2023-09-13T05:15:38
1.8 Domestic price of the device in the currency followed in the country of
origin.
1.9 List of regulatory approvals or marketing clearance obtained (submit
respective copies of approval Certificates):—
Country
Approved
Indication
Approved Shelf
life
Class of
Device
Date of First
Approval
USA
Australia
Japan
Canada
European
Union
Others*
* Optional
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 105 of 248
Status of market clearance pending, rejected or withdrawn
Regulatory Agency
of the country
Indication
for use
Registration
status and date
Reason for rejection/
withdrawal, if any
1.10 Safety and performance related information on the device:
(a) Summary of reportable event and field safety corrective action from the
date of introduction:—
For Serious Adverse Event:
SI.
No.
Serious Adverse
Event (SAE)
Duration Number of the SAE
reported
Total
Units sold
Lot/Batch
From To No.
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