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.
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.