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

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

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

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

INFORMATION TO BE SUBMITTED ALONG WITH THE APPLICATION 1. Design Analysis data inclu ...

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

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 ...