Draft Medical Devices (......Amendment) Rules, 2018

May 07, 2018 | by Avantis RegTech Legal Research Team

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Ministry of Health and Family Welfare has issued draft Medical Devices (......Amendment) Rules, 2018 further amending the Medical Device Rules, 2017. Vide this amendment-

In Fourth Schedule, in Part II, in item (ii), for sub-item (h), the following sub-item shall be substituted, namely:-

“In case of in vitro diagnostic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant:

Provided that, when specifically required by State Licensing 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.”

Objections and suggestions may be sent by any person to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at [email protected] within expiry of thirty (30) days from the date on which the copies of the Gazette of India these draft rules are made available to public.

[G.S.R. 412(E)]

URL: http://www.egazette.nic.in/WriteReadData/2018/185040.pdf



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