Requirement for conducting clinical trials of medical devices in India

Module 9

A new medical device is one which does not have a predicate medical device registered / approved in India. A predicate medical device is one which is registered / approved in India and has the same indications/ intended use, material of construction and design characteristics as the device which is proposed for registration in India. Process for registration of a new medical device different from that of a medical device for which predicates exist. Notified medical devices for which predicate devices are not registered in India are classified as new medical devices. These medical devices are referred to the Medical Device Advisory Committees (MDAC) or Subject Expert Committee (SEC) to comment on safety, effectiveness, essentiality and desirability of proposed New Devices. Further, the CDSCO has also formulated a General Expert Pool for Medical Device Advisory Committee to advise the Drugs Controller General of India in matters related to review and regulatory approval of new medical devices and clinical trials.

CLINICAL TRIALS OF MEDICAL DEVICES IN INDIA

Note: All information/reports/data should be in English only. It is expected that the information submitted in the form of hard copy shall also be submitted in the form of soft copy.

The application for conducting clinical trials for Medical Devices in India should include following documents/information but not limited to:

1. Covering Letter : Indicating the precise intent of the application (e.g. whether the application is for Feasibility study or Safety and Efficacy study/Post Market study and purpose for conducting the study), name and address of the manufacturer as well as applicant, name of the device ICH clinical trial is to be carried out along with a list of documents attached (Index) along with any other relevant information regarding the subject application. It should be signed by Authorized Signatory, clearly reflecting the name and designation of the Authorized Signatory.

2. Duly filled Application in Form 44 as prescribed in Drugs & Cosmetics Act and Rules there under, signed and stamped by the authorized signatory, clearly indicating the name and designation of the Authorized Signatory. Performa for Form 44 is available at Annexure – I. Technical data pertaining to the subject Medical Device should be submitted as per Annexure II.

3. Requisite Fee as per the provisions of Drugs & Cosmetics Act and Rules there under in the Form of TR6 Challan issued by Bank Baroda. Fee can 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 annexed at Annexure – III. TR6 Challan receipt (in original) needs to be submitted clearly specifying the fee deposited. The fee to be paid is as follows:

  1. For Feasibility Study (i.e. Safety and efficacy study); which is equivalent to Phase I trials in case of drugs: Rs 50, 000/-
  2. For Pivotal Study (i.e. Confirmatory trials); which is equivalent to Phase II/III trials in case of drugs: Rs 25, 000/-

4. Delegation of Responsibility: Declaration from the sponsor required to be submitted in original on Sponsor’s letterhead stating the extent of delegation of responsibilities to the Principle Investigator.

5. Protocol: Information to be submitted in Protocol is available at Annexure IV.

6. Global Regulatory status of the device: (particularly in 5 GHTF countries i.e. USA, Australia, Japan, Canada and European Union)

  1. Clinical trial in each participating country: Copies of regulatory approval letters, IRB/EC approvals, number of study centers per country, number of subjects recruited (Protocol specific) from participating countries (if available)

Regulatory status of device in other countries (if applicable)

  1. Approved
  2. Marketed (if marketed a copy of package insert)
  3. Withdrawn, if any, with reasons
  4. Free sale certificate or certificate of analysis, as appropriate
  5. ISO Certificates and/or CE certificate (if available)

7. Investigator’s Undertakings : as displayed in Annexure VII

8. Ethics committee approval letters (if available): Information for constitution of Ethics Committee and Format for approval of Ethics Committee is available at Annexure VIII 

9. Informed consent form: Checklist for study Subject’s informed consent documents and Format of informed consent form for Subjects participating in a clinical trial are enclosed at Annexure IX

10. Case Record Form: Format for Case Record Form should be submitted.

11. Patient Record Form: Format for Patient Record Form should be submitted.

12. Relevant published literature for the subject device/predicate device (s) should be submitted.

13. Investigator’s Brochure: Investigators brochure should be submitted.

14. Suspected Unexpected Serious Adverse Reaction (SUSAR) from other participating countries if any reported and summary of any reported problems should be submitted.

15. Affidavit from the sponsor that the study has not been discontinued in any country and in case of discontinuation the reasons for such a discontinuation and that the applicant would further communicate to DCG (I) about the future discontinuation and Investigator’s Brochure containing the summarized information is based on the facts.

16. Any other specific relevant information w.r.t. Subject device.

17. Clinical Study Report: Structure, contents and format for Clinical Study Report is enclosed at Annexure X.

Annexures

  1. Annexure I – Format for Form 44
  2. Annexure II – Technical Data to Be Submitted Along With the Application for the Subject Medical Device
  3. Annexure III – Format for TR6 Challan
  4. Annexure IV – Contents of the Proposed Protocol for Conducting Clinical Trials
  5. Annexure V – Phase study assessment
  6. Annexure VI – Data elements for reporting serious adverse events occurring in a clinical trial
  7. Annexure VII – Undertaking by the investigator
  8. Annexure VIII – Ethics Committee and Format for Approval of Ethics Committee
  9. Annexure IX – Checklist for study subject’s informed consent documents and format of Informed Consent Form
  10. Annexure X – Structure, contents and format for clinical study report

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.Status
Please Tick(√ )
Pg. No.
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
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. It should include following information:
a. Name of the Applicant
b. Name of the Medical Device
c. Composition/Accessories
d. Intended Use etc.
4.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
5.Protocol:
the contents of Protocol should be as follows:
iTitle page
iiTable of content
iiiStudy Objective(s) (primary as well as secondary) and their logical relation to the study design
ivStudy design
vStudy population
viSubject Eligibility- Inclusion Criteria and Exclusion Criteria
viiStudy Assessment
viiiStudy Treatment
ixAdverse Events
xEthical Consideration
xiStudy Monitoring and Supervision
xiiInvestigational Product Management
xiiiData 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)
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:…………….…………….
Date:…………….…………….

Web Link for Download:

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

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

Disclaimer: Auriga Research Ltd has tried to arrange content in a simplified manner and accepts no liability for the content. For more updated information, Please visit CDSCO website or link provided above.