A group in India is looking for more help from the US FDA. This is probably good news in light of a few recent stories. One area of particular interest is the Medical device area, something all of us have an interest in as software is now playing a very large role in how the devices work and will continue to work. Anyone in the software business knows what updates are, so one question that pops to mind here in this area with the rapid growth in devices, will we be needed to do an "update" on devices like we do on our computers at some point in time, and what about "beta", something to ponder. BD
National health watchdog Drug Controller General of India is seeking co-operation from US Food and Drug Administrator for effective regulation, particularly for medical devices and clinical trials in the country. We have identified five areas for co-operation with the US FDA, which includes new drugs, medical devices, clinical trials, pharmacology and IT and IT-enable services (in healthcare), Drug Controller General of India (DCGI) Surinder Singh said.
He said DCGI sought help of the USFDA particularly for medical devices and clinical trials, as there was already a system in place for the rest of the areas. As per the discussions held between DCGI and its counterpart, experts from the USFDA would hold workshops and training sessions in the country for Indian inspectors to help them in better monitoring of the healthcare industry. Experts from US authorities have agreed to come here and would train our people in the field of inspecting and auditing medical devices and clinical trial sector, he added.
Drug regulator keen on USFDA tie-up for trials, medical-devices - The Financial Express
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