(1) An application for grant of permission to conduct clinical investigation for investigational medical device shall be made to the Central Licensing Authority in Form MD20 by a sponsor and shall be accompanied with information specified in the Seventh Schedule:
Provided, that the investigational medical devices approved for marketing by United States Food and Drug Administration shall be waived off from the requirements of the clinical investigation under this Part.
(2) An application for grant of permission to conduct,-
(a) a pilot clinical investigation or first in human study, on an investigational medical device in India shall be made as referred to in sub-rule (1) accompanied with fee as specified in the Second Schedule along with the information as specified in the Seventh Schedule.
(b) a pivotal clinical investigation on an investigational medical device shall be made on the basis of data emerging from pilot clinical investigation, as referred in biotech Highlight biotech Highlight biotech Highlight 26 sub-rule (1), accompanied with a fee as specified in the Second Schedule:
Provided that no fee shall be paid by any institute, organization, hospital run or funded by the Central Government or State Government, as the case may be, for conduct of clinical investigation.
(3) No permission for conduct of academic clinical study on registered or approved medical device shall be required, where,-
(a) the investigation is approved by the Ethics Committee; and
(b) the data generated shall not be used to furnish it to the Central Licensing Authority for manufacture or import to market investigational medical device in the country.
(4) The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirement of conducting clinical investigation for reasons to be recorded in writing before granting permission to import or manufacture investigational medical device in the country.
(5) Medical device requiring clinical investigation but claiming substantial equivalence to a predicate device shall not be marketed unless the Central Licensing Authority has approved it.
Explanation-. For the purposes of this sub-rule, a device shall be deemed to be substantially equivalent in comparison to a predicate device, if it has,- i. the same intended use and technological characteristics; or ii. same intended use and different technological characteristics and demonstrate that the device is as safe and effective as the predicate device;
(6) The Central Licensing Authority, after being satisfied with the information furnished along with application under sub-rule (1), may grant permission to conduct clinical investigation for an investigational medical device in Form MD21:
Provided that the Central Licensing Authority shall, where the information including clinical investigation is inadequate as per the Seventh Schedule, intimate the applicant in writing, within ninety days from the date of application or such extended period, not exceeding a further period of thirty days, as the Central Licensing Authority may, for reasons to be recorded in writing, permit, the conditions which shall be satisfied before permission could be considered:
Provided that if the applicant has not furnished the required information sought by the Central Licensing Authority, within ninety days from the date of intimation, it may reject the application for reasons to be recorded in writing.
Condition for permission.
46. After grant of permission referred in rule 45 the following conditions shall be complied with by the applicant,-
(i) clinical investigation shall be initiated under the supervision of an approved Ethics Committee;
(ii) clinical investigation shall be conducted in compliance with the approved clinical investigation plan, Good Clinical Practices Guidelines and provisions biotech Highlight biotech Highlight biotech Highlight 27 of the Seventh Schedule;
(iii) clinical investigation shall be registered with the Clinical Trial Registry of India before enrolling the first patient for such clinical investigation;
(iv) annual status report of each clinical investigation, as to whether it is ongoing, completed or terminated, shall be submitted to the Central Licensing Authority by the sponsor, and in case of termination of any clinical investigation, the detailed reasons for the same shall also be communicated to the Central Licensing Authority within thirty days of such termination;
(v) information about any report of suspected unexpected serious adverse event occurring during clinical investigation on the subject, shall, after due analysis, be submitted to the Central Licensing Authority within fifteen days of the sponsor coming to know about its occurrence as specified in the Seventh Schedule and in compliance with the procedure specified in these rules.
(vi) in case of an injury or death during clinical investigation of the subject of a clinical investigation, the applicant shall provide complete medical management and compensation in case of clinical investigation related injury or death in accordance with these rules.
(vii) the premises of the sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical investigation sites shall be open to inspection by officers of Central Licensing Authority or authorised personnel of Notified Bodies under these rules, to verify compliance of the requirements of these rules for conduct of clinical investigation.
(viii) the clinical investigation shall be initiated by enrolling first patient within the period of one year from the date of grant of permission, failing which prior permission from the Central Licensing Authority is required.
(ix) the Central Licensing Authority may impose any other condition while granting permission in respect of specific clinical investigations, if considered necessary, regarding the objective, design, subject population, subject eligibility, assessment, conduct and treatment of clinical investigation.
Suspension or cancellation of permission.