Conditions for registration of medical device testing laboratory The following conditions shall be complied with by the applicant before grant of registration, namely:— (i) the premises where the test or evaluation shall be carried out shall be well lighted and properly ventilated except where the nature of tests of any medical device warrants otherwise, and wherever necessary, the premises shall be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests, microbiological tests, etc.; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 66 of 248 (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.