1.8 Domestic price of the device in the currency followed in the country of origin. ...

1.1 Introductory descriptive information on the in vitro diagnostic medical device, t ...

REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE ...

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

2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationa ...

PROVIDED that no fee shall be required to be paid by the institutes, organisation, h ...

Proposed instructions for use or electronic instructions for use and labels.] (b) Dat ...

5.6.2 Review input: The input to management review shall include information on— (a) ...