MoH&FW proposes rules to amend Medical Device Rules

It will come into force on the date of their final publication in the Official Gazette

Ministry of Health & Family Welfare recently proposed a draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposed to make, in exercise of the powers, conferred by sections 12 and section 33 of the Drugs and Comestics Act 1940 (23 of 1940).

In the Medical Devices Rules, 2017, in Fourth Schedule, in Part II, in terms (ii) for sub-item (b), the following sub-item shall be substituted,

“(h) in case of in vitro diagnosic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant” with “Provided that, when specically required by State Increasing Authority for Class B or the Central License Authority for Class C and Class D in vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the Central Medical Devices Testing Laboratory or a Medical Device Laboratory registered under rule 83 or by any Laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories.”