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(1) "clinical investigation" means the systematic study of an investigational medical devi...

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(v) details of competent technical staff, under whose direction and supervision the sales ...

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(1) "clinical investigation" means the systematic study of an investigation medical device...

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"notified" means notified in the Official Gazette by the Central Government, (zj) "Notif...

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9.0 Analytical performance characteristics: 9.1 Accuracy of measurement: This section shou...

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3. Procedure for audit: The notified body shall carry out the audit in the following manne...

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1.2 Information regarding sterilization of the device (whether it is sterile or non-steril...

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Illustration: Anticoagulant monitoring, diabetes management, and testing for C-reactive pr...

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DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the audit ...

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