A Historic Milestone: AVI Healthcare Becomes India’s First ICMED 13485 Plus Certified Medical Device Manufacturer!

18, March 2025

A Historic Milestone: AVI Healthcare Becomes India’s First ICMED 13485 Plus Certified Medical Device Manufacturer

AVI Healthcare is proud to announce a significant milestone in its quality journey by becoming India’s first medical device manufacturer to receive the ICMED 13485 Plus Product Certification for four product categories: Infant Warmers, LED Phototherapy Units, Transport Incubators, and Infant CPAP Units.

This achievement marks an important milestone for both AVI Healthcare and the Indian medical device industry, reaffirming our long-standing commitment to quality, patient safety, regulatory compliance, and manufacturing excellence.

For years, AVI Healthcare has maintained internationally recognised quality standards. Our products have been CE certified under the Medical Devices Directive (MDD), and we have continued strengthening our regulatory framework in line with the European Medical Device Regulation (EU MDR). Receiving the ICMED 13485 Plus Product Certification reflects AVI Healthcare’s continued investment in innovation, robust manufacturing processes, comprehensive quality management, and regulatory excellence.

As we continue to expand our portfolio of neonatal and critical care medical devices, this milestone strengthens our mission of delivering safe, reliable, and high-quality healthcare technologies to hospitals across India and international markets.

What is ICMED 13485 Plus Certification Scheme?

It is India’s indigenous medical device product certification scheme. It was 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) to promote quality, safety, and reliability in medical devices manufactured in India.

The certification provides an additional level of assurance by evaluating not only the manufacturer’s quality management system but also product-specific requirements, helping build confidence among healthcare providers, regulators, and patients.

Industry Recognition

This milestone received appreciation from leaders associated with India’s quality and medical device ecosystem. This was also shared by Mr. Anil Jauhri, former CEO of the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), recognising this important milestone for the Indian medical device industry.

You can also view posts shared by members of the AVI Healthcare team celebrating this achievement and its significance for indigenous medical device manufacturing.