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Transasia awarded India’s first ICMED quality certificate for IVD industry

Transasia Bio-Medicals Ltd. has received ICMED 13485 – Indian Certification for Medical Devices (ICMED) certification scheme. The company has been audited and registered by UL India Private Limited. With this accreditation, Transasia becomes the first in the IVD segment to receive this certification. Transasia received the ICMED 13485 certification for its manufacturing facilities at Mumbai, Daman, and Baddi. All the three facilities were successfully audited for quality compliance for the design, development, manufacture, installation, and service of IVD analyzers and reagents used in diagnosis.

ICMED is the country’s first indigenous quality assurance system for Indian manufactured medical devices. It is an initiative of Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). ICMED is aimed at enhancing patient safety, by providing the product credentials to manufacturers and is intended to significantly eliminate trading of sub-standard products or devices. The Indian medical device industry has long needed its own quality assessment system. The joint efforts of QCI and NABCB in making ICMED 13485 a reality will push forward IVD manufacturers, as it will bring down the substantial time and monetary investment to obtain globally accepted quality certifications. It will also give a boost to the Make in India focus on this industry. From the customer’s perspective, it will help in assuring standardized products.

For over three decades, Transasia has been delivering the highest quality of IVD instruments and reagents, not just in India but also globally. Transasia provides reliable, affordable and innovative medical diagnostic systems to over 35,000 customers and has an impressive install base of above 65,000 equipment in over 100 countries. Over the years, Transasia has been successfully certified as compliant and adherent to all international regulatory norms, and has well established documentation and procedures.   

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