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Union of India - Section

Section 35 in The Medical Devices Rules, 2017

35. Inspection of overseas manufacturing site.

(1)On receipt of an application under sub-rule (1) of rule 34, the Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose.
(2)The applicant shall be liable to pay a fee as specified under the Second Schedule in respect of expenditure required in connection with the visit to the overseas manufacturing site under sub-rule (1).