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Union of India - Section

Section 19 in The Medical Devices Rules, 2017

19. 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 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.