2023-05-08T05:35:06
"licence" means a licence granted by the State Licensing Authority or the
Central Licensing Authority in Form MD-5, Form MD-6, Form MD-9, Form
MD-10, Form MD-15, Form MD-17 or Form MD-19, as the case may be;
(z) "loan licence" means a licence issued for manufacturing a medical device
by the State Licensing Authority or the Central Licensing Authority, as the
case may be, to a person who intends to utilise the manufacturing site of other
licensee for manufacturing the same medical device as manufactured by the
licensee at that site;
(za) "long term use" means intended continuous use of a medical device for
more than thirty days;
(zb) "medical device" means, —
(A) substances used for in vitro diagnosis and surgical dressings,
surgical bandages, surgical staples, surgical sutures, ligatures, blood
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and blood component collection bag with or without anticoagulant
covered under sub-clause (i);
(B) substances including mechanical contraceptives (condoms,
intrauterine devices, tubal rings), disinfectants and insecticides notified
in the Official Gazette under sub-clause (ii);
(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;
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(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;
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(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.
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