The CDSCO brought about a new amendment on 3rd November, 2021 wherein all the following rules regarding CT scan equipment, All Implantable Devices, MRI equipment etc. as Drugs will be effective from 1st April, 2021. In the old notice all the manufacturers/importers must undergo the licensing process  for the above mentioned devices effective from 1st April, 2021. The Public Notice dated 18.04.2021 on the subject cited matter was issued by CDSCO. Various stakeholders have expressed their concerns that due to Covid-19 disruption there is unpreparedness in complying with regulatory requirements within the prescribed timelines framed by CDSCO, which leads to disruption of supply chain & access to patients around India.

To ensure smooth supply chain and access to the patients and around India, with the approval of MOHFW,  the CDSCO has decided who is already importing /manufacturing of any of the above mentioned medical devices, the application will be be valid till 30th June, 2022 or till the time the Central License Authority or State License Authority or takes a decision on the said application

If the applicant has submitted an incomplete application, they are required to ensure submission of all the necessary documents by 31st March, 2022. Incomplete applications will be disposed within three months from the date of receipt of the complete application. The importer/manufacturer of above said medical devices must obtain an import/manufacturing license for the above said devices by 30th June, 2022. The importer label containing the license number must be affixed on the device if imported into India after 1st July, 2022. Without this license, manufacturers would not be able to continue their sales in India.

Source: CDSCO