Central Medical Device Testing Laboratory

Central Government designates five laboratories as Central Medical Device Testing Laboratory under MDR, 2017. These laboratories are being set up to provide a boost to the domestic manufacturing sector by providing adequate infrastructure for device testing based on project proposals and technical support given by the National Health Systems Resource Centre (NHSRC), a technical support institution under the health ministry. Central Government in pursuance of the powers conferred by sub-rule (2) of rule 19 of the Medical Devices Rules, 2017, hereby designates these five laboratories having facilities for carrying out test and evaluation of medical devices, as Central Medical Device Testing Laboratory for the purposes of (a) testing and evaluation; (b) functioning as an appellate laboratory; and (c) to carry out any other function as may be specifically assigned to it by the Central Government, in relation to the medical devices. The laboratories designated are duly accredited by the National Accreditation Body for Certification Laboratories.

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