Central medical device testing laboratory (1) The Central Government may, by notification, establish Central medical devices testing laboratory for the purpose of, — (a) testing and evaluation of medical devices; or (b) functioning as an appellate laboratory; or (c) to carry out any other function as may be specifically assigned to it. (2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for carrying out test and evaluation of Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. medical devices as central medical devices testing laboratory for the purposes specified in sub-rule (1): PROVIDED that no medical devices testing laboratory, shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories: 5 [PROVIDED FURTHER that the testing laboratories of State Governments and Central Government shall be exempted from the requirement of the accreditation by the National Accreditation Board for Texting and Calibration Laboratories for a period of two years from the date of coming into force of the Medical Devices (Fifth Amendment) Rules, 2019.]
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