The Federal government of India will deliberate and take a decision on whether large hospitals should be allowed to import medical devices directly from the manufacturers. Currently, governmental rules stipulate that an import license is required to procure medical devices from original equipment manufacturers. However, there is no mention in...
India’s Regulations for Safety for Medical Devices
Indian regulations called the Materiovigilance Program of India (MvPI) to institutionalize post-marketing vigilance of medical devices to monitor patient safety throughout the country have been in place for a number of years. Under this program, a manufacturer, importer, distributor, healthcare professional, patient, or other entity can report an adverse event...
India's Health Ministry to Regulate Prices of Critical Medical Devices
Critical medical devices and diagnostic equipment will be regulated by India's health ministry. Under the Medical Devices Rules, 2017, which will come into effect from January 1, 2018, prices of devices such as catheters, stents and orthopedic implants, heart valves, intra-ocular lenses, syringes and needles will be regulated by the...