2023-05-20T04:53:12
PART II
(i) Documents to be submitted with the application for grant of Import
Licence or licence to manufacture for sale or for distribution of a Class A
40[(other than non-sterile and non-measuring)] medical device
(a) The applicant shall submit documents as specified in the Table below:—
S.No. For medical devices other than in vitro
diagnostic medical device
For in vitro diagnostic medical
device
1.
device description, intended use of the
device, specification including variants and
accessories;
device description, intended use of
the device, specification including
variants and accessories;
2. material of construction; a summary of analytical technology,
relevant analytes and test procedure;
3. working principle and use of a novel
technology (if any);
working principle and use of a novel
technology (if any);
4.
labels, package inserts (41[instructions for
use or electronic instructions for use], etc.),
user manual, wherever applicable;
Labels and package inserts
(
42[instructions for use or electronic
instructions for use], etc.) , user
manual, wherever applicable;
5.
summary of any reported Serious Adverse
Event in India or in any of the countries
where device is marketed and action taken
by the manufacturer and National
Regulatory Authority concerned;
analytical performance summary
including sensitivity and specificity;
6. site or plant master file as specified in
Appendix I of this Schedule;
site or plant master file as specified
in Appendix I of this Schedule;
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 99 of 248
7. constitution details of the firm (of domestic
manufacturer or authorised agent);
constitution details of the firm (of
domestic manufacturer or authorised
agent);
8.
essential principles checklist for
demonstrating conformity to the essential
principles of safety and performance of the
medical device;
essential principles checklist for
demonstrating conformity to the
essential principles of safety and
performance of the in vitro medical
device;
9.
undertaking signed by the manufacturer
stating that the manufacturing site is in
compliance with the provisions of the Fifth
Schedule; undertaking signed by the
manufacturer stating that the
manufacturing site is in compliance
with the provisions of the Fifth
Schedule.
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