(1) These rules shall be applicable in respect of,-
(i) substances covered under sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis;
(ii) substances that are in the nature of mechanical devices covered under subclause (ii) of clause (b) of section 3; and
(iii) devices specified from time to time by the Central Government by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
(2) These rules shall come in to force from such dates as may be notified by the Central Government after their final publication in the Official Gazette:
Provided that the Central Government may notify different dates in respect of different class or category of medical devices.
biotech Highlight biotech Highlight biotech Highlight 3
(3) Medical device already marketed in India prior to the commencement of these rules shall continue to be marketed as hitherto before subject to the condition that the manufacturer shall provide evidence of previous sale in India and apply for licence within a period of one hundred and eighty days from the date the device is notified under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
(4) The Central Government shall, by notification, specify the date from which medical device referred in clause (2) shall be regulated in accordance with these rules.
(5) Medical device already notified under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and marketed in India prior to the commencement of these rules shall continue to be marketed as hitherto before till the expiry of eighteen months or the current validity of the licence, whichever is later, from the commencement of these rules.
Explanation: For the purposes of these rules, the in vitro diagnostic medical devices which are already marketed in India and governed under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 shall be deemed to be medical devices and shall also continue to be marketed as hitherto before till the expiry of eighteen months or the current validity of the licence, whichever is later, from the commencement of these rules.
Definitions. 3. In these rules, unless the context otherwise require,-
(i) “academic clinical study” means a clinical study conducted on registered or approved medical device for any new intended use, new material of construction, new design or new population for academic purpose;
(ii) “accessory” means an article, which whilst not being a device, is intended specifically by the manufacturer to be used together with a specific medical device, to enable the medical device to be used in accordance with its intended use by the manufacturer of the device;
(iii) “Act” means the Drugs and Cosmetics Act, 1940 (23 of 1940);
(iv) "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;
(v) “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;
(vi) “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 biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight 4 the treatment or alleviation of any illness, injury or handicap;
(vii) “authorised agent” means a person including any firm, organisation who has been appointed by the overseas manufacturer through a power of attorney authenticated in India either by a Magistrate of First Class or by Indian Embassy in the said country of origin or by an analogous authority through apostille to undertake import for sale or distribution of medical device in India;
(viii) “body orifice” means any natural opening in a human body, the external surface of any eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy;
(ix) “Central Licensing Authority” means the Drugs Controller General of India appointed by the Central Government;
(x) “central medical devices testing centres” means a medical devices testing centre established or designated by Central Government under sub-rule (1) of rule 14;
(xi) “change in the constitution” in respect of,-
(i) a firm means to change in proprietorship to partnership or vice versa;
(ii) a company means-
(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 in the body corporate or in the 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 clause
(a) or clause (b);
(xii) “clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness;
(xiii) “clinical investigation plan” means a document containing background, objective, rationale, design, methodology including performance, management, adverse event, withdrawal and statistical consideration pertaining to clinical investigation;
(xiv) “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 safety and performance;
(xv) “clinical research organisation” means any entity to whom a sponsor may transfer or delegate one or more of its functions and duties regarding conduct of clinical investigation;
(xvi) “conformity assessment” means the systematic examination of evidence biotech Highlight biotech Highlight biotech Highlight 5 generated and procedures undertaken, by the manufacturer, under the provisions of these rules, 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;
(xvii) “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;
(xviii) “Ethics Committee” means committee referred under rule 44;
(xix) “Form” means forms specified in Appendix to these rules.
(xx) “Good Clinical Practices Guidelines” means Good Clinical Practices Guidelines issued by Central Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
(xxi) “intended use” means use for which a medical device is intended according to the specifications laid down by its manufacturer as stated on any or all of the following:
(i) the label of medical device;
(ii) the instructions for use of medical device;
(iii) promotional materials in relation to medical device;
(xxii) “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;
(xxiii) “investigational medical device” means a device which does not has a predicate device approved by the Central Licensing Authority being assessed for safety or performance in a clinical investigation including medical devices already in the market that are being evaluated for new intended uses, new populations, new materials or major design changes;
(xxiv) “licence” means a licence granted by the State Licensing Authority or Central Licensing Authority in Form MD7, Form MD11, Form MD13, Form MD15 or Form MD17, as the case may be;
(xxv) “loan licence” for manufacture means a licence, which a State Licensing Authority or Central Licensing Authority, as the case may be, may issue to an applicant who intends to utilize the manufacturing facility of another licence holder to manufacture medical device;
(xxvi) “long term use” means intended continuous use of a medical device for more than thirty days;
(xxvii) “manufacture” in relation to,-
(i) medical device includes any process for designing, making, assembling, configuring, finishing, packing, sterilizing, labelling or adapting with a biotech Highlight biotech Highlight biotech Highlight 6 view to sell or distribute or stock but does not include a custom made device;
(ii) in vitro diagnostic medical device includes any process for designing, making, assembling, configuring, labeling or packing with a view to sell or distribute or stock.
(xxviii) “manufacturer” means a person who himself manufactures a medical device and includes any other person who undertakes such manufacturing activity on his behalf;
Explanation: for the purpose of these rules, the person who has marketed or promoted any medical device or used any other similar expression printed, written, embossed or put in any manner on the medical device, shall be construed as the manufacturer.
(xxix) “medical device” means,-
(a) any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software, intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes of,-
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices;
(vi) control of conception;
which does not achieve the primary intended action in or on the human body or animals by any pharmacological or immunological or metabolic means, but which may be assisted in its intended function by such means, and covered under sub-clause (iv) of clause (b) of section 3of the Drugs and Cosmetics Act, 1940 (23 of 1940);
(b) an accessory to such an instrument, apparatus, appliance, material or other article;
(c) substances covered under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) used for in vitro diagnosis which is a reagent, calibrator, control material, kit, instrument, apparatus, equipment or system, specimen receptacle, whether used alone or in combination with any other reagent, calibrator, control material, kit, instrument, apparatus, equipment or system, that is intended by its manufacturer to be used in vitro for examination of any specimen, including any blood or tissue donation, derived biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight biotech Highlight 7 from the human body, solely or principally for the purpose of providing information,-
(i) concerning a physiological or pathological state or a congenital abnormality;
(ii) to determine the safety and compatibility of any blood or tissue donation with a potential recipient thereof; or
(iii) to monitor therapeutic measures;
(d) substances in the nature of medical devices covered by sub-clause (ii) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
(xxx) “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;
(xxxi) “medical device officer” means an officer appointed or designated by the Central Government or State Government, as the case may be, under rule 13;
(xxxii) “medical device testing officer” means an officer appointed or designated by the Central Government or State Government, as the case may be, under rule 13;
(xxxiii)"near-patient testing" means as 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 perhaps rapidly enough to affect immediate patient management;
(xxxiv) “new in vitro diagnostic medical device” means an in vitro diagnostic medical device if:
(a) there has been no such device continuously available on the market in India during previous four years for the relevant analyte or other parameter related to such device; or
(b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter related to such device on the market in India during previous four years;
(xxxv) “Notified Body” means a body corporate or other legal entity, notified by the Central Government, as competent body to carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for establishing conformity with standards and other requirements under these rules;
(xxxvi) “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 the performance of the in vitro diagnostic medical device for its intended use.
(xxxvii) “Post Marketing Surveillance” means systematic process to collect and analyze information gained from medical device that have been placed in the biotech Highlight 8 market;
(xxxviii) “predicate device” means a device, first time and first of its kind, approved by the Central Licensing Authority;
(xxxix) “reagent” means a chemical, biological or immunological component, solution or preparation intended by the manufacturer to be used as in vitro diagnostic medical device;
(xl) “serious adverse event” means an untoward medical occurrence that led to,-
(i) a death;
(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;
(iii) foetal distress, foetal death or a congenital abnormality or birth defect.
(xli) “short term use” means intended continuous use of a medical device for not less than sixty minutes but not more than thirty days;
(xlii) “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;
(xliii) “sponsor” includes a person, 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.
(xliv) “State Licensing Authority” means the authority designated by the State Government under sub-rule (2) of rule 8;
(xlv) “state medical devices testing centre” means a medical devices testing centre established by State Government under sub-rule (2) of rule 14;
9
(xlvi) “transient use” means a device intended for continuous use for less than sixty minutes; means intended continuous use of a medical device for less than sixty minutes;
(xlvii) “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.
Part II Regulation of Medical Device.
Criteria for classification of medical devices.
4. Medical devices shall be classified, based on the severity of risk associated with a medical device, as specified in rule 5.
Classification of medical devices.