PART IV
INFORMATION REQUIRED TO BE SUBMITTED WITH THE
APPLICATION FORM FOR IMPORT OR MANUFACTURE OF
MEDICAL DEVICES WHICH DOES NOT HAVE PREDICATE
DEVICE
(a) Data to be submitted along with the application (for medical devices other than new in vitro diagnostic):—
1. Design Analysis data including, (whichever applicable)—
(a) design input and design output documents;
(b) mechanical and electrica ...
Accredited Consultants Pvt Ltd 2023-10-05T05:46:29 2023-10-05T05:46:29
Accredited Consultants Pvt Ltd 
PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANUFACTURE OF
