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2023-06-05T07:13:11
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Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing si

Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A 3 [(other than non-sterile and non-measuring)] or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority. (4) Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience. (5) With effect from the 1st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may make an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with a fee specified in the Second Schedule along with documents as specified in Part I of the Third Schedule. (6) The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a registration certificate in Form MD-2. (7) The Registration Certificate shall remain valid in perpetuity, unless, it is suspended or cancelled, provided the registration certificate holder deposits a registration retention fee as specified in the Second Schedule every five years from the date of its issue. (8) If the registration certificate holder fails to pay the required registration certificate retention fee on or before due date as referred to in sub-rule (7), the registration certificate holder shall, in addition to the retention fee, be liable to pay a late fee calculated at the rate of two per cent, of the registration certificate retention fee for every month or part thereof within ninety days, and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 15 of 248 (9) The Notified Body shall perform the functions as specified in Part II of the Third Schedule. (10) The Central Licensing Authority, may, in cases where the requirement specified for registration of Notified Body have not been complied with, reject the application and shall inform the applicant of the reasons for such rejection.

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