Subsequent to Gujarat government signing an MoU with HLL, a subsidiary under Union health ministry, the latter has initiated the process of procurement of testing equipment to facilitate setting up a medical device testing lab at Vadodara for the first time in the country.
Since there is no dedicated medical device testing lab in the country, the country today lacks in registering and thereby reporting adverse events due to faulty medical devices at the point of care.
Medical device testing lab at Vadodara in Gujarat would be the first and the only dedicated biomaterials and implants testing lab in the country. The testing lab will be housed at Gujarat FDCA office located strategically in the middle of a thriving industrial belt.
Says Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr H G Koshia, “The commerce ministry has sanctioned an amount of Rs. 15 crore for the manpower and lab infrastructure for setting up a dedicated testing lab exclusively for medical devices, and HLL is also in the final stages of procuring testing equipment on the same.”
In order to comply with all safety requirements, set of universal standards and norms have been prescribed, compliance to which ensures delivery of right technology in the right way. A means to verify the devices against this desired compliance is testing.
Setting up of a dedicated medical device testing lab in the country would be a boon for the Indian manufacturers to help adhere to compliance towards patient safety.
Apart from procurement of equipment, the lab will further develop in partnership with Union health ministry with technical support from Healthcare Technology Division of National Health Systems Resource Centre (NHSRC).
The idea of setting up the lab was mooted at an Engineering Export Promotion Council (EEPC) meet at Ahmedabad some time ago to ensure quality assurance of medical devices manufactured in the country.
Medical devices are usually sent to foreign countries for testing due to lack of a reliable and advanced medical device testing facility in the country. Few testing labs in the country which claim to offer testing are obsolete and not up to the mark, as per a survey done by NHSRC officials.
The government plans to set up two medical device testing labs in the country at Vadodara in Gujarat and another at Noida. The lab at Noida will be set up primarily to test electrical and electronic medical devices in
the country.