Medical devices are different from drugs, therefore cannot be treated as drugs in long run
Medical Technology Association of India (MTaI), represents research-based medical technology companies in manufacturing, R&D and healthcare training in India, said that while the overall decision of the DTAB to bring more devices under regulation is a welcome step its implementation needs exhaustive consideration.
“First, an exhaustive analysis of the un-notified part of the device universe is required. Some of these products could be critical and life-saving, but sold in tiny quantities. CDSCO could look at revising downwards the registration fees so that the market stays attractive to these small but vital operators. Also, a game plan should be ready to make up for their likely departure for reasons of viability. To handle the additional workload, CDSCO should assess whether the manpower mandated by DTAB is available to regulate the new devices expeditiously”, said Pavan Choudary, Chairman, MTaI.
The association said the decision to bring more devices under regulation is welcome as it would strengthen patient safety, but the government should also prioritise creation of separate law for medical devices. “Medical devices are generically different from drugs and therefore cannot be treated as drugs in the long run. The government should expedite the deliberations on institutionalising a suitable and exclusive legal framework for medical devices so that areas of quality, adverse events, compensation, prices, healthcare training, Health Technology Assessment, et. al. are comprehensively addressed,” said Choudary.