An applicant who is aggrieved by the decision of the Central Licensing Authority under sub-rule (10), may file an appeal within fortyfive days from the date of receipt of such rejection before the Central Government, which may after such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days. 14. Duties of Notified Body A registered Notified Body, referred to in rule 13, shall carry out its duties and functions, in respect of Class A 4 [(other than non-sterile and nonmeasuring)] or Class B medical devices as specified in Part II of the Third Schedule. 15. Procedure to be adopted by Notified Body A registered Notified Body shall carry out its duties and functions either by itself or by any other qualified person on its behalf as per specified procedure as detailed in Part II of the Third Schedule. 16. Fees to be charged by Notified Body A registered Notified Body may charge fee from the applicant for the services rendered by it as may be determined by the Central Government. 17. Suspension and cancellation of registration certificate of Notified Body (1) The Central Licensing Authority may, after giving an opportunity to show cause as to why such an order should not be passed, by an order in writing stating the reasons therefor, cancel the registration of a Notified Body or suspend it for such period as the Central Licensing Authority thinks fit, if Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 16 of 248 in its opinion, the Notified Body has failed to comply with any provision of these rules.
Keywords
Subscribe for latest offers & updates
We hate spam too.