2025, under the following conditions. Accreditation requirements stipulate that IPC-MvPI must 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 National Accreditation Board for Certification Bodies (NABCB) within one year. No further approval will be given under the QCI Scheme if this requirement is not met.

IPC-MvPI must comply with all applicable requirements, fee structures, and guidelines available on the QCI-PADD website. Data Transparency implies that the certification body must maintain real-time data of their applicants on a publicly available platform.

Failure to comply with any of these requirements may lead to suspension or withdrawal of the approval.

The provisional grant under the scope sectors as per the assessment includes non-active medical devices like general non-active, non-implantable medical devices, non-active implants, devices for wound care and non-active dental devices and accessories. In vitro diagnostic medical devices like reagents and reagent products, calibrators, and control materials. Sterilization methods for medical devices like ethylene oxide gas sterilization (EtO), moist heat sterilization.

This accreditation marks a crucial step in advancing the quality of medical devices in India. By ensuring that manufacturers adhere to stringent quality standards, IPC-MvPI aims to enhance consumer protection and bolster the overall reliability of medical devices available in the market.

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With this provisional approval, IPC-MvPI is set to play a pivotal role in strengthening the regulatory framework and fostering a culture of quality and safety within the Indian medical device industry.