CDSCO has issued a notice recently regarding intended uses of implantable medical devices, as stipulated in the Fifth Schedule (Clause 3.5) of Medical Devices Rules, 2017. According to this clause, Implantable Medical Devices are intended:
(a) To be totally or partially introduced into the human or animal body or a natural orifice, or
(b) To replace an epithelial surface or the surface of the eye; by surgical intervention, and which is intended to remain after the procedure for at least thirty days, and which can only be removed by medical or surgical intervention.
As per recent improvements in the list of devices covered by the Medical Devices Rules, 2017, implantable medical devices are now also regulated by CDSCO. Clarification about the definition of implantable medical devices ensure the regulation is carried out smoothly.
Notice regarding all implantable devices