- In these rules, unless the context otherwise requires,-(a)"academic clinical study" means a clinical study conducted for academic purpose on a medical device for the approved or a new intended use, new material of construction, new improved design or new population;(b)"Act" means the Drugs and Cosmetics Act, 1940 (23 of 1940);(c)"active diagnostic medical device" means any active medical device used, whether alone or in combination with other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity;(d)"active medical device" means a medical device, the operation of which depends on a source of electrical energy or any other source of energy other than the energy generated by human or animal body or gravity;(e)"active therapeutic medical device" means any active medical device used, whether alone or in combination with any other medical device, to support, modify, replace or restore biological functions or structures, with a view to the treatment or alleviation of any illness, injury or handicap;(f)"authorized agent" means a person including any firm or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India;(g)"body orifice" means any natural opening in a human body including the external surface of any eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy;(h)"Central Licensing Authority" means the Drugs Controller General of India appointed by the Central Government;(i)"central medical devices testing laboratory" means a medical devices laboratory established or designated by the Central Government under rule 19 and shall be deemed to be a Central Drug Laboratory established for the purpose of section 6 of the Act;(j)"change in the constitution of a licencee" in relation to,-(i)a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa;(A)its conversion from a private to a public company, or from a public to a private company; or(B)any change in the ownership of shares of more than fifty per cent. of the voting capital in the body corporate or in case of a body corporate not having a share capital, any change in its membership; and where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change in the constitution of that other body corporate within the meaning of this clause;(ii)a company means-(k)"clinical evidence" means, in relation to,-(i)an in vitro diagnostic medical device, is all the information derived from specimen collected from human that supports the scientific validity and performance for its intended use;(ii)a medical device, the clinical data and the clinical evaluation report that supports the scientific validity and performance for its intended use;(l)"clinical investigation" means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness;(m)"clinical investigation plan" means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical investigation;(n)"clinical performance evaluation" means the systematic performance study of a new in vitro diagnostic medical device on a specimen collected from human participants to assess its performance;(o)"clinical research organization" means any entity to whom a sponsor may transfer or delegate one or more of its functions and duties regarding conduct of clinical investigation or clinical performance evaluation;(p)"conformity assessment" means the systematic examination of evidence generated and procedures undertaken, by the manufacturer to determine that a medical device is safe and performs as intended by the manufacturer and therefore conforms to the essential principles of safety and performance for medical devices;(q)"controlling officer" means the officer designated under rule 10;(r)"custom made medical device" means a medical device made specifically in accordance with a written prescription of a registered medical practitioner, specialized in the relevant area, under his responsibility for the sole use of a particular patient, but does not include a mass production of such device;(s)"Ethics Committee" means the committee referred to in rule 50;(t)"Form" means forms specified in Appendix to these rules;(u)"Good Clinical Practices Guidelines" means Good Clinical Practices Guidelines issued by Central Drugs Standards Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India;(v)"intended use" means the use for which the medical device is intended according to the data supplied by the manufacturer on the labeling or in the document containing instructions for use of such device or in promotional material relating to such device, which is as per approval obtained from the Central Licensing Authority;(w)"invasive device" means a device which, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body;(x)"investigational medical device" in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified in clause (zb),-(i)which does not have its predicate device as defined in clause (zm); or(ii)which is licenced under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of rule 36 and claims for new intended use or new population or new material or major design change; and is being assessed for safety or performance or effectiveness in a clinical investigation.(y)"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 utilize the manufacturing site of other licencee for manufacturing the same medical device as manufactured by the licencee at that site;(za)"long term use" means intended continuous use of a medical device for more than thirty days;(A)substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood 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;(zb)"medical device" means,-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, organization registered under sub-rule (3) of rule 83 for carrying out testing or evaluation of any medical device on behalf of a licencee 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 patients 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;(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 analyzed 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 analyze 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 authorized 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;(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 hospitalization 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 organization 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.(zx)words and expressions used but not defined in these rules, shall have the meanings respectively assigned to them in the Act and the Drugs and Cosmetics Rules, 1945.
