The Central Drugs Standard Control Organization (Medical Devices Division) has issued a notice on 8th November, 2019 which states the requirement for an exemption from Drugs sale license ( 20B &21B) for import of high tech equipment like X-ray, MRI, PET, Ultrasound, CT Scan, etc. under the Medical Devices Rules, 2017.
Import license is issued by CDSCO in India for an individual or industry having wholesale or manufacturing license for medical devices and now as per the DCGI notice, importers of such equipment need to maintain all records of transactions, installations, maintenance and agreements.
Accordingly, a proposal in this regard will be officially moved to Drugs Technical Advisory Board (DTAB) for exemption from drugs sale license for such equipment under Medical Devices Rules, 2017
Therefore All stakeholders are requested to forward their comments at ddcimd-cdsco@nic.in.
Click here to read the notification
