PROJECT OF GUIDANCE ON REQUIREMENTS FOR CLINICAL

Page 1 of 22

1

2 Draft for comment purposes (Not for implementation) 3

4

5

6

7

8

9

10

PROJECT OF GUIDANCE ON REQUIREMENTS FOR 11

CLINICAL INVESTIGATIONS OF MEDICAL DEVICES 12

13

14 15

16

17

18 This document is being distributed for comment purposes only. Comments and 19 suggestions regarding this draft document should be submitted within 30 days of 20 publication on the SFDA’s website. Kindly, submit comments to the 21 [email protected] by using the Commenting Template at 22 <http://www.sfda.gov.sa/en/medicaldevices/resources/Documents/Commenting-23 Template.docx > 24

25 26

27

28

29

30

31

http://www.sfda.gov.sa/en/medicaldevices/resources/Documents/Commenting-Template.docx



Page 2 of 22

TABLE OF CONTENT 32

33 DEFINITIONS & ABBREVIATIONS ..................................................................................... 3 34

Definitions .............................................................................................................................. 3 35

Abbreviations .......................................................................................................................... 6 36

37

INTRODUCTION ..................................................................................................................... 7 38

Purpose ................................................................................................................................... 7 39

Scope……… ........................................................................................................................... 7 40

Background ............................................................................................................................. 7 41

42

REQUIREMENTS .................................................................................................................... 8 43

REQUIRED DOCUMENTS ................................................................................................... 10 44

FLOWCHART ........................................................................................................................ 13 45

46

ANNEXES ............................................................................................................................... 14 47

Application Form for CIMD .................................................................................................. 15 48

Change Form for CIMD ........................................................................................................ 22 49

50 51

Page 3 of 22

DEFINITIONS & ABBREVIATIONS 52

53

Definitions 54

Medical Device means any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other

similar or related article:

A. Intended by the manufacturer to be used, alone or in

combination, for human beings for one or more of the

specific purpose(s) of:

o Diagnosis, prevention, monitoring, treatment or alleviation of disease,

o Diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap, o Investigation, replacement, modification, or support of

the anatomy or of a physiological process,

o Supporting or sustaining life,

o Control of conception, o Disinfection of medical devices,

o Providing information for medical or diagnostic purposes

by means of in vitro examination of specimens derived from the human body;

and

B. Which does not achieve its primary intended action in or on the human body by pharmacological, immunological or

metabolic means, but which may be assisted in its intended

function by such means.

Investigational Medical Device

is a medical device being assessed for safety or performance in a clinical investigation. The definition cover other product including

prescription eyeglasses, contact lenses and their solutions. This

includes medical devices already on the market, that are being evaluated for new intended uses, new populations, new materials or

design changes.

Medical Devices

National Registry (MDNR)

is the database of registered establishments and the medical devices

they manufacture or import or distribute.

establishment

National Registry

Number

means the number issued to a person by the SFDA under the

establishment registration provisions of the Medical Devices Interim

Regulation.

Medical Device

National Listing

Number

means the code assigned by the SFDA to a single medical device,

that has been included in a marketing authorization application, to

indicate the device is authorized to be placed on the KSA market and facilitate traceability.

National Centre for

Medical Device

Reporting (NCMDR)

means an organization managing a database of information on safety

and/or performance related aspects of medical devices and

employing staff capable of taking appropriate action on any confirmed problems.

Adverse Event means any malfunction or deterioration in the characteristics and/or

performances of a medical device, including any inadequacy in its

Page 4 of 22

labeling or the instructions for use which may lead to compromise

the health or safety of patients, users or third parties.

Reportable Adverse

Event

means any adverse event or any technical or medical reason leading

to a Field Safety Corrective Action, which, directly or indirectly, might lead to or may have led (a) to the death of a patient, a user or

another person or (b) to a serious deterioration in their state of

health.

Global Harmonization

Task Force (GHTF)

Countries working to achieve harmonization in medical device

regulation among themselves. These countries are Australia, Canada, Japan, the USA and the EU/EFTA.

Authorized

Representative (AR)

means any natural or legal person established within the KSA who

has received a written mandate from the manufacturer to act on his behalf for specified tasks, including the obligation to represent the

manufacturer in its dealings with the SFDA.

Sponsor means an individual or organization taking responsibility and

liability for the initiation or implementation of a clinical investigation.

Investigator is an individual member of the investigation site team designated and

supervised by the principal investigator at an investigation site to

perform critical clinical-investigation-related procedures or to make important clinical investigation - related decisions.

An individual member of the investigation site team can also be called “sub-investigator” or “co-investigator”.

Clinical Data means safety and/or performance information that are generated

from the clinical use of an investigational device.

Clinical Investigation is a systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device.

Clinical Investigation

Plan (CIP)

document that state(s) the rationale, objectives, design and proposed

analysis, methodology, monitoring, conduct and record-keeping of

the clinical investigation. The term “protocol” sometimes used as a synonymous with “Plan”.

Clinical Investigation

Report

is a written form document describing the identification of the

device(s), the methodology, the design, any deviations from the CIP, execution, data analysis together with statistical analysis, a critical

appraisal of the aims of the clinical investigation, and results of a

clinical investigation.

Ethics Committee (EC)/ Institutional

Review Board (IRB)

an independent body whose responsibility is to review clinical investigations in order to protect the rights, safety and well-being of

human subjects participating in a clinical investigation.

Comparator is medical device, therapy (e.g. active control), placebo or no

treatment, used in the reference group in a clinical investigation.

Completion Date means the date that the final subject was examined or received an

intervention for the purposes of final collection of data for the

primary outcome, whether the clinical investigation concluded according to the prespecified protocol or was terminated.

Contract Research

Organization (CRO)

means a person or organization contracted by the sponsor to perform

one or more of the sponsor's clinical investigation-related duties and

functions.

Page 5 of 22

Deviation instance(s) of failure to follow, intentionally or unintentionally, the

requirements of the CIP.

Endpoint(s) means indicator(s) measured or determined to assess the objectives of a clinical investigation, prospectively specified in the clinical

investigation plan.

I. ⟨primary⟩ principal indicator(s) used for assessing the primary hypothesis of a clinical investigation.

II. ⟨secondary⟩ indicator(s) used for assessing the secondary

hypotheses of a clinical investigation.

Informed Consent A person giving his consent with his free will, without exploitation or coercion and upon full understanding of what is required from

him and of the research objectives and potential risks as well as of

rights and obligations arising out of his participation therein.

Intended Use/Purpose means the objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications,

instructions for use and information provided by the manufacturer.

Investigation Site is a site where the clinical investigation is carried out. For the purpose of this guidance, “investigation site” is synonymous

with “investigation center”.

Investigator's

Brochure (IB)

is a compilation of the current clinical and non-clinical information

on the investigational medical device(s), relevant to the clinical investigation.

Labelling means written, printed or graphic matter

A. Affixed to a medical device or any of its containers or

wrappers.

B. Information accompanying a medical device, related to

identification, technical description.

C. Information accompanying a medical device, related to its

use, but excluding shipping documents.

Instructions for Use

(IFU)

means information provided by the manufacturer to inform the

device user of the medical devices intended purpose and proper use

and of any precautions to be taken.

Malfunction means a failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with

the instructions for use or CIP.

Monitoring is the act of overseeing the progress of a clinical investigation and to

ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, this International Standard, and the

applicable regulatory requirements.

Multicenter Investigation

refer to a clinical investigation that is conducted according to a single CIP and takes place at two or more investigation sites.

Objective means the main purpose for conducting the clinical investigation.

Principal Investigator is a qualified person responsible for conducting the clinical

investigation at an investigation site. If a clinical investigation is conducted by a team of individuals at an investigation site, the

principal investigator is responsible for leading the team.

Start Date is the date of the clinical investigation initiation when the enrollment

to the protocol begins.

Subject is an individual who participates in a clinical investigation. A subject

Page 6 of 22

can be either a healthy volunteer or a patient.

Use Error means an act, or omission of an act relating to the use of a product

within the scope of this Regulation, whereby the resulting outcome is different from that intended by the manufacturer or expected by the

user.

Vulnerable Subject refer to an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether

justified or not, of benefits associated with participation or of

retaliatory response from senior members of a hierarchy in case of

refusal to participate. Example Individuals with lack of or loss of autonomy due to

immaturity or through mental disability, persons in nursing homes,

children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and

those incapable of giving informed consent. Other vulnerable

subjects include, for example, members of a group with a

hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor,

members of the armed forces, and persons kept in detention.

55

Abbreviations 56

KSA Kingdom of Saudi Arabia

SFDA Saudi Food and Drug Authority

MDS Medical Devices Sector

GHTF Global Harmonization Task Force

MDNR Medical Device National Registry

MDMA Medical Devices Marketing Authorization

AR Authorized Representative

CIMD Clinical Investigations of Medical Devices

IFU Instructions for Use

CRO Contract Research Organization

CIP Clinical Investigation Plan

EC Ethics Committee

IRB Institutional Review Board

NCMDR National Centre for Medical Device Reporting

IB Investigator's Brochure

NCBE National Committee of Bio Ethics

57

Page 7 of 22

INTRODUCTION 58

59

Purpose 60

The purpose of this document is to clarify requirements of conducting CIMD within KSA. 61

62

63

Scope……… 64

This document is applicable to any party wishes to conduct CIMD or its accessories within KSA. 65

66

Background 67

Medical devices may be placed on the market and/or put into service only if they comply with the 68

applicable provisions of the Medical Devices Interim Regulation, as signified by the SFDA 69

issuing the manufacturer with a written marketing authorization (MDMA). 70

71

Devices that may access KSA for purposes rather than marketing, such as for clinical 72

investigations, are exempt from marketing authorization requirements. However, SFDA requires 73

approval for conducting CIMD or its accessories within KSA, in order to protect the rights, safety 74

and well-being of participants during the clinical investigation, and to ensure the scientific 75

conduct of the clinical investigation and the credibility of the clinical investigation results. For 76

achieving that, SFDA issued this document. 77

78

79 80

81

Page 8 of 22

REQUIREMENTS 82

General 1 Any CIMD or its accessories within KSA shall be approved by SFDA

before commence.

Regulations and

Standards

2 CIMD shall be complied with the Law of Ethics of Research on

Living Creatures.

3 CIMD should be complied with:

o Declaration of Helsinki and

o GCP/ISO 14155.

Labeling

Requirements

4 The labeling of device shall be complied with the requirements that

described in SFDA’s guidance document entitled MDS – G10

Guidance on Labelling Requirements for Medical Devices.

Adverse Events

Reporting

5 Sponsor shall report to the SFDA’s NCMDR, IRBs, and investigators

any reportable adverse event of which it becomes aware, that involves

the medical device. This shall be reported without delay but not later

than 10 working days of occurrence.

For more details see the SFDA’s guidance document entitled MDS –

G6 Guidance on Post-Marketing Surveillance.

Pre-requisite

6 Before applying for CIMD:

- the sponsor located within the KSA are required to have an

Establishment National Registry Number that is issued

through SFDA’s MDNR. Independent individuals are

exempt.

- the sponsor located outside the KSA are required to assign an

AR, the AR is required to have:

- an establishment National Registry Number that is

issued through SFDA’s MDNR, and

- an AR license. Information on this procedure see

SFDA’s guidance document entitled MDS – G3

Guidance on for Authorized Representatives.

Submitting

Documents to

SFDA and the

approval

7 Sponsor (either is located within KSA, or outside the KSA, by its

AR) shall submit the required documents by email to

[email protected] ,:

1. prior to CIMD, the required documents are specified in

section (Required Documents-A). SFDA responds to the

applicant within a week with the missing required documents

and once satisfied, SFDA will send a “no objection letter”

together with an importation license, if needed, to the

mailto:[email protected]

Page 9 of 22

applicant’s email within 60 calendar days.

2. during the CIMD, the required documents are specified in

section (Required Documents-B).

3. at the end of the CIMD, the required documents are specified

in section (Required Documents-C).

Reviewing Fees 8 No fees are required for reviewing CIMD applications.

83

84

85

86

87

88

Page 10 of 22

89

REQUIRED DOCUMENTS 90

Required Documents Sample Note

A. Required document prior to CIMD

1 Application Form for CIMD See

Annex1 Before applying for CIMD:

- the sponsor located within the

KSA are required to have an

Establishment National Registry

Number that is issued through

SFDA’s MDNR. Independent

individuals are exempt.

- the sponsor located outside the

KSA are required to assign an

AR, the AR is required to have:

o an establishment

National Registry

Number that is issued

through SFDA’s MDNR

o an AR license.

Prior to CIMD, applicant shall

provide the required documents that

specified in section (Required

Documents-A) by email to

[email protected].

SFDA responds to the applicant

within a week with the missing

required documents and once

satisfied; SFDA will send a “no

objection letter” together with an

importation license, if needed, to the applicant’s email within 60 calendar

days.

2 Labelling of device

- The labelling of device shall be

complied with the requirements that

described in SFDA’s guidance

document entitled MDS – G10

Guidance on Labelling

Requirements for Medical Devices.

Clinical investigation agreement between

sponsor and clinical investigation

site(s)/principal investigator(s).

- -

Clinical investigation agreement between

sponsor and CRO.

- If applicable.

IRB approval letter. - It is required for each site

The IRB shall be registered at National Committee of Bio Ethics

mailto:[email protected]

Page 11 of 22

(NCBE).

Clinical Investigation Plan (CIP) - It should be in accordance to ISO

14155:2011

Investigator's Brochure (IB) - It should be in accordance to ISO

14155:2011.

Informed consent - It shall be in Arabic and English.

It should be in accordance with the

ISO 14155:2011

Clinical investigation insurance covering the cost of treatment of subjects.

- if applicable.

Selection report of investigation site - -

Curriculum Vitae of investigator(s) and

sub-investigators.

- -

B. Required document during CIMD

Progress reports. - It shall be submitted by sponsor to

SFDA in yearly intervals.

Any changes to :

Investigator’s Brochure (IB),

Clinical Investigation Plan (CIP),

or

informed consent

See

Annex 2 It shall be submitted by sponsor

without delay but not later than five

calendar days of the occurrence of

the change in “Change Form for CIMD”.

Each change requires a separate

“change form” and IRB approval for

the amendment(s).

Curriculum Vitae of new investigator(s). - if applicable.

Monitoring visit reports. - -

Withdrawal of IRBs approval. - Sponsor shall notify SFDA and

investigators in case of withdrawal

of IRB approval or part of it, within

five calendar days of receiving the

withdrawal notice.

Notification on temporary halting the

clinical Investigation.

- If applicable.

It shall be submitted to SFDA

within:

- five calendar days in case of halting because safety

grounds

- 15 calendar days in case of

reasons other than safety

grounds

Major deviations from the investigational

plan that have a substantial impact on the safety or rights of subjects or on the

robustness or reliability of the clinical data

generated by the investigation.

- It shall be submitted by sponsor to

the SFDA without delay but not later than five calendar days.

Request for device recall and/or device - It shall be submitted, with a

Page 12 of 22

disposition regarding return, repair, or

dispose the device or a part of it.

justification, by:

- sponsor to IRB within 30

calendar days after receiving

the request from the principal investigator

- sponsor to SFDA within 30

calendar days after receiving

the request.

C. Required document at the end of the CIMD

Notification of clinical investigation

termination.

- If applicable.

Premature termination of a clinical

investigation.

- If applicable

It shall be submitted by sponsor

within 15 calendar days of the

termination with justifications of the

reason for terminating the

investigation.

Close-out notification of the investigation. - It shall be submitted by sponsor to

SFDA without delay but not later

than 15 calendar days of the

termination.

Close-out report of the investigation. - It shall be submitted by sponsor to

the SFDA and IRBs without delay

but not later than two months after

the termination.

Investigational device accountability. - -

Clinical investigation report. - It shall be submitted by sponsor to

the SFDA and IRBs without delay

but not later than six months after

the termination.

91 92

93

Page 13 of 22

94

FLOWCHART 95

At end of the clinical investigation,

Submit the required documents


Documents-C).

At end of the clinical investigation,



Documents-C).




[email protected]




[email protected]

During the clinical investigation,



Documents-B).

During the clinical investigation,



Documents-B).






importation license, if needed, to the

applicant’s email within 60 calendar

days.






importation license, if needed, to the

applicant’s email within 60 calendar

days.

Start

End

Sponsor located

outside the KSA

Sponsor located

within the KSA

Organization or

independent individual

Organization or

independent individual

It shall appoint an AR to

to act on his behalf within the KSA

It shall appoint an AR to

to act on his behalf within the KSA

Determine

the

applicant

Determine

the

applicant

The assigned AR The assigned AR

Before applying for approval of a

clinical investigation,

It is required to have:

- an establishment National

Registry Number that is issued

through SFDA’s MDNR, and

- an AR license.


clinical investigation,

It is required to have:

- an establishment National


through SFDA’s MDNR, and

- an AR license.


clinical investigation, It is required

to have an Establishment National


through SFDA’s MDNR.

Independent individuals are

excepted.


clinical investigation, It is required

to have an Establishment National


through SFDA’s MDNR.

Independent individuals are

excepted.

96

Page 14 of 22

97

98

99

100

101

102

103

104

105

ANNEXES 106

107

Page 15 of 22

Annex 1 108

Application Form for CIMD 109

Date Received (For SFDA use only)

CIMD Application Number (For SFDA use only)

1. Status

1.1 Type of submission

First submission

Amendments to previous

submission.

1.2 Aim of Study Pre-marketing approval for

new device

Pre-marketing approval for

new claims

Post-Marketing study

Non Marketing study

1.3 Does this clinical

investigation involve

first in human use?

Yes

No

1.4 Importation license for the investigational

device is required?

Yes No

2. Sponsor Details

2.1 Manufacturer Name

establishment National

Registry Number, that is issued

through SFDA’s MDNR (if

applicable)

Address

Phone

Fax

E- mail

Contact person name

Contact person phone

Contact person e-mail

2.1 AR, if applicable Name




applicable)

AR license number

Address

Phone

Fax

E- mail

Contact person name



2.3 Sponsor, if other than manufacturer

Name

establishment National Registry Number, that is issued

Page 16 of 22


applicable)

Address

Phone

Fax

E- mail

Contact person name



2.5 Person responsible for

completing the

application.

Name

Position

Phone

E-mail

3. CRO Details

3.1 CRO, if applicable Name




applicable)

Address

Phone

Fax

E- mail

Contact person name



4. Sponsorship details

4.1 Type of Sponsorship Commercial

Non-commercial

4.2 Type of sponsor

local manufacturer

AR

Hospital

Independent individuals

Foundation

University or Institution

Other, please specify:

……………………………….

4.3 Type of aid Material support Funding support


………………………………...

5. Investigational Device Information

5.1 Is the device registered

at SFDA?

Yes, Medical Device

National Listing Number

issued through SFDA’s

MDMA is: ………………

………………………….. No, but registered in:

Page 17 of 22

Australia

Canada

Japan

USA

EU


……………………………..…

Not registered anywhere

1.4 Importation license for

the investigational device is required?

Yes

No

5.2 Investigational Device Name

5.3 Device Generic name (if not specified above)

5.4 Alternative name for the device used elsewhere (if

applicable)

5.5 Is the device approved

to be marketed

elsewhere for other use

than intended for this

clinical investigation?

No

Yes, explain:………………

……………………………..…

………………………………..

5.6 Device Category ☐ active implantable devices

☐ anesthetic and respiratory

devices

☐ dental devices

☐ electro mechanical medical

devices

☐ hospital hardware

☐ non-active implantable

devices; ophthalmic and

optical devices

☐ reusable devices

☐ single use devices

☐ assistive products for

persons with disability

☐ diagnostic and therapeutic

radiating devices

☐ complementary therapy

devices

☐ biologically derived devices

☐ healthcare e facility

products and adaptations

☐ Laboratory equipment

☐ Other: ………………..

5.7 Does the device is an

implantable?

No

Yes,

Brief description:……..

……………………

……………………

Is the device intended

to remain permanently in patient:

No

Yes

Page 18 of 22

58 Whether the device

intended to be used for

cosmetic rather than

medical purposes

No

Yes, Select:

A non-corrective

contact lens

An implant for

augmentation, fixation,

or sculpting of body

parts

A facial or other skin filler

Equipment for

liposuction

Surgical laser

equipment

5.10 Does the device

incorporate, as an

integral part or

substance, a medicinal

product in achieving its

primary intended

action?

No

Yes

Brand name of

drug:………………

………………….. Active

ingredient:…………

……………………

……………………

Drug

manufacturer:………

………………….. SFDA Drug

Registration Number (if

Applicable):………...

……………………


incorporate a substance

of animal origin?

No

Yes

Type of tissue, cell, or

substance:……………

………………………

……………………….


incorporate human tissue, cell, or

substance?

No

Yes Type of tissue, cell, or

substance:……………

………………………

………………………


incorporate cells or

substance of microbial

origin?

No

Yes

Type of microorganism:

………………………

………………………

5.14 The intended purpose of the device

5.15 Targeted patient

population as intended

All patient

Specific group of patients

Page 19 of 22

by the manufacturer

Clearly

defined:……….……..

5.16 Nomenclature code

number (if any):

GMDN:…………………….

UMDNS:…………...……...

Other:………………………

5.17 Device classification

based on GHTF

guidance “Principles of

Medical Devices

Classification”

A

B

C

D

5.18 Device Classification

in other countries

Country:……………………

Class:………………………


Class:………………………


Class:………………………

6. Design of Clinical Investigation

6.1 Clinical Investigational

Plan title

Scientific title

Abbreviated title

6.2 Clinical Investigational

Plan (CIP) information

CIP number

CIP date

CIP version

6.3 Clinical investigation

objective(s)

Primary objective(s)

Secondary objective(s)

6.4 Clinical investigation

endpoint(s)

Primary endpoint(s)

Secondary endpoint(s)

6.5 Type of Design

Open-label non-randomized clinical investigation

Randomization,

Randomized controlled

clinical investigation

o Parallel group:

………………………

o Cross over:

………………………

Blinding

Single blinded

Double blinded

Other Comparator used

Placebo

Comparator device,

identify:

………………………

6.6 Subject health status

Healthy volunteers

Patients

Both

6.7 Subjects Gender

Male

Female

Both

6.8 Does this study No

Page 20 of 22

includes vulnerable

subjects?

Yes

6.9 Size of the sample

population

Planned total number of

subjects involved in the clinical

investigation

Planned number of subjects

involved in the KSA

6.10 Number of study centers in the KSA

6.11 Other countries where this clinical investigation is carried

out

6.12 Inclusion / Exclusion Criteria

Reference page in the CIP for inclusion criteria

Reference page in the CIP

exclusion criteria

6.13 Duration of the study

Planned start date

Planned completion date

6.14 Is there a Data Safety

Monitoring Committee

for this study?

Yes

No

7. Investigation Site(s) in the KSA

7.1 Site 1 Name

Address

Phone

E-mail

Name of principal investigator

IRBs name

IRBs address

IRBs phone

IRBs e-mail

Protocol number approved by

HREC/IRB

7.2 Site 2 Name

Address

Phone

E-mail

Name of principal investigator

IRB name

IRB address

IRB phone

IRB e-mail

Protocol number approved by

HREC/IRB

Add

8. Declaration

8.1 I, the sponsor defined in this application, :

undertake that I comply with the Law of Ethics of Research on Living Creatures.

undertake that I will report to the SFDA’s NCMDR, IRBs, and investigators any reportable

Page 21 of 22

adverse event of which I become aware that involves the medical device; without delay but

not later than 10 working days of occurrence. Details on reporting are found in SFDA’s

guidance document entitled MDS – G6 Guidance on Post-Marketing Surveillance.

undertake that I will provide the documents specified in sections (II-B) and (II-C) in

SFDA’s guidance document entitled MDS – G.. Guidance on Clinical Investigations of

Medical Devices.

undertake to notify IRBs and investigators in case of withdrawal of SFDA approval or part

of it, within five calendar days of receiving the withdrawal notice.

undertake, under any request from the IRBs, and SFDA, to response by providing accurate, current, and complete information about any aspects of the study.

declare that all information provided in this application is true and complete.

Name:

Position:

Address:

Date:

Signature:

110

111

Page 22 of 22

Annex 2 112

Change Form for CIMD 113

Date:

CIMD Application

Number:

1. The document type

where the change

occur

2. The original

statement

3. The changed

statement

4. Reason of change

Note: Each change requires a separate change form. 114

115

116