CDSCO grants 6-month extension to manufacturers of medical devices for import
Source: Financial Express
It is noteworthy that the regulatory body had set a deadline of October 1 for bringing “class C” and “class D” medical devices, including ventilators, imaging equipment, and surgical robots, under the new regulation.
The Central Drugs Standard Control Organization (CDSCO) has granted an extension of six months to the existing manufacturers and importers of high-risk medicalIt is noteworthy that the regulatory body had set a deadline of October 1 for bringing “class C” and “class D” medical devices, including ventilators, imaging equipment, and surgical robots, under the new regulation. devices i if they have already submitted applications for licenses.
In a notification dated 12 October 2023, the drug regulator said that “if an existing importer/manufacturer who is already importing/manufacturing Class C or Class D medical devices, has submitted an application to Central Licensing Authority, for grant of import/manufacturing license in respect of the said device(s) 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) upto 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.”
It is noteworthy that the regulatory body had set a deadline of October 1 for bringing “class C” and “class D” medical devices, including ventilators, imaging equipment, and surgical robots, under the new regulation.
According to the new regulation, medical devices under these categories cannot be sold without a manufacturing licence after the deadline. Reportedly, many manufacturers raised their concerns regarding the deadline as they awaited licenses, which they had applied for months in advance.
According to media reports, the Association of Indian Medical Device Industry (AiMED), an organisation representing domestic medical device makers, also sought an extension of this deadline.
Last month, the association raised concerns about the resource constraints of the CDSCO in conducting timely inspections and issuing manufacturing licences before the stipulated deadline in a letter to Health Minister Mansukh Mandaviya.
Reportedly, this decision allows the medical devices industry to continue operations while awaiting license approvals.
