The Central Drugs Standard Control Organization (CDSCO) has granted an extension of three months to existing manufacturers and importers of high-risk medical devices if they have applied for licences before September 30, 2023.
“It has been decided that, in case, if an existing importer/manufacturer who is already importing/manufacturing any Class C or Class D medical devices, has submitted an application to the central licensing authority for the grant of an 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,” the drug regulator said in a circular dated May 16.
The step comes after several medical device associations and stakeholders had sent representations to the drug regulator, asking for an extension to adhere to the new licensing regulations.
Last year, the drug regulator had passed a new regulation, where high-risk medical devices belonging to Class C and Class D, such as ventilators, imaging equipment, oxygen therapy equipment, nebulisers, X-ray equipment, surgical robots, and oncology treatment linear accelerators could not be sold from October 1 without a manufacturing licence.
However, several manufacturers were not able to get licences from the government by the end of the deadline, awaiting government audits on the basis of which they will be given licences.
CDSCO had then granted a six-month extension to manufacturers and importers of medical devices. Another extension of three months has now been granted to medical device manufacturers, allowing the medical devices industry to continue operations while awaiting licence approvals.
Welcoming the CDSCO’s decision to grant high-risk medical device manufacturers an extension to seek licences, Pavan Choudary, chairman of the Medical Technology Association of India (MTaI), said that the move will ensure business continuity for the industry in these prime times, enabling it to operate without any break in the supply chain or any halt at the port offices.
SOURCE – Business Standard
