Web-link and Other Checklists for Medical Devices and Diagnostic Kits

Module 10

  1. Guidance Document on Application for Grant of License in Form-28 for Manufacture of Medical Devices in India Under CLAA Scheme(01.01.2013) http://www.cdsco.nic.in/writereaddata/Final%20Guidance_Doc_Form-28_31-10-2012.pdf
  2. Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Medical Devices in India (01.01.2013) http://www.cdsco.nic.in/writereaddata/Final%20Guidance_Doc_RC_31-10-2012.pdf
  3. Guidance Document on Common Submission Format for Import License in Form-10 of Notified Medical Devices in India (01.01.2013) http://www.cdsco.nic.in/writereaddata/Final%20Guidance_Doc_Import_Licence_31.10.2012.pdf
  4. 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
  5. Guidance Document on Common Submission Format for Import of Non-Notified Diagnostic Kits in India (IVD’s) http://www.cdsco.nic.in/writereaddata/Form-10%20%20Doc%20-%20ncd.pdf
  6. Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Diagnostic Kits in India (IVD’s) http://www.cdsco.nic.in/writereaddata/IVD%20RC%20final%20.pdf
  7. REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS OF MEDICAL DEVICES IN INDIA http://www.cdsco.nic.in/writereaddata/Requirements%20for%20Conducting%20Clinical%20Trial(s)%20of%20Medical%20Devices%20in%20India.PDF
  8. Draft Schedule MIII -Requirements for factory premises for Medical Devices and In-vitro Diagnostic products http://www.cdsco.nic.in/writereaddata/SCHEDULE_M_III(Requirements%20of%20GMP%20for%20MD%20&%20IVD).pdf
  9. List of Notified Medical Devices http://www.cdsco.nic.in/writereaddata/list%20of%20notified%20medical%20device.pdf
  10. Non- Compliance observed During Review Process of application for Registration & Import Licenses of Medical Devices http://www.cdsco.nic.in/writereaddata/Noncompliances%20Applications%20Registration%20&%20Import.pdf
  11. Organogram of Medical Device Division http://www.cdsco.nic.in/writereaddata/Medical%20Device%20organo.pdf
  12. Pre-screening Or Checklist

13. Guidance document on common submission format for Manufacture of Medical Devices (Form-28) Under CLAA Scheme http://cdsco.nic.in/writereaddata/Guidance_doc_MD_form28.pdf

14. Circular on common Submission Format for Registration(Form-41)(Excluding Notified IVD’s), Import Licence(Form 10)(Excluding IVD’s) and Manufacture of Medical Devices (Form- 28) Under CLAA Scheme
http://cdsco.nic.in/writereaddata/Guidance_doc_form_41.pdf

15.Guidelines for Import and Manufacture of Medical Devices (01.03.2006)
http://cdsco.nic.in/writereaddata/GUIDELINES%20FOR%20IMPORT%20AND%20MANUFACTURE%20OF%20MEDICAL%20DEVICES.pdf

16. USE OF RAPID TEST KITS FOR TESTING OF HIV AND HCV IN BLOOD BANKS (IVD’s)
http://cdsco.nic.in/writereaddata/Use%20of%20Rapid%20Test%20Kits%20for%20Testing%20of%20HIV%20and%20HCV%20in%20Blood%20Banks..pdf

GENERAL FORMATS

  1. Non-conviction Certificate
  2. Performance Certificate
  3. Market Standing Certificate
  4. TR6 Challan
  5. Power of Attorney
  6. Form 40
  7. Form 44
  8. Form 8
  9. Form 9
  10. Form 12
  11. Form 12A
  12. Form 12AA
  13. Form 27

18. Frequently asked Question on registration and import of medical devices in India (Under Revision)
http://cdsco.nic.in/writereaddata/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf

19. Frequently Asked question in Vitro Diagnostic IVD Devices
http://cdsco.nic.in/writereaddata/Final%20FAQS-IVD.pdf

20. Draft Schedule MIII -Requirements for factory premises for Medical Devices and In-vitro Diagnostic products
http://cdsco.nic.in/writereaddata/SCHEDULE_M_III-(Requirements%20of%20GMP%20for%20MD%20&%20IVD).pdf

Checklists enclosed here are:

  1. A.3 Checklist for Pre Screening of Applications for Grant of Test License in Form-11 for small quantity of medical devices
  2. A.6 Pre- screening checklist for Extension in shelf life of the already Registered Product
  3. A.7 Checklist for Pre Screening of Applications for Additional Indication of the already Registered Product
  4. A.8 Checklist for Pre Screening of Applications for Further Clarification in respect of the Product
  5. B.3. Checklist for Pre Screening of Applications for Grant of Test License in Form-11 for in-vitro diagnostic Kits/reagents

Test license in Form 11 is to import small quantities of drugs / Medical Devices/ Diagnostic kits, for the purpose of examination, test or analysis provided that Imported Medical Devices under Form 11 shall not be used for any commercial purposes. A Test License unless, it is sooner suspended or cancelled, shall be valid for a period of one year from the date of its issue

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 DocumentsStatus
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 products
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:….……………………….

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: ___________________________      Date: _______________

S. No.Administrative/Legal Documents.Status
Please Tick(√ )
Pg. No.Annexure
1.Covering Letter-Purpose should be clearly mentioned with page number and Index.
2.Copy of Registration certificate mentioning the name of the product along with approved shelf life of the devices
3.Certificate of Approval of extension in shelf life issued by National Regulatory Authority in country of origin
4.Stability Data including Stability protocol and real time as well as accelerated stability test reports as per extension in shelf life proposed
5.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:…………….…………….

A.7 Checklist for Pre Screening of Applications for Additional Indication of the already Registered Product

Name of the firm: ____________________                     Date: _______________

S. No. Administrative/Legal Documents.Status
Please Tick(√ )
Pg. No.Annexure
1.Covering Letter-Purpose should be clearly mentioned with page number and Index.
2.Copy of Registration certificate mentioning the name of the product along with indication approved earlier
3.Certificate of Approval of additional indication issued by National Regulatory Authority in country of origin
4.Published data/detail of the study carried out for the additional indication
5.List of the countries where product with additional indication approved along with regulatory documents
6.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:…………….…………….

A.8 Checklist for Pre Screening of Applications for Further Clarification in respect of the Product

Name of the firm:____________________________ Date: __________

S.No. Administrative/Legal Documents.Status
Please Tick(√ )
Pg. No.Annexure
1.Covering Letter-Purpose should be clearly mentioned with page number and Index.
2.Detail Product description along with material of construction, intended use, Product specification, product literature, package inserts
3.Regulatory status of the said product in country of origin
4.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:…………….…………….

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. NoAdministrative/Legal /Technical Documents.Status

Please Tick(√ )
Pg. No.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: