High-Risk Medical Device Makers And Importers Get Six-Month Extension

Existing manufacturers and importers of high-risk medical devices will be able to continue importing and manufacturing the devices for another six months if they have applied for licences, the government said on Thursday.

The Central Drugs Standard Control Organisation (CDSCO) had set October 1 as the deadline for bringing ‘class C’ and ‘class D’ medical devices under regulation as part of quality control efforts. Several manufacturers had submitted applications to obtain the licences, but the government failed to provide them on time, according to a media report by ET.

“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 belonging to categories such as ventilators, imagining equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots and oncology treatment linear accelerator, can’t be sold from October 1 without a manufacturing licence, according to the new regulation.

However, manufacturers said they had filed for a licence in July but were still awaiting audits on the basis of which they will be given licences.

“At AiMeD we are relieved with this circular by the government giving a six-month reprieve to those manufacturers who had timely applied for a manufacturing licence but could not get it due to challenging application review and processing,” said Rajiv Nath, forum coordinator, Association of Indian Medical Devices Industry (AiMeD).