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.
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