Indian Certification for Medical Devices (ICMED) 13485 Scheme
UL is a Certification Body under ICMED
Regulation of medical devices and their quality systems in India has been limited when compared to other developed nations that typically have very robust medical device approval systems in place.
To help address this gap, 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) established a voluntary quality certification scheme for medical devices in India, ICMED 13485.
The program is based on the international harmonized quality management system standards with additional requirements specific to the India market.
- ICMED 13485 – Based on the International Harmonized Standard (ISO 13485) “Quality Management Systems for Medical Devices” plus additional requirements specified under the scheme.
- ICMED 9000 – Based on the International Harmonized Standard (ISO 9000:2008), “Quality Management Systems.”
Who can apply?
- Indian medical device manufactures/ exporters
- Local authorized representatives of medical device manufactures/ distributors
Benefits of ICMED ISO 13485 registration
- Establish brand confidence of medical devices manufactured in India
- Enhance patient safety
- Provide healthcare users with quality medical devices manufactured in a certified facility
Upon successful completion of the program, UL will issue a certificate and add your company name to a public accessible database so that your customers and distributors can verify.
UL in India
UL started in India as a small Quality Registrations Services office with a handful of auditors in 1997, and today grown into a massive safety enterprise employing 600 professionals, serving a customer base of over 3,500 clients.. The humble 1,500 sq. ft. laboratory at Bengaluru striving to establish the science of safety has expanded into two state-of-the-art laboratories spanning 120,000 sq. ft. in Gurugram and Bengaluru. Two decades ago, our engineers were primarily testing only low voltage products. Today, complex products ranging from solar panels, mobiles phones, medical devices, LED and OLED televisions, short circuit boards, softlines, hardlines to toys undergo rigorous testing and certification in our facilities in India.
Our work in India is now aligned with the country’s urgent need for a robust quality ecosystem that will catapult ‘Brand India’ to the global stage. With mandatory in-country testing, the government needs sound support in enabling foreign manufacturers to enter the Indian market. Simultaneously, the success of domestic manufacturers capturing newer markets abroad is dependent on their complaince with international regulatory mechanism.
We help manufacturers in overcoming these crucial constraints with our profound understanding and experience in India’s regulatory climate, our expertise and presence in 140 countries. We aim to power the vision of ‘New India’ through our tailor-made services to build a safety ecosystem that will propagate an equilibrium between innovation and safety.
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