India’s moves to strengthen regulations on the sale of medical devices are creating significant task lists for manufacturers, as registration deadlines approach for obtaining import and manufacturing licenses for devices that did not previously require such approvals.
Beginning in November and extending through April 2021, applications must be submitted for ultrasound equipment, nebulizers, blood pressure monitors, glucometers, digital thermometers, CT scan, PET and MRI equipment, defibrillators, dialysis machines, x-ray machines, bone marrow cell separators, MRI equipment, and implantable medical devices.
Products lacking valid registrations will not be permitted for importation or sale, according to India’s Central Drugs Standard Control Organization (CDSCO), the country’s regulatory authority for medical devices.