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A Historic Milestone: AVI Healthcare Becomes India’s First ICMED 13485 Plus Certified Medical Device Manufacturer!
18, March 2025
We are honored and immensely proud to announce that AVI Healthcare has become the first medical device manufacturer in India to achieve the prestigious ICMED 13485 Plus Scheme Product Certification for four of its Devices, namely, Infant Warmers, Phototherapy units, Transport Incubators, Infant CPAP units!
This remarkable achievement marks a significant milestone in the Indian regulatory landscape and reinforces our unwavering commitment to quality, safety, and compliance.
For decades, we have upheld the highest global standards, holding a CE certification under MDD and now transitioning to full compliance with the EU MDR. The ICMED 13485 Plus certification adds yet another milestone to our journey, ensuring that our products meet international as well as national recognized quality benchmarks.
What is ICMED 13485 Plus?
The Indian Certification for Medical Devices (ICMED) 13485 Plus is India’s first indigenous Medical Device Product Certification Scheme, designed to bridge the regulatory gap in quality certification for medical devices. Developed by the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), this certification is on par with the CE marking in Europe, providing a robust framework for medical device quality and safety in India.
This accomplishment is a testament to our relentless pursuit of excellence, innovation, and regulatory leadership in the medical device industry.
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