(5)Medical devices requiring clinical investigation but claiming substantial equivalence to a predicate device shall not be marketed unless the Central Licensing Authority has approved it.Explanation 1. - 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.Explanation 2. - A claim of substantial equivalence does not mean that the proposed medical device and predicate device are identical. Substantial equivalence shall be established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, bio-compatibility, standards, and other characteristics, as applicable.
