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Union of India - Section

Section 68 in The Medical Devices Rules, 2017

68. Procedure to be adopted by medical device testing officer on receipt of sample.

(1)On receipt of the sealed package of medical device or portion thereof, from a Medical Device Officer or any other person for test or evaluation, the Medical Device Testing Officer shall compare the seals on the packet or on portion thereof with the specimen impression received separately and shall note the condition of the seals on the packet or on portion thereof.
(2)After completion of test or evaluation, the Medical Device Testing Officer shall forthwith furnish a report to the Medical Device Officer in triplicate in Form MD-32 of the result of the test or evaluation along with full protocols of the test or evaluation applied.