(C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act; 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;