(1) No person or sponsor shall conduct any clinical performance evaluation in respect of a new in vitro diagnostic device on specimen, including any blood or tissue donation, derived from the human body except under, and in accordance with, the permission granted by the Central Licensing Authority subject to such conditions and in such form and manner as specified in these rules.
(2) An application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic device shall be made to the Central Licensing Authority in Form MD22 by the sponsor and shall be accompanied with a fee as specified in the Second Schedule and along with information specified in sub-rule
(3)duly signed by the sponsor in India:
Provided that no fee shall be required to be paid by the institutes, organizations, hospitals run by the Central Government or State Government, involved in conduct of clinical performance evaluation of new in vitro diagnostic medical devices.
(3) The information specified under sub-rule (2) shall contain the following information, namely,-
(i) approval from an Ethics Committee, which is registered with the Central Licensing Authority, as prescribed in Appendix VII of the Seventh Schedule;
(ii) source and quantity of all types of samples which shall be used during evaluation;
(iii) device description including specification of raw material and finished product, data allowing identification of the device in question, proposed instruction for use, labels and regulatory status in other countries, if any;
(iv) in house performance evaluation data used to establish stability, specificity, sensitivity, repeatability and reproducibility;
(v) clinical performance evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of evaluation and number of devices concerned;
(vi) Case Report Form as prescribed in Appendix IV of the Seventh Schedule;
(vii) Undertaking by investigators as prescribed in Appendix VI of the Seventh Schedule;
(viii) the list of laboratories or other institutions taking part in the evaluation study;
(ix) the scheduled duration for evaluation and, in case of devices for selftesting, the location and number of lay persons involved;
(x) an undertaking that the device in question conforms to the requirements of these rules, apart from aspects covered by the evaluation and apart from biotech Highlight 30 those specifically itemized in the undertaking, and that every precaution has been taken to protect the health and safety of the patient, user and other persons.
(4) The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirement of conducting clinical performance evaluation for reasons to be recorded in writing for grant of permission to import or manufacture new in vitro diagnostic medical device for marketing.
(5) The Central Licensing Authority after being satisfied with the information furnished along with application under sub-rule (1) may grant permission to conduct clinical performance evaluation for anew in vitro diagnostic medical device in Form MD23:
Provided where information, as referred to in sub-rule (3) is inadequate, the Central Licensing Authority shall inform 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 requirements to be complied with as before permission may be granted:
Provided further, 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.
Conditions for permission to conduct of clinical performance evaluation.
53. After grant of permission referred in rule 52, the following conditions shall be complied with by the applicant,-
(i) clinical performance evaluation shall be conducted in compliance with the approved clinical performance evaluation plan, Good Clinical Practices Guidelines;
(ii) clinical performance evaluation shall be initiated under the supervision of an approved Ethics Committee;
(iii) clinical performance evaluation shall be registered with the Clinical Trial Registry of India before enrolling the first patient for such clinical performance evaluation;
(iv) annual status report of each clinical performance evaluation, 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 performance evaluation, the detailed reasons for the same shall be communicated to the Central Licensing Authority within 30 days of date of termination;
(v) the laboratories or other institutions taking part in the evaluation study or 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 the Central Licensing Authority authorised under these 31 rules, to verify compliance of the requirements of these rules for conduct of clinical performance evaluation.
(vi) the clinical performance evaluation shall be initiated within the period of one year from the date of grant of permission, failing which prior permission from the Central Licensing Authority shall be required.
(vii) the Central Licensing Authority may impose any other condition while granting permission in respect of specific clinical performance evaluation, if considered necessary, regarding the objective, design, subject population, subject eligibility, assessment, conduct and treatment of clinical performance evaluation.
Suspension or cancellation of permission.