Rule 28 of the Medical Devices, Rules 2015 provides that clinical investigations of a medical device on human subjects shall be carried out “in accordance with the spirit of the Helsinki Declaration, which shall include each step in the clinical investigation from first consideration of the need and justification of the study to publication of the results”.
Rule 34 of the Rules refers to pre-clinical studies and provides that relevant documentation includes the report, certification or declaration of:
(a) biocompatibility tests conducted on materials used in a medical device;
(b) pre-clinical physical tests conducted on the medical device; and
(c) pre-clinical animal studies to support the probability of effectiveness in humans.
It further provides that the report should contain information on “the objectives, methodology, results, discussion and conclusions of the testing”.