Moving to strengthen its regulations of medical devices offered for sale in India, the nation’s medical device regulatory authority announced it will mandate the registration of eight categories of devices that did not previously require such approval.
The decision by India’s Central Drugs Standard Control Organization (CDSCO) affects defibrillators, dialysis machines, PET equipment, CT scan equipment, x-ray machines, bone marrow cell separators, MRI equipment and implantable medical devices.
To comply with the new requirement, both manufacturers and importers of the products will need to apply for import licenses within the next year. Products lacking valid registrations will not be permitted for importation or sale after April 1, 2020.
Other changes announced by CDSCO include revamping laws affecting medical devices in order to separate them completely from those pertaining to pharmaceuticals. The changes are designed to enable medical devices sold in the country to be traced in order to better ensure patient safety.