India’s CDSCO Expands List of Devices Requiring Registration
India’s Central Drugs Standard Control Organization (CDSCO) is expanding its list of devices that require registration for market authorization, including all implantable devices and “other high end equipment.”
The list includes all implantable medical devices, CT scan and MRI equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separators.
The full list will be published in the official Gazette and will go into effect 12 months after the date of publication.
MHRA Streamlines Online Services for Devicemakers
The UK’s Medicines and Healthcare products Regulatory Agency issued an update on a new service that aims to provide access to medical device registration and certificates of free sale services through an online portal.
The program provides enhanced customer service through a single account with the agency. It also allows MHRA staff to interact more efficiently with customers, enabling staff to more quickly access and provide information to customers.
The agency aims to have all customers on the system by the end of the year. Customers that use the device registration service or apply for certificates of free sale will automatically be incorporated into the new system.