The Central Drugs Standard Control Organisation vide order dated 03.11. 2021 has provided for Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st, 2021. CDSCO, to ensure smooth transition, has also provided a relaxation to existing importer/manufacturer who is already importing /manufacturing any of those devices, and whose application has been submitted to the Central License Authority or State License Authority, as the case may be, for grant of import/manufacturing license.
Those application shall be deemed to be valid and the importer/manufacturer, can continue to import/manufacture the said device(s) up to 30.06.2022 or till the time the Central License Authority or State License Authority, as the case may be, takes a decision on the said application, whichever is earlier.
In case the applicant has submitted an incomplete application (submitted by or before 18.04.2021), is required to ensure submission of all the necessary documents to the concerned Authority, by 31.03.2022.
Central Licensing Authority or State Licensing Authority, as the case may be, shall dispose of these applications within three months from the date of receipt of complete application.
