2023-07-18T04:40:19
REGISTRATION OF CERTAIN MEDICAL DEVICES
19A. (1) This Chapter shall be applicable to all devices notified under clause
(b) of section 3 of the Act except the medical devices and devices specified in the Annexure of Eighth Schedule of these rules.
(2) The Medical devices referred in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose:
PROVIDED that registration under this Chapter shall be on voluntary basis for a period of eighteen months from the commencement of this Chapter there after it shall be mandatory. 19B. (1) The manufacturer of a medical device shall upload the information specified in sub-rule (2) relating to that medical device for registration on the "Online System for Medical Devices" established by the Central Drugs
Standard Control Organisation for this purpose.
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