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A registered Notified Body whose registration has been suspended or cancelled under sub-rule (1) may, within t

A registered Notified Body whose registration has been suspended or cancelled under sub-rule (1) may, within thirty days of the receipt of a copy of the order by it, prefer an appeal to the Central Government and the Central Government may, after giving the Notified Body an opportunity of being heard, confirm, reverse or modify such order. (3) The registration of a Notified Body with the Central Licensing Authority shall be deemed to have been cancelled with effect from the expiry of the date of the validity of its accreditation by a National Accreditation Body. 18. Medical Device Testing Officer and Medical Device Officer (1) The Central Government may designate a Government Analyst appointed under section 20 of the Act as Medical Device Testing Officer. (2) The Central Government or, as the case may be, the State Government, may designate an Inspector appointed under section 21 of the Act as Medical Device Officer. (3) The Medical Device Testing Officer and Medical Device Officer designated under sub-rule (1) and sub-rule (2) respectively, while exercising powers and duties under the Act and these rules, shall be deemed to have been appointed as the Government Analyst and the Inspector, respectively. 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 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 17 of 248 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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