India’s Central Drugs Standard Control Organisation (CDSCO) has released a notice concerning the regulation of certain medical devices.
In February 2019, the agency decreed that all implantable medical devices, CT scanners, MRIs, defibrillators, PETs, dialysis machines, X-ray machines and bone marrow cell separators would be classified as drugs instead of devices as of 01 April 2021. Importers and manufacturers are required to obtain the relevant import/manufacturing licence from the Central Licencing Authority or State Licencing Authority in light of this change to the classification of these devices. However, many importers and manufacturers have requested additional time to obtain licences stating that the volume of procedural work such as audits and product testing requirements means they are unable to meet this deadline.
Recognising this issue and acknowledging the request for more time, the CDSCO notice states that importers and manufacturers who are already importing/manufacturing any of these devices and who have already submitted applications for new licences to the central or state licencing authorities, will have an additional 6 months from the issue of the notice to comply with the change.
Click here to view the notice in full.