Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device Division)
A.1 Checklist for Pre Screening of Applications for Grant of Registration Certificate/ReRegistration Certificate in Form-41 for Medical Devices
Name of the firm: _____________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
1.
Covering Letter-Purpose should be clearly mentioned with page
number and Index.
Authorization Letter in original issued by the Director/Company
Secretary/Partner of the Indian Agent firm revealing the name
and designation of the person authorised to sign (along with the
name and address of the firm) legal documents such as Form
40, POA etc.)
Application in Form-40
2.
3.
3.1
3.2
3.3
3.4
4.
Please Pg. No.
Tick(√ )


Duly signed & stamped by the Applicant
Name of the Medical Device(s) to be registered along
with Brand Name, Generic Name, Intended Use, Shelf
Life etc.
 Name &Full Address of Authorized Agent in India
 Names & Full Address of Manufacturer & its Factory
Premises
TR6 Challan
4.1

4.2

4.3
4.4
5.
5.1
5.2
5.3
Fees paid
Total USD………….Equivalent to………………INR
( _________ for site &_________for product)
Head to Fees Deposited (“0210-Medical and Public
Health, 04-Public Health, 104-Fees and Fines)
 Should indicate the name and address of the premises
to be registered
 Realisation Stamp
Power of Attorney(Original)
 Authenticated either in India before a First class
Magistrate, or in the country of origin before such an
equivalent authority, the certificate of which is attested
by the Indian Embassy of the said country (original copy)
or Apostilled Power of Attorney from Hague convention
member countries
 Name & Full Address of the manufacturer & its
manufacturing site (in line of clause 3.4)
 Name and full address of the Indian Agent
5.4

5.5

6.
Status
Name of the Proposed Products(in line of clause 3.2)
Duly signed, dated with name & designation of the
signatory by both Indian agent & the manufacturer
Duly notarized Copy of valid Wholesale Licence
or
Manufacturing Licence of the Indian Agent
Annexure
7.
8.
9
9.1
9.2
10
10.1
11
12
Dully filled Schedule DI &Undertaking duly signed, stamped &
dated with name & designation of the manufacturer.
Dully filled Schedule DII &Undertaking signed, stamped & dated
with name & designation of the manufacturer.
Regulatory Certificates :
Duly Apostilled/notarized and authenticated by Indian Embassy
in the country of origin and) copy of Free Sale Certificate from
National Regulatory Authority of country of origin specifying
name and address of legal and actual manufacturing site along
with applied product name in generic name and model name (if
any)
Duly Apostilled/notarized and authenticated by Indian Embassy
in the country of origin and) copy of Free Sale Certificate from
National Regulatory Authority of any one of the following
countries viz USA, EU, Canada, Japan, Australia
Quality Certificates :
Duly Apostilled/notarized and authenticated by Indian Embassy
in the country of origin) & Valid Copies of Quality Certificate in
respect of the legal and actual manufacturing site (s).
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality
Assurance Certificate/ CE Type Examination Certificate/ CE
Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
Notarized Plant Master file from country of origin including the
following information:
 Layout of premises, Manufacturing activities, Total
employees and Organisation chart
 Plant registration certificate/ approval certificate issued
by NRA
 Brief information on the site relation to other sites etc
 Brief description of major production and quality control
laboratories equipment
 Location & layout plan of premises
 Flow chart. Brief details of manufacture process, quality
control system
 System of conformity document followed by manufacture
Notarized Device Master file from country of origin including
the following information:

13
Device Description, Product Specification & flow chart of
the manufacturing process of the device
 Comparative chart of the proposed product along with
similar product approved in India
 Quality Control Reports in respect of raw materials &
finished products, sterilization reports etc.
 Clinical trial data/Published data.
 Biocompatibility Reports, Physiochemical testing reports
 Test specifications & method of testing
 Batch Release Certificates and Certificate of Analysis of
finished product for minimum 3 batches
 Risk Management Report and Essential Principle
Checklist
 Original label and Draft label,
 Stability data both for Accelerated & Real time.
 Packaging & Instruction For Use.
Duly notarized undertaking from the manufacturer for no change
in Device Master File and Plant Master File (For Re registration
14
15
16
16.1
16.2
only) along with Soft copy of PMF and DMF
Undertaking for Sale details of the proposed products during
last three years in India (For Re registration only )
Notarized Undertaking regarding complaints received w.r.t “Not
of Standard Quality” of the proposed products during last three
years (For Re registration only)
Duly notarized PMS Study Report
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)
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) (For Re registration only)
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device, Diagnostic Division)
A.2. Checklist for Pre Screening of Applications for Grant of Import License in Form-10 for
medical devices
Name of the firm: _____________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
Status
Please
Tick(√ )
1. Covering Letter-Purpose should be clearly mentioned
with page number and Index.
2. Authorization
Letter
in
original
issued
by
the
Pg. No.
Annexure
Director/Company Secretary/Partner of the Indian
Agent firm 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.)
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
Manufacturing Licence of the Indian Agent
or
6. Requisite Fee Rs.1000 for One Proposed Device and
Rs.100 for each additional Device total amount paid
6.1 Fees paid
Total :INR ____________for ________products
6.2 Head to Fees Deposited (“0210-Medical and Public
Health, 04-Public Health, 104-Fees and Fines)
6.3 Should indicate the name and address of the
premises to be registered
6.4 Realisation Stamp
7. Copy of Registration Certificate in form-41
8. A Copy of import License in form-10 (if the application
is for renewal/ Endorsement)
9. Documents as stated in Registration Certificate (In
case of conditional certificate)
10.
Labels as per Rule 96 (if applicant is other than the
Principal Indian Agent)
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..………………………….
E-mail:……………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device & Diagnostic Division)
A.3 Checklist for Pre Screening of Applications for Grant of Test License in Form-11 for
small quantity of medical devices
Name of the firm: _____________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
Status
Please
Tick(√ )
Pg. No.
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.
2. 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 (number of test per pack) , as per Drugs And
Cosmetic Acts And Rules
3. TR-6 Challan, Fee paid Total Amount(Rs.100 for One product and
Rs.50 for each additional product)
4. Utilization breakup along with Justification for the proposed quantity
of each of the product
5. Product Inserts, Label of the proposed product
6. Testing protocol of the proposed product (if any)
7. Valid copy of manufacturing license/wholesale license(if any)
8. Undertaking stating that the proposed kits areNot For Commercial
Purpose
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
A.4 CHECKLIST FOR ACCEPTABILITY OF APPLICATION PERTANING 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
Name of the firm: _____________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
1.
Whether proposed device is notified Medical Device under Drugs
and Cosmetics Act & Rules
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
Application in Form 44 should be complete in all respect and
signed& stamped by the authorized person of the firm with name and
designation. It should include following information:
a. Name of the Applicant
b. Name of the Medical Device
c. Composition/Accessories
d. Intended Use etc.
3.
4.
5.
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
xii.
xiii.
6.
7.
8.
9.
Treasury Challan of Rs.50,000/- / 15,000/- and should mention the
name of the New Device including correct head of the account
payable at, bank clearance, etc
Protocol:
the contents of Protocol should be as follows:
Title page
Table of content
Study Objective(s) (primary as well as secondary) and their logical
relation to the study design
Study design
Study population
Subject Eligibility- Inclusion Criteria and Exclusion Criteria
Study Assessment
Study Treatment
Adverse Events
Ethical Consideration
Study Monitoring and Supervision
Investigational Product Management
Data Analysis
Undertaking by the Investigator: This shall include all the details /
elements as mentioned in the Appendix VII of Schedule-Y.
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”
Case Record Form
Justification for conducting the study in India
Type of Study:
a. Feasibility
b. Pilot Study
c. Pivotal Study
Status
Please
Pg. No.
Tick(√ )
10.
11.
12.
13.
14.
15.
16.
Details of Pre Clinical Study
Details of Previous Clinical Study conducted pertaining to said
product in other countries
Published Literature Review / Clinical Evaluation Reports
Protocol Approval Status of the proposed study in GHTF and other
participating Countries, if any
Ethics Committee approvals if available
(Ethics Committee should be of same area where the site is located).
Investigators Brochure
Technical Documents:-Specimen Copy of Labels, IFU’s &Package
Insert:- (if the device is marketed in any country)
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
A.5 Checklist for Pre Screening of Applications for renewal of Registration Certificate in
Form-41 for Medical Devices
Name of the firm: _____________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
1.
Covering Letter-Purpose should be clearly mentioned with page
number and Index.
Authorization Letter in original issued by the Director/Company
Secretary/Partner of the Indian Agent firm revealing the name
and designation of the person authorised to sign (along with the
name and address of the firm) legal documents such as Form
40, POA etc.)
Application in Form-40
2.
3.
3.1
3.2
3.3
3.4
4.
Please Pg. No.
Tick(√ )


Duly signed & stamped by the Applicant
Name of the Medical Device(s) to be registered along
with Brand Name, Generic Name, Intended Use, Shelf
Life etc.
 Name &Full Address of Authorized Agent in India
 Names & Full Address of Manufacturer & its Factory
Premises
TR6 Challan
4.1

4.2

4.3
4.4
5.
5.1
5.2
5.3

5.5

7.
8.
9
Fees paid
Total USD………….Equivalent to………………INR
( _________ for site &_________for product)
Head to Fees Deposited (“0210-Medical and Public
Health, 04-Public Health, 104-Fees and Fines)
 Should indicate the name and address of the premises
to be registered
 Realisation Stamp
Power of Attorney(Original)
 Authenticated either in India before a First class
Magistrate, or in the country of origin before such an
equivalent authority, the certificate of which is attested
by the Indian Embassy of the said country (original copy)
or Apostilled Power of Attorney from Hague convention
member countries
 Name & Full Address of the manufacturer & its
manufacturing site (in line of clause 3.4)
 Name and full address of the Indian Agent
5.4
6.
Status
Name of the Proposed Products(in line of clause 3.2)
Duly signed, dated with name & designation of the
signatory by both Indian agent & the manufacturer
Duly notarized Copy of valid Wholesale Licence
or
Manufacturing Licence of the Indian Agent
Dully filled Schedule DI & Undertaking duly signed, stamped &
dated with name & designation of the manufacturer.
Dully filled Schedule DII & Undertaking signed, stamped &
dated with name & designation of the manufacturer.
Regulatory Certificates :
Annexure
9.1
9.2
10
10.1
11
12
13
14
14.1
14.2
Duly Apostilled/notarized and authenticated by Indian Embassy
in the country of origin and) copy of Free Sale Certificate from
National Regulatory Authority of country of origin specifying
name and address of legal and actual manufacturing site along
with applied product name in generic name and model name (if
any)
Duly Apostilled/notarized and authenticated by Indian Embassy
in the country of origin and) copy of Free Sale Certificate from
National Regulatory Authority of any one of the following
countries viz USA, EU, Canada, Japan, Australia
Quality Certificates :
Duly Apostilled/notarized and authenticated by Indian Embassy
in the country of origin) & Valid Copies of Quality Certificate in
respect of the legal and actual manufacturing site (s).
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality
Assurance Certificate/ CE Type Examination Certificate/ CE
Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
Duly notarized undertaking from the manufacturer for no change
in Device Master File and Plant Master File alongwith Soft copy
of Device Master File and Plant Master File
Undertaking for Sale details of the proposed products during
last three years in India.
Notarized Undertaking regarding complaints received w.r.t “Not
of Standard Quality” of the proposed products during last three
years
Duly notarized PMS Study Report
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)
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:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device & Diagnostics Division)
A.6 Pre- screening checklist for Extension in shelf life of the already Registered Product
Name of the firm: _____________________________________
_______________
S. No.
Administrative/Legal Documents.
Date:
Status
Please Pg. No.
Tick(√ )
Annexure
Covering Letter-Purpose should be clearly mentioned with
page number and Index.
Copy of Registration certificate mentioning the name of
the product along with approved shelf life of the devices
Certificate of Approval of extension in shelf life issued by
National Regulatory Authority in country of origin
Stability Data including Stability protocol and real time as
well as accelerated stability test reports as per extension
in shelf life proposed
List of the countries where product with proposed
extension in shelf life approved along with regulatory
documents
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device & Diagnostics Division)
A.7 Checklist for Pre Screening of Applications for Additional Indication of the already
Registered Product
Name of the firm: _____________________________________
_______________
S. No.
Administrative/Legal Documents.
Date:
Status
Please Pg. No.
Tick(√ )
Annexure
Covering Letter-Purpose should be clearly mentioned with
page number and Index.
Copy of Registration certificate mentioning the name of
the product along with indication approved earlier
Certificate of Approval of additional indication issued by
National Regulatory Authority in country of origin
Published data/detail of the study carried out for the
additional indication
List of the countries where product with additional
indication approved along with regulatory documents
Revised and original IFU’s in respect of additional
indication of the proposed product
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device Division)
A.8 Checklist for Pre Screening of Applications for Further Clarification in respect of the
Product
Name of the firm:____________________________
S. No.
Date: __________
Administrative/Legal Documents.
Status
Please
Tick(√ )
1.
2.
3.
4.
Pg.
No.
Annexure
Covering Letter-Purpose should be clearly mentioned
with page number and Index.
Detail Product description along with material of
construction, intended use, Product specification, product
literature, package inserts
Regulatory status of the said product in country of origin
Regulatory certificates in respect of said product
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..…………………………….
E-mail:…………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device &Diagnostic Division)
B.1. Checklist for Pre Screening of Applications for Grant of Registration Certificate/Reregistration to Notified in vitro Diagnostic Kits/Reagents in Form 41
Name of the firm: ___________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
1.
Covering Letter-Purpose should be clearly mentioned with
page number and Index.
Authorization
Letter
in
original
issued
by
the
Director/Company Secretary/Partner of the Indian Agent firm
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 40, POA etc.)
2.
3.
3.1
3.2
3.3
3.4
4.
4.1
4.2
4.3
4.4
5.
Status
Please Pg. No.
Tick(√ )
Application in Form-40


Duly signed & stamped by the Applicant
Name of the Medical Device(s) to be registered along
with Brand Name, Generic Name, Intended Use,
Shelf Life etc.
 Name & Full Address of Authorized Agent in India
 Names & Full Address of Manufacturer & its Factory
Premises
TR6 Challan

Fees paid
Total USD………….Equivalent to………………INR(
_________ for site &_________for product)
 Head to Fees Deposited (“0210-Medical and Public
Health, 04-Public Health, 104-Fees and Fines)
 Should indicate the name and address of the
premises to be registered
 Realization Stamp
Power of Attorney(Original)
5.1

5.2

5.3

Authenticated either in India before a First class
Magistrate, or in the country of origin before such an
equivalent authority, the certificate of which is attested
by the Indian Embassy of the said country (original
copy) or Apostille Power of Attorney from Hague
convention member countries
Name & Full Address of the manufacturer & its
manufacturing site (in line of clause 3.4)
Name and full address of the Indian Agent
5.4

Name of the Proposed Products(in line of clause 3.2)
5.5

Duly signed, dated with name & designation of the
signatory by both Indian agent & the manufacturer
Annexure
6.
Duly notarized Copy of valid Wholesale Licence
Manufacturing Licence of the Indian Agent
7.
Dully filled Schedule DI &Undertaking duly signed, stamped
& dated with name & designation of the manufacturer.
8.
Dully filled Schedule DII along with Undertaking signed,
stamped & dated with name & designation of the
manufacturer.
8.1
Information as per Annexure B(HIV, HCV, HBV & Blood
Grouping Sera) of Schedule DII
9
Regulatory Certificates :
9.1
Duly Apostilled/notarized and authenticatedby Indian
Embassy in the country of origin) & Valid Copies of Quality
Certificatein respect of the legal and actual manufacturing
site (s).
9.2
or
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality
Assurance Certificate/ CE Type Examination Certificate/
CE Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
Duly Apostilled/notarized and authenticated by Indian
Embassy in the country of origin and) copy of Free Sale
Certificate from National Regulatory Authority of any one of
the following countries viz USA, EU, Canada, Japan,
Australia
10
Quality Certificates :
10.1
Duly Apostilled/notarized and authenticated by Indian
Embassy in the country of origin) & Valid Copies of Quality
Certificate in respect of the legal and actual manufacturing
site (s).
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality
Assurance Certificate/ CE Type Examination Certificate/ CE
Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
Notarized Plant Master file from country of origin including
the following information:
 Layout of premises, Manufacturing activities, Total
employees and Organisation chart
 Plant registration certificate/ approval certificate
issued by NRA
 Brief information on the site relation to other sites etc
 Brief description of major production and quality
control laboratories equipment
 Location & layout plan of premises
 Flow chart. Brief details of manufacture process,
quality control system
 System of conformity document followed by
manufacture
11
12
Notarized Device Master file from country of origin including
the following information:











Device Description, Product Specification & flow chart
of the manufacturing process of the device
Comparative chart of the proposed product along with
similar product approved in India
Quality Control Reports in respect of raw materials &
finished products, sterilization reports etc.
Clinical trial data/Published data.
Biocompatibility Reports, Physiochemical testing
reports
Test specifications & method of testing
Batch Release Certificates and Certificate of Analysis
of finished product for minimum 3 batches
Risk Management Report and Essential Principle
Checklist
Original label and Draft label,
Stability data both for Accelerated & Real time.
Packaging & Instruction for Use.
13
Duly notarized undertaking from the manufacturer for no
change in Device Master File and Plant Master File (For Re
registration only) along with Soft copy of PMF and DMF
14
Performance Evaluation Report of Products (HIV, HCV, HBV
& Blood grouping sera) from NIB, Noida for three consecutive
batches.
15
Undertaking for Sale details of the proposed products during
last three years in India (For Re registration only )
16
Notarized Undertaking regarding complaints received w.r.t
“Not of Standard Quality” of the proposed products during
last three years (For Re registration only)
17
Duly notarized PMS Study Report
17.1
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)
17.2
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) (For Re registration only)
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..………………………….
E-mail:………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device&Diagnostic Division)
B.2. Checklist for Pre Screening of Applications for Grant of Import License in Form-10
Notified Diagnostic Kits.
Name of the firm: ___________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
Status
Please Pg. No.
Tick(√ )
10. Authorization Letter in original issued by the
Director/Company Secretary/Partner of the Indian
Agent firm 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.)
11. Form-8 duly Signed & Stamped by applicant along with
name & designation of the Authorized Signatory
12. Form-9 duly Signed & Stamped by Indian Agent along
with name & designation of the Authorized Signatory or
duly, if signed & stamped by the Manufacturer
13. Notarized & copy of Wholesale Licence
Manufacturing Licence of the Indian Agent
or
14. Requisite Fee Rs.1000 for One Proposed Device and
Rs.100 for each additional Device total amount paid
6. Fees paid
Total INR PAID _____________
6.1 Head to Fees Deposited (“0210-Medical and Public
Health, 04-Public Health, 104-Fees and Fines)
6.2 Should indicate the name and address of the premises
to be registered
6.3 Realization Stamp
7. Copy of Registration Certificate in form-41
8.
A Copy of import License in form-10 (if the application is
for renewal/ Endorsement)
9.
Documents as stated in Registration Certificate (In case
of conditional certificate)
10.
Labels as per Rule 96 if applicant is other than the
Principal Indian Agent
Annexure
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..………………………….
E-mail:………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device & Diagnostic Division)
B.4. Checklist for Pre-screening of Applications for Grant of Import license in Form 10 for
Non-Notified in-vitro diagnostic Kits/reagents:
Name of the firm: ___________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
Status
Please
Tick(√ )
1.
Covering Letter-Purpose should be clearly mentioned with
page number and Index.
2. Authorization letter in original issued by the
Director/Company Secretary/Partner of the Indian Agent
firm revealing the name & designation of the person
authorized to sign (along with the name and address of the
firm) legal documents such as Form 8 and Form 9
3. Form-8 and product list along with specific intended uses,
duly signed and stamped by the Indian agent along with
name and designation of authorized signatory(with full
address) indicating the Generic name and Brand name (if
any) and specific intended use as mentioned in package
Insert in not more than 40 words for each proposed
product . If the firm intends to import product in Bulk it
should be mentioned in Form 8 product list wherever
applicable.
4. Duly notarized Form 9 duly signed and stamped by the
authorized signatory of manufacturer (with full address)
from country of origin indicating the Generic name and
Brand name (if any) and specific intended use as
mentioned in package Insert in not more than 40 words for
each proposed product. If the firm intends to import
product in Bulk it should be mentioned in Form 9 product
list wherever applicable.
5. Requisite Fee Rs 1000/- for one proposed product and Rs.
100/- for each additional product. Applicant is required to
submit separate fee for each type of product viz. test
strip/cassettes/midstream, etc which the firm intent to
import
6. Duly notarized copy of Free Sale Certificate/Certificate to
Foreign Government/ Certificate of Marketability issued by
National Regulatory Authority from country of origin
mentioning name and address of both legal and actual
manufacturer.
7. Notarized copy of whole sale license or manufacturing
license in respect of Indian Agent/importer
8. Duly notarized, from country of origin, copy of ISO 13485
certificates in respect of Actual manufacturer.
9. ISO/ CE certificates (If any)
10. Original Performance Evaluation Reports (PER) from
National Accredited Labs of India for 3 batches for
products intended for Tuberculosis, Dengue, chikungunya,
Pg. No.
Annexure
Syphilis, Typhoid and Cancer markers.
11. In case of Malaria Kit, PER from any one of the following
Laboratory:
i)
NIB, Noida
ii)
NVBDCP,New Delhi
iii)
NIMR, Delhi
iv)
RMRCT,Jabalpur (M.P.)
12. NOC from Department of Animal
Husbandry, Ministry of Agriculture, In
Case of Veterinary IVD Kits
13. NOC from Bhabha Atomic Research Centre(BARC),
Mumbai, In case Radio Immuno Assay Kits
14. NOC from DG, ICMR, In case of influenza Kit
15.
i)
Product inserts,
ii)
Labels,
iii)
Certificate of analysis(COA) for the proposed
products
16. Soft copy of product list along with specific intended uses
(Word format).
17. Correlation chart w.r.t. products list mentioned in Form 8,
Form 9 and FSC submitted
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..………………………….
E-mail:………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device&Diagnostic Division)
B.3. Checklist for Pre Screening of Applications for Grant of Test License in Form-11 for
in-vitro diagnostic Kits/reagents:
Name of the firm: ___________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
Status
Please Pg. No.
Tick(√ )
Annexure
1. Covering Letter-Purpose should be clearly mentioned with
page number and Index.
2. 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
3. TR-6 Challan, Fee paid Total Amount(Rs.100 for One
product and Rs.50 for each additional product)
4. Utilization breakup along with Justification for the proposed
quantity of each of the product
5. Product Inserts, Label of the proposed product
6. Testing protocol of the proposed product (if any)
7. Valid copy of manufacturing license/wholesale license(if any)
8. Undertaking stating that the proposed kits are Not For
Commercial Purpose
9. Valid Copy of NABL accreditation certificate of testing
laboratory(wherever applicable)
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant
Mobile No. :……..………………………….
E-mail:………………………………………
Office Use Only:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:
Date:
Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device &Diagnostic Division)
B.4. Checklist for Pre Screening of Applications for approval of Re-registration to Notified
in vitro Diagnostic Kits/Reagents in Form 41
Name of the firm: ___________________________________ Date: _______________
TR-6 Challan No:________________Date:_______________Ref: No:_________________
S.
No.
Administrative/Legal /Technical Documents.
1.
Covering Letter-Purpose should be clearly mentioned with
page number and Index.
Authorization
Letter
in
original
issued
by
the
Director/Company Secretary/Partner of the Indian Agent firm
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 40, POA etc.)
2.
3.
3.1
3.2
3.3
3.4
4.
4.1
4.2
4.3
4.4
5.
Please Pg. No.
Tick(√ )
Application in Form-40


Duly signed & stamped by the Applicant
Name of the Medical Device(s) to be registered along
with Brand Name, Generic Name, Intended Use,
Shelf Life etc.
 Name & Full Address of Authorized Agent in India
 Names & Full Address of Manufacturer & its Factory
Premises
TR6 Challan

Fees paid
Total USD………….Equivalent to………………INR(
_________ for site &_________for product)
 Head to Fees Deposited (“0210-Medical and Public
Health, 04-Public Health, 104-Fees and Fines)
 Should indicate the name and address of the
premises to be registered
 Realization Stamp
Power of Attorney(Original)
5.1

5.2

5.3

Authenticated either in India before a First class
Magistrate, or in the country of origin before such an
equivalent authority, the certificate of which is attested
by the Indian Embassy of the said country (original
copy) or Apostille Power of Attorney from Hague
convention member countries
Name & Full Address of the manufacturer & its
manufacturing site (in line of clause 3.4)
Name and full address of the Indian Agent
5.4

Name of the Proposed Products(in line of clause 3.2)
5.5

6.
7.
Status
Duly signed, dated with name & designation of the
signatory by both Indian agent & the manufacturer
Duly notarized Copy of valid Wholesale Licence
or
Manufacturing Licence of the Indian Agent
Dully filled Schedule DI &Undertaking duly signed, stamped
& dated with name & designation of the manufacturer.
Annexure
8.
Dully filled Schedule DII along with Undertaking signed,
stamped & dated with name & designation of the
manufacturer.
8.1
Information as per Annexure B(HIV, HCV, HBV & Blood
Grouping Sera) of Schedule DII
9
Regulatory Certificates :
9.1
Duly Apostilled/notarized and authenticatedby Indian
Embassy in the country of origin) & Valid Copies of Quality
Certificatein respect of the legal and actual manufacturing
site (s).
9.2
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality
Assurance Certificate/ CE Type Examination Certificate/
CE Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
Duly Apostilled/notarized and authenticated by Indian
Embassy in the country of origin and) copy of Free Sale
Certificate from National Regulatory Authority of any one of
the following countries viz USA, EU, Canada, Japan,
Australia
10
Quality Certificates :
10.1
Duly Apostilled/notarized and authenticated by Indian
Embassy in the country of origin) & Valid Copies of Quality
Certificate in respect of the legal and actual manufacturing
site (s).
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality
Assurance Certificate/ CE Type Examination Certificate/ CE
Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
Duly notarized undertaking from the manufacturer for no
change in Device Master File and Plant Master along with
Soft copy of Device Master File and Plant Master File.
11.
12.
Performance Evaluation Report of Products (HIV, HCV, HBV
& Blood grouping sera) from NIB, Noida for three consecutive
batches.
13.
Undertaking for Sale details of the proposed products during
last three years in India
14.
Notarized Undertaking regarding complaints received w.r.t
“Not of Standard Quality” of the proposed products during
last three years
Duly notarized PMS Study Report
15.
16.1
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)
16.2
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:
-----------------------------------------------------------------------------------------------Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.
Signature: …………………………..
Name of the Reviewer:….……………………….
Date:…………….…………….