"notified" means notified in the Official Gazette by the Central Government, (zj) "Notified Body" means a body corporate or other legal entity, registered under rule 13 as a body competent to carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for establishing conformity with standards; (zk) "performance evaluation" in relation to in vitro diagnostic medical device means any systematic investigation by which data is assessed and analysed to establish or verify performance of the in vitro diagnostic medical device for its intended use; (zl) "Post Marketing Surveillance" means systematic process to collect and analyse information gained from medical device that have been placed in the market; (zm) "predicate device" means a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for licence in India; (zn) "Quality Management System" means requirements for manufacturing of medical devices as specified in the Fifth Schedule; (zo) "reagent" means a chemical, biological or immunological component, solution or preparation intended by the manufacturer to be used as in vitro diagnostic medical device; (zp) "recall" means any action taken by its manufacturer or authorised agent or supplier to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied, because the medical device, — (a) is hazardous to health; or (b) fails to conform to any claim made by its manufacturer relating to its quality, safety or efficacy; or (c) does not meet the requirements of the Act and these rules; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 8 of 248 (zq) "serious adverse event" means an untoward medical occurrence that leads to, — (i) a death; or (ii) a serious deterioration in the health of the subject that either— (A) resulted in a life-threatening illness or injury; or (B) resulted in a permanent impairment of a body structure or a body function; or (C) required in-patient hospitalisation or prolongation of existing hospitalization; or (D) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function; or (iii) foetal distress, foetal death or a congenital abnormality or birth defect; (zr) "short term use" means intended continuous use of a medical device for not less than sixty minutes but not more than thirty days;