Seventh schedule

Submitted By :- Gurneet Kaur

 Objective
Requirements for permission to
import or manufacture
investigational medical device for
conducting clinical investigation
Contents:-
1) Application for permission

2) Clinical Investigation
I. Approval for Clinical Investigation
II. Responsibilities of Sponsor
III. Responsibilities of Investigator
IV. Responsibilities of Ethics Committee
V. Informed Consent
VI. Pilot Clinical Investigation
VII. Pivotal Clinical Investigation
VIII.Post Marketing Clinical Investigation
IX. Studies in special population

3) Post Marketing Surveillance

4) Tables
 1) Application for permission
• Application in Form MD-22 to CLA containing following data
1. Design analysis data (Table 1)
2. Biocompatibility and Animal Performance Study (Table 2)
3. IB (Table-4), CIP (Table-5), CRF (Table-6), serious adverse event report
(Table-7), ICF (Table-8), IU (Table-9) & EC Approval
4. Regulatory status in other countries
5. Proposed Instruction for use
6. Report of Clinical Investigation (Table-10)

• For IMD developed in India, CI required to be carried out in India and

data generated submitted
• For IMD developed outside India, relevant clinical study data should be
submitted along with application
 2) Clinical Investigation
I. Approval for CI

 Study to be initiated only after approval

 Investigator should be adequately qualified
 Laboratories used for generating data should be
complaint with Good Laboratory Practices
 All amendments of CIP should be submitted to
CLA & EC within 30 days
II. Responsibilities of sponsor
• Implementing and maintaining QA
• Submit status report on CI to CLA
• Report serious adverse event (SAE) to EC & CLA within
14 days from knowledge
• Provide financial compensation in case of injury or death
• Submit details of compensation paid to CLA
• Provide CIR to EC, CLA & participating investigators
• Inform CLA & submit summary report in case of
premature discontinuation of CI
III. Responsibilities of investigator

• Conduct of investigation acc. to CIP & GCP

guidelines
• Documentation of standard operating procedure
• Ensure adequate medical care for any AE
• Report SAE to CLA, EC & sponsor within 48 hrs
of their occurance
• Provide all information related to the trial to CI
subject through informed consent process
IV. Responsibilities of EC
• Protect rights, safety & well being of all study
subjects
• Get documented ‘standard operating procedures’
and maintain record of proceedings
• Undertake ongoing review of investigation of
CIP
• Record reasons to revoke sites approval accorded
to CIP and communicate such decision to
Investigator & CLA
V. Informed consent
• Freely given, informed, written consent required
in all investigations
• ‘Informed Consent Form’ used to obtain consent of
subject
• Consentto be obtained from legally acceptable
representative, if subject not able to give informed
consent
• If
legally acceptable representative unable to read
or write, impartial witness should be present
• Incase of pediatric patients, informed consent
is obtained from their parents or legal guardian
• However the pediatric patient shall be
informed to fullest extent
• Paediatric patients should assent to enroll in
study
• Matureminors and adolescents should sign
and date a seperately designed consent form
• Essential elements of written consent given in
Table-8
VI. Pilot clinical investigation
• Exploratory study used to acquire specific
essential information
• Conducted in few number of patients
• Objective-accessing feasibility, exploring
eligibility criteria & their practical application,
studying device mechanism, evaluating logistics
for performance
VII.Pivotal Clinical Investigation

• Confirmatory study
• Evidence gathered to support safety &
effectiveness evaluation of medical device
• Conducted in large number of patients
• If
IMD approved in other countries, pivotal study
needs to be carried out in Indian patients
VIII.Post marketing clinical investigation

• Study performed after marketing approval is

given
• Not necessary at time of approval
• May be required by CLA for optimizing intended
use
• Includesadditional drug device interaction,
safety studies, investigation designed to support
use under the approved indication, etc
IX. Study in special population
• Special population includes
1. Geriatrics
2. Paediatrics
3. Pregnant & nursing women
• CI study performed in special population ONLY
during following conditions:-
 The disease to be treated is characteristically a
disease in these patients
 The response is likely to be altered in them as
compared to normal adult
 IMD is intended to treat serious or life threatening
diseases
 3) Post marketing surveillance
• To monitor clinical safety of IMD once marketed
• Periodic safety update reports (PSURs)- pharmacovigilance
documents intended to provide worldwide safety report
• Applicants furnish PSURs to:-
a) Report all relevant new information
b) Relate data to patient exposure
c) Summarise the market authorisation status in diff countries &
significant variation related to safety
d) Indicate whether changes will be made to product information in
order to optimize use of product
• One MD should be covered in one PSUR
• First two years after marketing, PSURs submitted every 6
months
• For subsequent 2 years, PSUR submitted annually
• CLA may extend duration of submission of PSURs
• PSURs should contain new studies planned or conducted
for safety issues
• STRUCTURE OF PSUR :-
a) Title page- contain name of MD, reporting interval,
approved indication, date of approval, date of marketing,
licence name, address
b) Introduction- contain reporting interval, approved
indication of MD, mode of action, risk class & brief
description of approved indication & population
c) Current worldwide marketing authorisation status-
brief narrative overview including countries where device is
approved, date of approval, date of marketing & if
withdrawn from any country
d) Action taken in reporting interval for safety
reasons- description of significant actions related to
safety that have been taken during reporting interval
e) Changes to reference safety information-
information relating to contradictions, warnings,
precautions, AE, etc.
f) Estimated patient exposure- estimated size &
nature of population exposed to MD
g) Presentation of individual case histories-include
individual case information available to licence holder
& provide brief case narrative, medical history
indication treated with suspected MD, causality
assessment
h) Studies- contain brief summary of clinically
important emerging efficacy or effectiveness and
safety findings obtained by licence holder
i) Other information- include details about:-
 Signal and risk evaluation
 Risk management report
j) Overall safety evaluation- contain:-
 Summary of safety concerns
 Benefit evaluation
 Benefit risk analysis evaluation
k) Conclusion- provide all details on safety profile of
MD and necessary action.
l) Appendix- includes copy of marketing authorisation
in India, copy of prescribing information, line listing
with narrative of ICSR.
 4) Tables
Table 1 Design analysis data
Table 2 Biocompatibility and animal performance study for
investigational medical device
Table 3 Information to be submitted along with the application
Table 4 Investigator’s brochure
Table 5 Clinical investigation Plan
Table 6 Case Report Form
Table 7 Data elements for reporting serious adverse event occurring
in clinical investigation
Table 8 Informed Consent Form
Table 9 Undertaking by Investigator
Table 10 Clinical Investigation Report
THANK
YOU