Existing manufacturers and importers of high-risk medical devices can continue to import and manufacture the devices for another six months if they have applied for licences, the government announced on Oct 12, bringing much-needed relief to the industry.
As part of quality control efforts, the Central Drugs Standard Control Organisation (CDSCO) set an October 1 deadline for bringing 'class C' and 'class D' medical devices under regulation. Several manufacturers submitted applications for the licences, but the government did not provide them on time.
“It has been decided that, in case, if an existing importer/ manufacturer who is already importing/ manufacturing any of the above said Class C or Class D Medical Devices, has submitted application to Central Licensing Authority, for grant of import /manufacturing licence in respect of the said devices) under the provisions of Medical Devices Rules, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) up to six months from the date of issue of this order or till the time, the Central Licensing Authority, takes a decision on the said application, whichever is earlier,” said a CDSCO circular dated October 12.
Medical devices in these categories, such as ventilators, imaging equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots, and oncology treatment linear accelerators, are prohibited from being sold without a manufacturing licence beginning October 1. Several manufacturers, however, stated that they had filed for a licence in July but were still awaiting audits on the basis of which they will be granted licences.