Explanation : For the purpose of these rules, substances used for in vitro diagnosis shall be referred as in vitro diagnostic medical device; (zc) "medical device grouping" means a set of devices having same or similar intended uses or commonality of technology allowing them to be classified in a group not reflecting specific characteristics; (zd) "Medical Device Officer" means an officer appointed or designated by the Central Government or the State Government, as the case may be, under sub-rule (2) of rule 18; (ze) "medical devices testing laboratory" means any institute, organisation registered under sub-rule (3) of rule 83 for carrying out testing or evaluation of any medical device on behalf of a licensee for manufacture for sale; (zf) "Medical Device Testing Officer" means an officer appointed or designated by the Central Government under sub-rule (1) of rule 18; (zg) "near-patient testing" means any investigation carried out in a clinical setting or at the patient's home for which the result is available without reference to a laboratory and rapidly enough to affect immediate patient management; (zh) "new in vitro diagnostic medical device" means any medical device as referred to in sub-clause (A) of clause (zb) used for in vitro diagnosis that has not been approved for manufacture for sale or for import by the Central Licensing Authority and is being tested to establish its performance for relevant analyte or other parameter related thereto including details of technology and procedure required; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 7 of 248 (zi) "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; (zs) "specimen receptacle" means a device, whether vacuum type or not, specifically intended by its manufacturer for the primary containment of specimens derived from human or animal body; (zt) "sponsor" includes a person, an investigator, a company or an institution or an organisation responsible for the initiation and management of a clinical investigation or clinical performance evaluation in India; (zu) "State Licensing Authority" means the authority designated by the State Government under sub-rule (2) of rule 8; (zv) "transient use" means a device intended for continuous use for less than sixty minutes; (zw) "transmissible agent", for the purpose of classification of in vitro diagnostic medical device, means an agent capable of being transmitted to a person, which causes communicable, infectious or contagious disease; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 9 of 248 (zx) words and expressions used but not defined in these rules, shall have the meanings respectively assigned to them m the Act and the Drugs and Cosmetics Rules, 1945.