Application for Registration of Notified Diagnostics Kits in India

Module 3

Registration of Notified Diagnostics Kits in India

The following documents are required to be submitted in the following manner and order for the registration of the Notified Diagnostics Kits for import into India:-

Applicants are requested to submit following documents in 2 separate files as follows: –

1.Covering Letter – The covering letter is an important part of the application and should clearly specify the intent of the application (whether the application for the registration of the manufacturing site is being submitted for the first time, whether the application is for re-registration or is for the endorsement of additional products to an existing Registration Certificate) the list of documents that are being submitted (Index with page nos.) as well as any other important and relevant information may be provided in the covering letter. The covering letter should be duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory along with details like Fax No., Email Id

2. An Authorization letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm which contains the name & designation of the person authorized to sign legal documents such as Form 40, Power of Attorney etc. on behalf of the firm & should be submitted at the time of submission of the application for registration. Duly self-attested photocopies of the Authorization letter may be submitted at the time of submission of subsequent applications.

3. A duly filled Form 40 as per the Performa prescribed in the Drugs & Cosmetics Rules, signed & stamped by the Indian Agent along with name & designation. The name and address of the Indian Agent should be as given in the Drug Sale Licence in Form 20B & 21B or its renewal in Form 21C. Form 40 Performa is enclosed at Annexure – I.

4. The requisite fee as prescribed in the Drugs & Cosmetics Act & Rules viz. 1500 USD for the registration of the manufacturing premises and 1000 USD for a single Device and an additional fee at the rate of 1000 USD for each additional device proposed to be imported may be submitted at notified branches of Bank of Baroda under the Head of Account “0210 – Medical and Public Health, 04 – Public Health, 104 – Fees and Fines” adjustable to Pay and Account Officer, DGHS, New Delhi in the form of a Treasury Challan. Performa for Treasury Challan (TR 6) is given in Annexure – II. The Receipt in original (TR 6) is required to be submitted along with the application for registration. Applicants are advised to make sure that the TR6 Challan clearly indicates the USD equivalence of the amount paid in Indian Rupees.

In case of any direct payment of fee by the manufacturer in the country of origin, the fee shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the electronic code of the bank, under the head of Account stated above and the original receipt of the said transfer shall be treated as an equivalent to the Bank Challan, subject to the approval by the Bank of Baroda that they have received the payment.

Applicant is required to submit separate fee for each categories like test strip, cassettes, midstream, etc. which the firm intents to import/Register.

5. Power of Attorney – The authorization by a manufacturer to his agent in India shall be documented by a Power of Attorney executed and 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, and the original of the same shall be furnished along with the application for Registration Certificate. Apostille Power of Attorney from Hague convention member countries is also acceptable. Performa for Power of Attorney is given in Annexure III.

While submitting the Power of Attorney, the following points should be kept in mind:

  • It should be co-jointly signed and stamped by the manufacturer as well as the Indian Agent indicating the name & designation of the authorized signatories.
  • It should clearly list the names of all the proposed devices (including Model Nos, if applicable) along with their specific application and/or intended use. Further, the names of the proposed devices should correlate with those mentioned in the Form 40 and Free Sale Certificate to be submitted.
  • The names & addresses of the manufacturer as well as the Indian Agent stated in the Power of Attorney should correlate with the name in Form 40.
  • It should be valid for the period of said Registration Certificate.

6. A duly attested /notarized (in India) and valid copy of Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B or its renewal in Form 21C issued by the State Drug Licensing Authority.

Or

Duly attested /notarized (in India) and valid copy of Manufacturing License issued by the State Drug Licensing Authority in case the Indian Manufacturer is importing the kits in bulk form for further processing.

7. Duly notarized/Apostilled/Attested (by Indian Embassy in the country of origin) and valid copy of Free Sale Certificate/Certificate to Foreign Government/ Certificate of Marketability for each kit issued by National Regulatory Authority of country of origin and any one of the countries Viz. USA, Canada, Japan, Australia and European Union clearly stating that the proposed Kits/Reagents are freely sold in the respective countries and can be legally exported. It should also specify the name and address of legal and actual manufacturing site along with applied product name(s) in generic and Brand name, if any.

8. Duly notarized/Apostilled/Attested (by Indian Embassy in the country of origin) and valid copy of ISO 13485 Certificate in respect of the manufacturing site (s).

9. Duly notarized/Apostilled/Attested (by Indian Embassy in the country of origin) and valid copy of CE Full Quality Assurance Certificate in respect of the legal and actual manufacturing site (s), if applicable.

10. Duly notarized/Apostilled/Attested (by Indian Embassy in the country of origin) and valid copy of CE Design Certificate in respect of the proposed Kit(s), if applicable.

11. Duly notarized/Apostilled/Attested (by Indian Embassy in the country of origin) and valid copy of Declaration of Conformity in respect of the proposed Kit(s).

12. Performance Evaluation Report from National Institute of Biologicals, Noida, India in respect of Proposed Kit(s) of three Consecutive batches.

13. The report of evaluation in detail, conducted by the National Control Authority (NCA) of Country of origin in respect of Proposed Kit(s) of three Consecutive batches. If the Evaluation report from NCA is not available then Evaluation / Batch release report from the authorized Notified body may also be accepted.

14. Product Inserts (English version or Authenticated translated copy) mentioning Specificity and Sensitivity wherever applicable and published articles (if any) for each Diagnostic kits/ Reagents proposed to be imported.

15. Original Colored Labels and pack size in respect of the proposed products.

16. A) A duly filled Schedule D (I) along with the undertaking as per the Performa prescribed in the Drugs & Cosmetics Act & Rules, signed & stamped by the manufacturer indicating the name and designation of the authorized signatory is required to be submitted Performa for Schedule D (I) is given in Annexure IV.

B) The requirements for Plant / Site Master File are enclosed at Annexure- V.

17. A) A duly filled Schedule D (II) along with Annexure -B as per the Performa prescribed in the Drugs & Cosmetics Act & Rules, signed & stamped by the manufacturer indicating the name and designation of the authorized signatory is required to be submitted as per Annexure VI.

B) The requirements for device Master File are enclosed at Annexure II.

18. Specimen batch test report for at least three consecutive batches showing specification of each testing parameters from Manufacturer.

19. The detailed test report of all the components used/packed in the finished kit.

20. Manufacturer’s undertaking for the product self-life , Specificity and Sensitivity of the proposed product wherever applicable

21. Soft copy of Dossier summary sheet in Word format

Note:

  • Soft copy of the Plant Master File and Device Master File must also be submitted along with the application.
  • All certificates submitted should be within the validity period and should have at least six months valid period at the time of submission of application.
  • All above mentioned regulatory and legal documents may be provided in a single file in the same sequence (From S.No. 1-19) Plant Master File and Device Master File may be provided as separate files.
  • In case of re-registration / Endorsement, a copy of registration certificate in Form-41 should be submitted along with application.

Annexures

B.1. Checklist for Pre Screening of Applications for Grant of Registration Certificate/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. NoAdministrative/Legal /Technical DocumentsStatus

Please Tick(√ )
Pg. No.Annexure
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 containing 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.)
3.Application in Form-40
3.1.Duly signed & stamped by the Applicant
3.2.Name of the Medical Device(s) to be registered along with Brand Name, Generic Name, Intended Use, Shelf Life etc.
3.3.Name & Full Address of Authorized Agent in India
3.4.Names & Full Address of Manufacturer & its Factory Premises
4.TR6 Challan
4.1.Fees paid
Total USD………….Equivalent to………………INR( _________ for site &_________for product)
4.2.Head to Fees Deposited (“0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines)
4.3.Should indicate the name and address of the premises to be registered
4.4Realization Stamp
5Power of Attorney(Original)
5.1Authenticated 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
5.2Name & Full Address of the manufacturer & the manufacturing site (in line of clause 3.4)
5.3Name and full address of the Indian Agent
5.4Name of the Proposed Products(in line of clause 3.2)
5.5Duly signed, dated with name & designation of the signatory by both Indian agent & the manufacturer
6.Duly notarized Copy of valid Wholesale Licence or Manufacturing Licence of the Indian Agent
7.Duly filled Schedule DI &Undertaking duly signed, stamped & dated with name & designation of the manufacturer.
8.Duly filled Schedule DII along with Undertaking signed, stamped & dated with name & designation of the manufacturer.
8.1Information as per Annexure B(HIV, HCV, HBV & Blood Grouping Sera) of Schedule DII
9.Regulatory Certificates :
9.1Duly Apostilled/notarized and authenticated by Indian Embassy in the country of origin) & Valid Copies of Quality Certification 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
9.2Duly 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 :
10.1Duly 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
11.Notarized Plant Master file from country of origin including the following information:
a) Layout of premises, manufacturing activities, total employees and organisation chart
b) Plant registration certificate/ approval certificate issued by NRA
c) Brief information on the site's relation to other sites etc.
d) Brief description of major production and quality control laboratory equipment
e) Location & layout plan of premises
f) Flow chart. Brief details of manufacturing process, quality control system
g) System of conformity document that the manufacturer follows
12.Notarized Device Master file from country of origin including the following information:
a) Device Description, Product Specification & flow chart of the manufacturing process of the device
b) Comparative chart of the proposed product along with similar product approved in India
c) Quality Control Reports in respect of raw materials & finished products, sterilization reports etc.
d) Clinical trial data/Published data.
e) Biocompatibility Reports, Physiochemical testing reports
f) Test specifications & method of testing
g) Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 batches
h) Risk Management Report and Essential Principle Checklist
i) Original label and Draft label,
j) Stability data both for Accelerated & Real time.
k) 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
17.1Detail 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)
17.2Detail 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

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:…………….…………….
Date:…………….…………….

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 DocumentsStatus

Please Tick(√ )
Pg. No.Annexure
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 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.)
3.Application in Form-40
3.1Duly signed & stamped by the Applicant
3.2Name of the Medical Device(s) to be registered along with Brand Name, Generic Name, Intended Use, Shelf Life etc.
3.3Name & Full Address of Authorized Agent in India
3.4Names & Full Address of Manufacturer & its Factory Premises
4.TR6 Challan
4.1Fees paid Total USD………….Equivalent to………………INR( _________ for site &_________for product)
4.2Head to Fees Deposited (“0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines)
4.3Should indicate the name and address of the premises to be registered
4.4Realization Stamp
5.Power of Attorney(Original)
5.1Authenticated 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
5.2Name & Full Address of the manufacturer & its manufacturing site (in line of clause 3.4)
5.3Name and full address of the Indian Agent
5.4Name of the Proposed Products(in line of clause 3.2)
5.5Duly signed, dated with name & designation of the signatory by both Indian agent & the manufacturer
6.Duly notarized Copy of valid Wholesale Licence or 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.
8.1Information as per Annexure B(HIV, HCV, HBV & Blood Grouping Sera) of Schedule DII
9.Regulatory Certificates :
9.1Duly 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).

(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
9.2Duly 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 :
10.1Duly 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
11.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.
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
15.Duly notarized PMS Study Report
16.1Detail 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)
16.2Detail 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:…………….…………….

Web Link for Download:

Guidance Document on Common Submission Format for Import of Notified Diagnostic Kits in India (IVD’s)
http://www.cdsco.nic.in/writereaddata/Form%20-10%20Doc%20-%20cd.pdf

Pre- Screening Checklist for – Medical Devices and Diagnostics Division Checklist

Feel free to contact us for any query or clarification

Regards
Dr. Manoj Karwa
Head- Clinical Operations
Auriga Research Ltd

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