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In order to ensure safety and efficacy of medical devices marketed in the country, the Union government plans to set up two medical device testing labs in the country at Vadodara in Gujarat and another at Noida based on the recent approval from the department of commerce. The medical device testing lab in Gujarat would be the first and the only dedicated biomaterials and implants testing lab in the country. The lab at Noida will be set up primarily to test electrical and electronic medical devices in the country.
Setting up of the dedicated medical device testing labs in the country would be a boon for the Indian manufacturers to help adhere to compliance towards patient safety as the country today lacks in registering and thereby reporting adverse events due to faulty medical devices at the point of care.
National Health Systems Resource Centre (NHSRC), a technical support institution under the ministry of health & family welfare, government of India had done a nation-wide survey of 16 testing labs in the country and surveyed 9 medical device testing labs across the globe. On the basis of the survey, a report was submitted to the government specifying the need and the modalities required for setting up a dedicated medical device testing lab based on the standards existing globally.
Such type of testing labs will allow manufacturers to overcome deficiencies in their products and enhance product value in the market which is a hitherto neglected aspect until now. Till date, products are usually sent to foreign countries for testing due to lack of a reliable and advanced medical device testing facility in the country. Only a few testing labs in the country which claim to offer testing have been found to be redundant and obsolete.
Work for the lab at Vadodara, Gujarat will start in the coming three months time for which building is available and will be housed at Gujarat Food and Drug Control Administration (FDCA) office located strategically in the middle of a thriving industrial belt. The lab is likely to be operational in the coming 6 months time following the celebrations of World Health Organisation (WHO) day on April 7, 2016.
In order to comply with all safety requirements, sets 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. Thus, product testing brings into existence the first level of assessment of appropriateness and safety of a device. This would complement the government's Make in India’ drive pushing industrial growth and encouraging medical devices sector in the country.
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