2020-04-26: Proud moment for DiaSys India to receive Certification for Medical Devices (ICMED) 13485

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 (Indian Certification for Medical Devices- Quality Management systems for regulatory purposes based on the International Harmonized Standard ISO 13485)

DiaSys India has been awarded the certificate of ICMED 13485; Certificate Registration Number 9940000025, on 8th April 2020, for its Mahape, Navi Mumbai facility.

The audit was carried out by TUV SUD South Asia- the first certification body in India to be accredited by NABCB for certifying Medical Devices Organization under ISO 13485 and ICMED Scheme. TUV SUD South Asia awarded this certificate to DiaSys India under the scope of “Manufacturing & Distribution of In-Vitro Diagnostic Products (Biochemistry & Hematology Reagents, Rapid Test Strips and Analyzers).

DiaSys India is one among the only five IVD companies in India today to be certified for the ICMED 13485.

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.