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2023-07-18T10:29:36
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REGISTRATION OF CLASS A (NON-STERILE AND NONMEASURING) MEDICAL DEVICES19G. Application of this Chapter.― (1)

REGISTRATION OF CLASS A (NON-STERILE AND NONMEASURING) MEDICAL DEVICES 19G. Application of this Chapter.― (1) This Chapter shall be applicable to all non-sterile and non-measuring devices classified as Class A medical devices as per the First Schedule (herein in this chapter referred to as Class A non-sterile and non-measuring medical device). (2) The medical devices referred to in sub-rule (1) shall be registered through an identified online portal established for the purpose. 19H. Uploading of information for registration.― (1) The manufacturer of a Class A non-sterile and non-measuring medical device shall upload the information specified in sub-rule (2) relating to that medical device for registration on the Online System for Medical Devices. (2) The manufacturer shall upload the following in the Online System for Medical Devices, namely:― (i) name and address of the manufacturing site; (ii) details of Class A non-sterile and non-measuring medical devices to be provided: Generic name Brand Name (if registered under the Trade Marks Act, 1999) Model No (if any) Intended use Material of construction Dimension (if applicable) Shelf life (if applicable) (1) (2) (3) (4) (5) (6) (7) (iii) an undertaking from the manufacturer stating that the proposed device is a Class A non-sterile and non-measuring medical device, as per the First Schedule;

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