UL India 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 publically accessible database so that your customers and distributors can verify.
UL has the third party accreditations, test capabilities and expertise to support your submission requirements for application to the major medical markets including the US, Canada, the European Union, Brazil, China, and beyond. As such, we can conduct your ICMED audit along with other quality system assessments to enable more streamlined access to global markets.
Our team of in-house auditors are experienced technical experts with education and experience working with Medical Devices, saving you time in explaining your products and adding value to see the real time benefits a robust quality system affords to your business.
As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.