Revised Pre Screening Checklist For Medical Devices & in Vitro Diagnostics Applications PDF

Central Drug Standard Control Organization
Directorate General of Health Services

Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
A.1. Pre-Screening checklist for acceptability of applications for Grant of Registration Certificate/Re-
Registration Certificate in Form-41 for Medical Devices
Name of the firm: _____________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S. Administrative/Legal /Technical Documents. Status

No. Please Pg. No. Annexure
Tick (√ )
PART -A
1. Covering Letter-Purpose should be clearly mentioned with Page No.
and Index.
2. Self-attested copy of authorization letter to the person issued by the
Director/Company Secretary/Partner of the Indian Agent firm
3. Duly filled and signed Application in Form-40
4. Fee in TR6 Challan of USD 1500 for each site and USD 1000 for
each product equivalent to INR in A/C Head “0210-Medical and
Public Health, 04-Public Health, 104-Fees and Fines
5. Apostilled Power of Attorney (Original) issued by the manufacturer
to Indian agent
6. Notarized copy of valid Wholesale Licence or Manufacturing
Licence of the Indian Agent
7. Schedule DI & Undertaking duly filled, signed, stamped & dated
with name & designation of the manufacturer/Indian agent.
8. Schedule DII duly filled, signed, stamped & dated with name &
designation of the manufacturer/Indian agent.
9 Regulatory Certificates :
9.1 Duly apostilled/notarized copy of Free Sale Certificate/Marketing
Authorization of the product from National Regulatory Authority of
country of origin (if any)
9.2 Duly apostilled/notarized copy of Free Sale Certificate Marketing
Authorization of the product from National Regulatory Authority of
any of the following countries viz USA, EU, Canada, Japan,
Australia.
10 Duly notarized valid copies of Quality Certificate in respect of the
legal and actual manufacturing site (s) (wherever applicable)
(a) Certificate supporting Quality Management System
(b) Full Quality Assurance Certificate / CE Type Examination
Certificate/ CE Product Quality Assurance
(c) CE Design Certificate
(d) Declaration of Conformity.
11 Notarized IFU, Pack Insert of the applied devices.
12 Notarized Labels of the device as per Rule 109 A of D&C Rules.
Part- B
13  Notarized Plant Master file from the Manufacturer
 Duly notarized undertaking from the manufacturer for no
change in Plant Master File (in case of re-registration)
14  Notarized Device Master file from the Manufacturer
 Duly notarized undertaking from the manufacturer for no

change in Device Master File (In case of re-registration)
17 Notarized Undertaking regarding complaints received w.r.t “Not of
Standard Quality” of the proposed products during last three years
(In case of re-registration)
18 Duly notarized PMS Study Report for last three years
18.1 Detail of AEs/SAEs/Death/Recall/complaints of the proposed
products reported globally along with protocol for investigation of
root cause and CAPA taken by the manufacturer (if any)
18.2 Detail of AEs/SAEs/Death/Recall/complaints of the proposed
products during the last three years in India along with protocol for
investigation of root cause and CAPA taken by the manufacturer (if
any)
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:
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Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
A.2. Pre-Screening checklist for acceptability of applications for Grant of Import License in Form-10 for
notified medical devices /In-vitro Diagnostics

Tick(√ )
1. Covering Letter-Purpose should be clearly mentioned with
page number and Index.
2. Self-attested copy of authorization letter to the person
issued by the Director/Company Secretary/Partner of the
Indian Agent firm
3. Form-8 duly Signed & Stamped by applicant along with
name & designation of the Authorized Signatory
4. Form-9 duly Signed & Stamped by Indian Agent along
with name & designation of the Authorized Signatory or
duly appostilled/ notarized if signed & stamped by the
Manufacturer
5. Notarized copy of Wholesale Licence or Manufacturing
6. Original T/R Challan for Requisite Fee Rs.1000 for One
Proposed Device and Rs.100 for each additional Device in
A/C Head “0210-Medical and Public Health, 04-Public
Health, 104-Fees and Fines
7. Copy of Registration Certificate in form-41
8. Documents as stated in Registration Certificate (In case of
conditional certificate)
10. Notarized Labels of the device as per Rule 109 A of Drugs
& Cosmetics Rules).

Mobile No. :……..………………………….
E-mail:……………………………………
Office Use Only:
------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….……………
A.3. Pre-Screening checklist for acceptability of applications for Grant of Test License in Form-11 for
small quantity of medical devices
Name of the firm: _____________________________________ Date: ______________

No. Please Pg. No. Annexures
Tick(√ )
1. Covering Letter clearly mentioning the type of test to be
performed by using the proposed products- Purpose
should be clearly mentioned with page number and Index.
Indian Agent firm
3. Duly filled Form-12 Signed & Stamped by the authorized
signatory of the Applicant, mentioning the name &
address of the manufacturer, name and address of the
testing places and. Name of the product and pack size
(number of test per pack) , as per Drugs And Cosmetic
Acts And Rules
4. TR-6 Challan, Fee paid Total Amount (Rs.100 for One
product and Rs.50 for each additional product) in A/C
Head “0210-Medical and Public Health, 04-Public Health,
104-Fees and Fines
5. Utilization breakup along with Justification for the
proposed quantity of each of the product
6. Product Inserts, Label of the proposed product
7. Testing protocol of the proposed product (if any)
8. Valid copy of manufacturing license/wholesale license(if
any)
9. Undertaking stating that the proposed kits are Not For
Commercial Purpose

Mobile No. :……..…………………………….

E-mail:…………………………………………
Office Use Only:
------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….
A.4. Pre-Screening checklist for acceptability of applications for application

pertaining to grant of permission to import or manufacture new medical device
going to be introduced for the first time in the country for sale or to undertake
clinical trials

No. Please Pg. No. Annexures
Tick(√ )
1 Self-attested copy of authorization letter to the person issued
by the Director/Company Secretary/Partner of the Indian Agent
firm
2. Covering Letter:Application for permission to import or
manufacture new drugs for sale or to undertake clinical trials-
Purpose should be clearly mentioned with page numbers and
index
3. Application in Form 44 should be complete in all respect and
signed& stamped by the authorized person of the firm with
name and designation.
4. Treasury Challan of Rs.50,000/- / 15,000/- and should mention
the name of the New Device in A/C Head “0210-Medical and
5. Protocol:
the contents of Protocol should be as follows:
i. Title page
ii. Table of content
iii. Study Objective(s) (primary as well as secondary) and their
logical relation to the study design
iv. Study design
v. Study population
vi. Subject Eligibility- Inclusion Criteria and Exclusion Criteria
vii. Study Assessment
viii. Study Treatment
ix. Adverse Events
x. Ethical Consideration
xi. Study Monitoring and Supervision
xii. Investigational Product Management
xiii. Data Analysis
6. Undertaking by the Investigator: This shall include all the
details / elements as mentioned in the Appendix VII of
Schedule-Y.
7. Informed consent documents (patient information sheet,
informed consent form etc.) as per Appendix V of Schedule-Y
should mention the following: “In case of study related injury
or death M/s. (NAME OF THE COMPANY) will provide
complete medical care along with compensation for the injury

or death”
8. Case Record Form
9. Justification for conducting the study in India
Type of Study:
a. Feasibility
b. Pilot Study
c. Pivotal Study
10. Details of Pre Clinical Study
11. Details of Previous Clinical Study conducted pertaining to said
product in other countries
12. Published Literature Review / Clinical Evaluation Reports
13. Protocol Approval Status of the proposed study in GHTF and
other participating Countries, if any
14. Ethics Committee approvals if available
(Ethics Committee should be of same area where the site is
located).
15. Investigators Brochure
16. Technical Documents:-Specimen Copy of Labels, IFU’s

&Package Insert:- (if the device is marketed in any country)

Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:

------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….
A.5. Pre-Screening checklist for acceptability of applications for Extension in shelf life of the already
Registered Product
S. No. Administrative/Legal Documents. Status
Please Pg. No. Annexure

Tick(√ )
1 Covering Letter-Purpose should be clearly mentioned with page

number and Index.
2. Self-attested copy of authorization letter to the person issued by
the Director/Company Secretary/Partner of the Indian Agent
firm
3. Copy of Registration certificate mentioning the name of the
product along with approved shelf life of the devices.
4 Certificate of Approval of extension in shelf life issued by
National Regulatory Authority in country of origin.
(In case where formal approvals are not provided by NRA,

Letter submitted to inform NRA/ notified body)
5. List of the countries where product with proposed extension in

shelf life approved along with regulatory documents.
6. Stability Data including Stability protocol (Accelerated or Real
Time) stability test reports as per extension in shelf life
proposed.

Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:

------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….
A.6. Pre-Screening checklist for acceptability of applications for Additional Indication of the
already Registered Product

Tick(√ )
1. Covering Letter-Purpose should be clearly mentioned with page

number and Index.
2. Self-attested copy of authorization letter to the person issued by

the Director/Company Secretary/Partner of the Indian Agent
firm
3. Copy of Registration certificate mentioning the name of the
product along with indication approved earlier
4. Certificate of Approval of additional indication issued by
National Regulatory Authority in country of origin
5. Published data/detail of the study carried out for the additional
indication
6. List of the countries where product with additional indication
approved along with regulatory documents
7. Notarized revised and existing IFU’s/Package Inserts in respect
of additional indication of the proposed product

Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:

------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….
A.7. Pre-Screening checklist for acceptability of applications for further Clarification in respect of the
Product
Name of the firm:____________________________ Date: __________

Tick(√ )
1. Covering Letter-Purpose should be clearly mentioned

with page number and Index.
Indian Agent firm
3. Detail Product description along with material of
construction, intended use, Product specification, product
literature, package inserts alongwith a sample
4. Regulatory status of the said product in country of origin
5. Regulatory certificates in respect of said product

Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:

------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….
B.1. Pre Screening checklist for acceptability of applications for Grant of Registration Certificate/Re-
Registration Certificate of Notified in vitro Diagnostic Kits/Reagents in Form 41
Name of the firm: ___________________________________ Date: _______________

No. Please Tick Pg. No. Annexure
(√ )
PART –A
1. Covering Letter-Purpose should be clearly mentioned with Page No.
and Index.
3. Duly filled and signed Application in Form-40
4. Fee in TR6 Challan of USD 1500 for each site and USD 1000 for
each product equivalent to INR in A/C Head “0210-Medical and
5. Apostilled Power of Attorney (Original) issued by the manufacturer
to Indian agent
6. Notarized copy of valid Wholesale Licence or Manufacturing
7. Schedule DI & Undertaking duly filled, signed, stamped & dated
with name & designation of the manufacturer/Indian agent.
8. Schedule DII duly filled, signed, stamped & dated with name &
designation of the manufacturer/Indian agent.
9 Regulatory Certificates :
9.1 Duly Apostilled/notarized copy of Free Sale Certificate/Marketing
Authorisation of the product from National Regulatory Authority of
country of origin (if any).
9.2 Duly Apostilled/notarized copy of Free Sale Certificate Marketing
Authorisation of the product from National Regulatory Authority of
any of the following countries viz USA, EU, Canada, Japan,
Australia.
10 Duly Apostilled/notarized valid copies of Quality Certificate in
respect of the legal and actual manufacturing site (s) (wherever
applicable)
(e) Certificate supporting Quality Management System
(f) Full Quality Assurance Certificate /CE Production Quality
Assurance Certificate/ CE Type Examination Certificate/
CE Product Quality Assurance
(g) CE Design Certificate
(h) Declaration of Conformity.
11 Notarized IFU, Pack Insert of the applied devices.
12 Notarized Labels as per Rule 109 A of Drugs & Cosmetics Rules
13. Performance Evaluation Report of Products (HIV, HCV, HBV &

Blood grouping sera) from NIB, Noida for three consecutive
batches. If NIB do not have facility for testing , PER from other
institution will be accepted.
Part- B
14 Notarized Plant Master file from the Manufacturer
Notarized undertaking from the manufacturer for no change
in Plant Master File (in case of re-registration)
15.  Notarized Device Master file from the Manufacturer
 Notarized undertaking from the manufacturer for no change
in Device Master File (In case of re-registration)
16. The report of evaluation in details conducted by National Control
Authority of the country of origin.
17. Information as per Annexure B(HIV, HCV, HBV & Blood
Grouping Sera) of Schedule DII
20. Notarized Undertaking regarding complaints received w.r.t “Not of
Standard Quality” of the proposed products during last three years
21. Duly notarized PMS Study Report for last three years
21.1 Detail of AEs/SAEs/Recall/complaints of the proposed products
reported globally along with protocol for investigation of root cause
and CAPA taken by the manufacturer (if any)
21.2 Detail of AEs/SAEs/Recall/complaints of the proposed products
during the last three years in India along with protocol for
investigation of root cause and CAPA taken by the manufacturer (if
any)

Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:

------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….
B.2. Pre-Screening checklist for acceptability of applications for Grant of Import License in Form-10
for Non-notified in vitro Diagnostic Kits.

Tick(√ )
1. Self-attested copy of Authorization Letter issued by the
revealing the name and designation of the person authorized
to sign (along with the name and address of the firm) legal
documents such as Form 8, Form 9 etc.)
2. Form-8 duly Signed & Stamped by applicant along with
name & designation of the Authorized Signatory
3. Form-9 duly Signed & Stamped by Indian Agent along with
name & designation of the Authorized Signatory or duly, if
signed & stamped by the Manufacturer
4. Notarized & copy of Wholesale Licence or Manufacturing
5. Original T/R Challan for Requisite Fee Rs.1000 for One
Proposed Device and Rs.100 for each additional Device in
A/C Head “0210-Medical and Public Health, 04-Public
Health, 104-Fees and Fines
6. Regulatory Certificates :
6.1 Duly Apostilled/notarized copy of Free Sale
Certificate/Marketing Authorization of the product from
National Regulatory Authority of country of origin
or
Duly Apostilled/notarized copy of Free Sale Certificate
Marketing Authorization of the product from National
Regulatory Authority of any of the following countries viz
USA, EU, Canada, Japan, Australia.
6.2 Duly Apostilled/notarized valid copies of Quality Certificate
in respect of the legal and actual manufacturing site (s)
(wherever applicable)
(a) Certificate supporting Quality Management System
(b) Full Quality Assurance Certificate /CE Production
Quality Assurance Certificate/ CE Type Examination
Certificate/ CE Product Quality Assurance
(c) CE Design Certificate
(d) Declaration of Conformity.
7. Duly notarized, from country of origin, copy of Quality
Management System Certificates in respect of Actual
manufacturer.
8. Performance Evaluation Reports (PER) from NABL

approved laboratory for 3 batches for products intended for

Malaria, Tuberculosis, Dengue, Chikungunya, Syphilis,
Typhoid and Cancer markers.
9. In case of Blood Glucose test strips, PER from NIB, NOIDA.

If NIB do not have facility for testing, PER from other
institution will be accepted.
10. NOC from Department of Animal Husbandry, Ministry of

Agriculture, In Case of Veterinary IVD Kits
11. NOC from Bhabha Atomic Research Centre (BARC),

Mumbai, In case Radio Immuno Assay Kits
12. NOC from DG, ICMR, In case of influenza Kit
13. Notarized Copies of :

i) Product inserts,
ii) Labels as per Rule 109A,
iii) Certificate of analysis (COA) for the proposed
products.
14. A Copy of import License in form-10 (if the application is for

renewal/ Endorsement)
15. Soft copy of product list along with specific intended uses
(Word format).
16. Correlation chart with respect to products list mentioned in

Form 8, Form 9 and FSC submitted

Mobile No. :……..………………………….
E-mail:………………………………………
Office Use Only:

------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….
B.3. Pre-Screening checklist for acceptability of applications for Grant of Test License in Form-11 for in-
vitro diagnostic Kits/reagents:

Tick(√ )
1. Covering Letter-Purpose should be clearly mentioned with page
number and Index.
3. Form-12 duly Signed & Stamped by the authorized signatory of the
Applicant, mentioning the name & address of the manufacturer,
name and address of the testing places and. Name of the product
and pack size
4. TR-6 Challan, Fee paid Total Amount(Rs.100 for One product and
Rs.50 for each additional product)
5. Utilization breakup along with Justification for the proposed
quantity of each of the product
6. Copy of Product Insert or Label of the proposed product
7. Testing protocol of the proposed product (if any)
8. Valid copy of manufacturing license/wholesale license(if any)
9. Undertaking stating that the proposed kits are Not For Commercial
Purpose
10. Valid Copy of NABL accreditation certificate of testing
laboratory(wherever applicable)
Mailing Address of the applicant : Stamp & Signature of the

Mobile No. :……..………………………….
E-mail:………………………………………
Office Use Only:

------------------------------------------------------------------------------------------------
Signature: …………………………..
Date:…………….…………….

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Central Drug Standard Control Organization

Directorate General of Health Services

Name of the firm: _____________________________________ Date: _______________

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. Administrative/Legal /Technical Documents. Status

 Duly notarized undertaking from the manufacturer for no

Name of the firm: _____________________________________ Date: _______________

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. Administrative/Legal /Technical Documents. Status

Stamp & Signature of the

Mobile No. :……..………………………….

Name of the firm: _____________________________________ Date: ______________

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. Administrative/Legal /Technical Documents. Status

Stamp & Signature of the

Mobile No. :……..…………………………….

A.4. Pre-Screening checklist for acceptability of applications for application

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. Administrative/Legal /Technical Documents. Status

complete medical care along with compensation for the injury

16. Technical Documents:-Specimen Copy of Labels, IFU’s

Mailing Address of the applicant :

Mobile No. :……..…………………………….

Office Use Only:

Name of the Reviewer:….……………………….

Name of the firm: _____________________________________ Date: _______________

S. No. Administrative/Legal Documents. Status

Please Pg. No. Annexure

1 Covering Letter-Purpose should be clearly mentioned with page

(In case where formal approvals are not provided by NRA,

5. List of the countries where product with proposed extension in

Mailing Address of the applicant :

Mobile No. :……..…………………………….

Office Use Only:

Name of the Reviewer:….……………………….

Name of the firm: _____________________________________ Date: _______________

S. No. Administrative/Legal Documents. Status

Please Pg. No. Annexure

1. Covering Letter-Purpose should be clearly mentioned with page

2. Self-attested copy of authorization letter to the person issued by

Mailing Address of the applicant :

Mobile No. :……..…………………………….

Office Use Only:

Name of the firm:____________________________ Date: __________

S. No. Administrative/Legal Documents. Status

Please Pg. No. Annexure

1. Covering Letter-Purpose should be clearly mentioned

5. Regulatory certificates in respect of said product

Mailing Address of the applicant :

Mobile No. :……..…………………………….

Office Use Only:

Name of the firm: ___________________________________ Date: _______________

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. Administrative/Legal /Technical Documents. Status

13. Performance Evaluation Report of Products (HIV, HCV, HBV &

Stamp & Signature of the

Office Use Only:

Name of the Reviewer:….……………………….

Name of the firm: ___________________________________ Date: _______________

Name of the firm: _______________________ Date: _

TR-6 Challan No:________Date:_Ref: No:___________

Name of the firm: _______________________ Date: _

TR-6 Challan No:________Date:_Ref: No:___________

Name of the firm: _______________________ Date:

TR-6 Challan No:________Date:_Ref: No:___________

TR-6 Challan No:________Date:_Ref: No:___________

Name of the firm: _______________________ Date: _

Name of the firm: _______________________ Date: _

Name of the firm:__________________ Date:

Name of the firm: _____________________ Date: _

TR-6 Challan No:________Date:_Ref: No:___________

Name of the firm: _____________________ Date: _

TR-6 Challan No:________Date:_Ref: No:___________

Name of the firm: _____________________ Date: _

TR-6 Challan No:________Date:_Ref: No:___________