Fresh application in case of change in constitution In case of change in constitution of a licensee, after grant of licence under sub-rule (1) of rule 36, an application shall be made under sub-rule (1) of rule 34 for grant of licence within a period of one hundred and eighty days from the date of such change in constitution: PROVIDED that the existing licence shall be deemed to be valid till such time, he fresh licence is issued or application is rejected by the Central Licensing Authority. Explanation: For the purpose of this rule, the licensee shall include overseas manufacturer who executed the power of attorney in favour of authorised agent. 40. Test licence for import for test, evaluation, clinical investigations, etc. (1) Notwithstanding anything contained in these rules, any medical device or in vitro diagnostic medical device may be imported for the purpose of clinical investigations or test or evaluation or demonstration or training. (2) The person who desires to import medical device under sub-rule (1), shall apply for an import licence for test, evaluation or demonstration or Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India training to the Central Licensing Authority in Form MD-16, accompanied by such fee as specified in the Second Schedule. (3) On receipt of the application under sub-rule (2), the Central Licensing Authority shall determine, the quantity of the medical devices, after taking into account the requirement for clinical investigation, approved clinical investigation plan, and information and documents submitted by the applicant.
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