(ii) the applicant shall provide adequate space having regard to the nature and number of samples of medical devices proposed to be tested and evaluated: PROVIDED that the approving authority shall determine from time to time whether the space provided continues to be adequate; (iii) if it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal house and comply with the following requirements:— (a) the animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests shall be kept in air conditioned area; (b) the animals shall be suitably housed in hygienic surroundings and necessary provisions made for removal of excreta and foul smell; (c) the applicant shall provide for suitable arrangements for preparation of animal feed; (d) the applicant shall provide for suitable arrangements for quarantining of all animals immediately on their arrival in the institution; (e) the animals shall be periodically examined for their physical fitness; (f) the applicant shall provide for isolation of sick animals as well as animals under test; (g) the applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59 of 1960); (h) the applicant shall make proper arrangements for disposal of the carcasses of animals in a manner as not to cause hazard to public health.
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