The Central Drugs Standard Control Organization (Medical Devices Division) (“CDSCO”) has by a notice dated 8th November, 2019 stated the requirement of an exemption from Drugs sale license for import of high tech equipments like X-ray, MRI, PET, Ultrasound, CT Scan, etc. under the Medical Devices Rules, 2017.
In light of this requirement, the importers of such equipment will soon be required to maintain all records of transactions, installations, maintenance, agreements, etc.
A proposal in this regard will be officially moved to the Drugs Technical Advisory Board (DTAB) for exemption of such equipments from Drugs Sale License under the Medical Devices Rules, 2017.
All stakeholders are requested to forward their comments/views in the email id ddcimd-cdsco@nic.in
Source: Ministry of Health and Family Welfare
