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Conditions
2023-06-08T05:17:13
Accredited Consultants Pvt Ltd
Conditions of test licence to manufacture for test, evaluation, clinical investigations, etc.A licence in Fo

Conditions of test licence to manufacture for test, evaluation, clinical investigations, etc. A licence in Form MD-13 under rule 31 shall be subject to the following conditions, namely:— (a) the licensee shall use the medical device manufactured under licence granted under sub-rule (3) of rule 31 exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or training at the place specified in the licence; (b) the licensee shall allow any Medical Device Officer to enter, with or without notice, the premises where the medical device are manufactured and to satisfy himself that only clinical investigations, test, evaluation, examination, demonstration or training is being conducted on such device; (c) the licensee shall maintain a record of the quantity of medical device manufactured, tested and stocked and its disposition.Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 34 of 248 33. Cancellation of test licence to manufacture for test, evaluation, clinical investigations, etc. (1) Where any licensee under rule 31 contravenes any provision of these rules, the Central Licensing Authority, shall, issue a show cause notice to such licensee asking, as to why an order should not be made to cancel the licence. (2) The Central Licensing Authority shall, after giving an opportunity to the licensee to explain in writing licensee's defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order. (3) A licensee, whose licence has been cancelled, may appeal to the Central Government within forty-five days from the date of the order.

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