ASEAN Consultative Committee for Standards and Quality
Medical Device Product Working Group
(ACCSQ-MDPWG)
Document Number: N0013
(Name) ACCSQ-MDPWG/Guide 6 Version 1 (16 February
2006)
Date: 16 Feb 2006
Document Title: ACCSQ-MDPWG-Guidance For Common
Submission Dossier Template (Version6), Chiangmai,
Thailand, 14 – 16 Feb 2006
ACCSQ-MDPWG/Guide 6 Version 1 (16 February 2006) Page 1 of 15
1.0 Introduction
The document is intended to provide guidance for submission of device information to the
regulatory authorities; structured in the format of one common template acceptable by all
ASEAN regulators. It is envisaged that a Common Submission Dossier Template (CSDT)
will harmonize the differences in documentation formats that presently exist in different
ASEAN jurisdictions. The adoption of this guidance document in ASEAN will eliminate the
preparation of multiple dossiers, arranged in different formats but with essentially the same
contents, for regulatory submission to different regulatory authorities.
2.0 Scope
This guidance document describes the format for an ASEAN harmonized common
submission dossier template and provides general recommendation on the content of the
formatted elements. This document does not recommend any new or additional technical
documents above and beyond what should be created by the manufacturer to comply with
existing requirements to demonstrate conformity to the Essential Principles [GHTF
SG1/N041], and to address any country-specific requirements.
This document applies to all products that fall within the definition of a medical device1.
Essentially, the CSDT contains elements of the Summary Technical Documentation (STED)
[GHTF SG1/N011R17]2 for demonstrating conformity to the Essential Principles of Safety
and Performance of Medical Devices.
The format of the CSDT recommended herein is based upon the goal of both regulators and
manufacturers to strive for the least burdensome means to demonstrate conformity to the
Essential Principles for all classes of medical devices.
Requirements for post-market vigilance or adverse event reporting are outside the scope of
this document.
1 ACCSQ MDPWG 2nd Meeting, Jakarta, Indonesia, 11-12 July 2005
2 Text in italics in this document are similar to those in the GHTF STED Document
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3.0 Executive Summary
An executive summary shall be provided with the common submission dossier template,
which shall include the following information:
• an overview, e.g., introductory descriptive information on the medical device, the
intended uses and indications for use of the medical device, any novel features and a
synopsis of the content of the CSDT;
• commercial marketing history;
• intended uses and indications in labelling;
• status of any pending request for market clearance; and
• important safety/performance related information.
4.0 Elements of the Common Submission Dossier Template
4.1 Relevant Essential Principles and Method Used to Demonstrate Conformity
The CSDT should identify the Essential Principles of Safety and Performance of Medical
Devices that are applicable to the device. The CSDT should identify the general method used
to demonstrate conformity to each applicable Essential Principle. The methods that may be
used include compliance with recognized or other standards, state of the art or internal
industry methods, comparisons to other similar marketed devices, etc.
The CSDT should identify the specific documents related to the method used to demonstrate
conformity to the Essential Principles.
4.1.1 Essential Principles and Evidence of Conformity
The evidence of conformity can be provided in tabular form with supporting documentation
available for review as required. A sample of the essential principles conformity checklist
is included in Appendix A.
For example, a completed Essential Principles conformity checklist can be used to
demonstrate that a recognized test standard was used as part of the method to demonstrate
conformity to one Essential Principle. As such, CSDT would then include a declaration of
conformity to the standard, or other certification permitted by the Regulatory Authority, and a
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summary of the test data, if the standard does not include performance requirements. When
the manufacturer uses international or other standards to demonstrate conformity with the
Essential Principles, the CSDT should identify the full title of the standard, identifying
numbers, date of the standard, and the organization that created the standard. When the
manufacturer uses other means, such as internal standards, the CSDT should describe the
means.
Not all the essential principles will apply to all devices and it is for the manufacturer of the
device to assess which are appropriate for his particular device product. In determining this,
account must be taken of the intended purpose of the device.
4.2 Device Description (According to GHTF Classification)
Description A B C D
Device Description
Intended Use/Indications for Use
Product Drawing/Product Brochure
Material/Component List
Statement on Shelf Life (Sterile Product
only)
4.2.1 Device description & features
Besides a general description of the device, a more detailed description of the device
attributes is necessary to explain how the device functions, the basic scientific concepts that
form the fundamentals for the device, the component materials and accessories used in its
principles of operation as well as packaging. A complete description of each functional
component, material or ingredient of the device should be provided, with labelled pictorial
representation of the device in the form of diagrams, photographs or drawings, as
appropriate.
4.2.2 Intended use
This means the use for which the medical device is intended, for which it is suited according
to the data supplied by the manufacturer in the instructions as well as the functional
capability of the device.
4.2.3 Indications
This is a general description of the disease or condition that the device will diagnose, treat,
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prevent, cure or mitigate and includes a description of the target patient population for which
the device is intended.
4.2.4 Instructions of use
These are all necessary information from the manufacturer including the procedures, methods,
frequency, duration, quantity and preparation to be followed for safe use of the medical
device. Instructions needed to use the device in a safe manner shall, to the extent possible, be
included on the device itself and/or on its packaging by other formats / forms.
4.2.5 Contraindications
This is a general description of the disease or condition and the patient population for which
the device should not be used for the purpose of diagnosing, treating, curing or mitigating.
Contraindications are conditions under which the device should not be used because the risk
of use clearly outweighs any possible benefit.
4.2.6 Warnings
This is the specific hazard alert information that a user needs to know before using the
device.
4.2.7 Precautions
This alerts the user to exercise special care necessary for the safe and effective use of the
device.
They may include actions to be taken to avoid effects on patients/users that may not be
potentially life-threatening or result in serious injury, but about which the user should be
aware. Precautions may also alert the user to adverse effects on the device of use or misuse
and the care necessary to avoid such effects.
4.2.8 Potential adverse effects
These are potential undesirable and serious outcomes (death, injury, or serious adverse events)
to the patient/user, or side effects from the use of the medical device, under normal
conditions.
4.2.9 Alternative therapy
This is a description of any alternative practices or procedures for diagnosing, treating, curing
or mitigating the disease or condition for which the device is intended.
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4.2.10 Materials
A description of the materials of the device and their physical properties to the extent
necessary to demonstrate conformity with the relevant Essential Principles. The information
shall include complete chemical, biological and physical characterization of the materials of
the device.
4.2.11 Other Relevant Specifications
The functional characteristics and technical performance specifications for the device
including, as relevant, accuracy, sensitivity, specificity of measuring and diagnostic devices,
reliability and other factors; and other specifications including chemical, physical, electrical,
mechanical, biological, software, sterility, stability, storage and transport, and packaging to
the extent necessary to demonstrate conformity with the relevant Essential Principles.
4.2.12 Other Descriptive Information
Other important descriptive characteristics not detailed above, to the extent necessary to
demonstrate conformity with the relevant Essential Principles (for example, the
biocompatibility category for the finished device).
NOTE: For simple, low risk devices, the above information will typically be contained
in already existing sales brochures, instructions for use, etc.
4.3 Summary of Design Verification and Validation Documents
This section should summarize or reference or contain design verification and design
validation data to the extent appropriate to the complexity and risk class of the device:
Such documentation should typically include:
• declarations/certificates of conformity to the “recognized” standards listed as applied
by the manufacturer; and/or
• summaries or reports of tests and evaluations based on other standards, manufacturer
methods and tests, or alternative ways of demonstrating compliance.
EXAMPLE: The completed Table of Conformity to the Essential Principles that a
recognized test standard was used as part of the method to demonstrate conformity to one
Essential Principle. Section 3.0 of the CSTD would then include a declaration of
conformity to the standard, or other certification permitted by the relevant Regulatory
Authority, and a summary of the test data, if the standard does not include performance
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requirements.
The data summaries or tests reports and evaluations would typically cover, as appropriate to
the complexity and risk class of the device:
• a listing of and conclusions drawn from published reports that concern the safety and
performance of aspects of the device with reference to the Essential Principles;
• engineering tests;
• laboratory tests;
• biocompatibility tests;
• animal tests;
• simulated use;
• software validation.
4.3.1 Pre-clinical Studies
Details must be provided on all biocompatibility tests conducted on materials used in a device.
At a minimum, tests must be conducted on samples from the finished, sterilized device. All
materials that are significantly different must be characterized. Information describing the
tests, the results and the analyses of data must be presented.
Complete pre-clinical physical test data must be provided, as appropriate. The report must
include the objectives, methodology, results and manufacturer's conclusions of all physical
studies of the device and its components. Physical testing must be conducted to predict the
adequacy of device response to physiological stresses, undesirable conditions and forces,
long-term use and all known and possible failure modes.
Pre-clinical animal studies used to support the probability of effectiveness in humans must be
reported. These studies must be undertaken using good laboratory practices. The objectives,
methodology, results, analysis and manufacture's conclusions must be presented. The study
conclusion should address the device's interactions with animal fluids and tissues and the
functional effectiveness of the device in the experimental animal model(s). The rationale (and
limitations) of selecting the particular animal model should be discussed.
4.3.1.1 Software Validation Studies (if applicable)
The correctness of a software product is another critical product characteristic that cannot be
fully verified in a finished product. The manufacturer and/or device sponsor must provide
evidence that validates the software design and development process. This information
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should include the results of all verification, validation and testing performed in-house and in
a user's environment prior to final release, for all of the different hardware configurations
identified in the labelling, as well as representative data generated from both testing
environments.
4.3.1.2 Devices Containing Biological Material
Results of studies substantiating the adequacy of the measures taken with regards to the risks
associated with transmissible agents must be provided. This will include viral clearance
results for known hazards. Donor screening concerns must be fully addressed and methods of
harvesting must also be fully described. Process validation results are required to substantiate
that manufacturing procedures are in place to minimize biological risks.
4.3.2 Clinical Evidence
This section should indicate how any applicable requirements of the Essential Principles for
clinical evaluation of the device have been met. Where applicable, this evaluation may take
the form of a systematic review of existing bibliography, clinical experience with the same or
similar devices, or by clinical investigation. Clinical investigation is most likely to be
needed for higher risk class devices, or for devices where there is little or no clinical
experience.
4.3.2.1 Use of Existing Bibliography
Copies are required of all literature studies, or existing bibliography, that the manufacturer is
using to support safety and effectiveness. These will be a subset of the bibliography of
references. General bibliographic references should be device-specific as supplied in
chronological order. Care should be taken to ensure that the references are timely and
relevant to the current application.
Clinical evidence of effectiveness may comprise device-related investigations conducted
domestically or other countries. It may be derived from relevant publications in a
peer-reviewed scientific literature. The documented evidence submitted should include the
objectives, methodology and results presented in context, clearly and meaningfully. The
conclusions on the outcome of the clinical studies should be preceded by a discussion in
context with the published literature.
4.4 Device Labelling
This is the descriptive and informational product literature that accompanies the device any
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time while it is held for sale or shipped, such as any physician’s manuals, pack labeling,
promotional material and product brochures etc. This section should summarize or reference
or contain the following labelling data to the extent appropriate to the complexity and risk
class of the device, which is generally considered as “labelling”:
• Sample of labels on the device and its packaging
• Instructions for use
• Other literature or training materials
• Instructions for installation and maintenance (if applicable).
• Any information and instructions given to the patient, including instructions for any
procedure the patient is expected to perform (if applicable).
4.4.1 Samples of Labels on the Device and its Packaging
This is the printed, written or graphic product information provided on or attached to one or
more levels of packaging, including the outer packaging or the outside container wrapper.
Any pack labelling, which is not provided on the outer packaging must be easily legible
through this outer packaging.
If it is physically impossible to include samples of labels (e.g. large warning labels affixed
onto an X-ray machine), alternative submission methods (e.g. photographs or technical
drawings), to the extent appropriate, will suffice to meet the requirements of this section.
4.4.2 Instructions for Use, Training Materials & Instructions for Installation
and Maintenance
The instructions for use is commonly referred to as the physician’s manual, user manual,
operator’s manual, prescriber’s manual or reference manual. It contains directions under
which the physician or end-user can use a device safely and for its intended purpose. This
should include information on indications, contraindications, warnings, precautions, potential
adverse effects, alternative therapy and the conditions that should be managed during normal
use to maintain the safety and effectiveness of the device. Where applicable, this section
should include instructions for training of the end-users for competent use of the device for
its intended purpose, as well as installation and maintenance of the device.
4.5 Risk Analysis
This section should summarize or reference or contain the results of the risk analysis. This
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risk analysis should be based upon international or other recognized standards, and be
appropriate to the complexity and risk class of the device.
4.5.1 Results of Risk Analysis
A list of possible hazards for these devices must be prepared. Indirect risks from medical
devices may result from device-associated hazards, such as moving parts, which lead to
sustained injury, or from user-related hazards, such as ionizing radiation from an X-ray
machine. The evaluation of these risks against the claimed benefits of the device and the
method(s) used to reduce risk to acceptable levels must be described. The individual or
organization that carries out the risk analysis must be clearly identified. The technique used to
analyze risk must be specified, to ensure that it is appropriate for the device and the risk
involved.
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4.6 Manufacturer Information
This section should summarize or reference or contain documentation related to the
manufacturing processes, including quality assurance measures, which is appropriate to the
complexity and risk class of the device.
4.6.1 Manufacturing Process
Manufacturing process for the device should be provided in the form of a list of resources and
activities that transform inputs into the desired output.
EXAMPLE: The manufacturing process should include the appropriate manufacturing
methods and procedures, manufacturing environment or condition, and the facilities and
controls used for the manufacturing, processing, packaging, labeling, storage of the device.
Sufficient detail must be provided to enable a person generally familiar with quality systems
to judge the appropriateness of the controls in place. A brief summary of the sterilization
method and processing should be included, if any.
If multiple facilities are involved in the manufacture of device, the applicable information
(e.g. quality assurance certificates issued by an accredited third party inspection body) for
each facility must be submitted. Firms that manufacture or process the device under contract
to the manufacturer may elect to submit all or a portion of the manufacturing information
applicable to their facility directly to the Regulatory Authority in the form of a master file.
The manufacturer should inform these contractors of the need to supply detailed information
on the device. However, it is not the intent of this section to capture information relating to
the supply of sub-components (i.e. unfinished medical device) that contributes towards the
manufacture of the finished device itself.
References
SG1/N009 Labeling for Medical Devices
SG1/N015 Medical Devices Classification
SG1/N029 Information Document Concerning the Definition of the Term ‘Medical
Device’.
SG1/N041 Essential Principles of Safety and Performance of Medical Devices
(including In Vitro Diagnostic Devices)
SG1/N043 Labeling for Medical Devices (including In Vitro Diagnostic Devices)
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SG1/N011R17 Summary Technical Documentation for Demonstrating Conformity to the
Essential Principles of Safety and Performance of Medical Devices (STED)
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APPENDIX A - Example of an Essential Principles Conformity Checklist
Essential Principle Applicabl Method of Identity
e to the Conformit of
device? y3 Specific
Documen
ts
1. Medical devices should be designed and manufactured in Yes
such a way that, when used under the conditions and for the
purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of
intended users, they will not compromise the clinical condition
or the safety of patients, or the safety and health of users or,
where applicable, other persons, provided that any risks which
may be associated with their use constitute acceptable risks
when weighed against the benefits to the patient and are
compatible with a high level of protection of health and safety.
2. The solutions adopted by the manufacturer for the design Yes
and construction of the devices should conform to safety
principles, taking account of the generally acknowledged state
of the art. In selecting the most appropriate solutions, the
manufacturer should apply the following principles in the
following order:
• identify hazards and the associated risks arising
from the intended use and foreseeable misuse,
• eliminate or reduce risks as far as possible
(inherently safe design and construction),
• where appropriate take adequate protection
measures including alarms if necessary, in
relation to risks that cannot be eliminated,
• inform users of the residual risks due to any
shortcomings of the protection measures
adopted.
3. Devices should achieve the performance intended by the Yes
manufacturer and be designed, manufactured and packaged in
such a way that they are suitable for one or more of the
functions within the scope of the definition of a medical device
3
Select from: recognised standard/other international standard/national standard/company standard/validated test/ etc.
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applicable in each jurisdiction.
4. The characteristics and performances referred to in Yes
Clauses 1, 2 and 3 should not be adversely affected to such a
degree that the clinical conditions and safety of the patients
and, where applicable, of other persons are compromised
during the lifetime of the device, as indicated by the
manufacturer, when the device is subjected to the stresses
which can occur during normal conditions of use and has been
properly maintained in accordance with the manufacturer’s
instructions.
5. The devices should be designed, manufactured and packed Yes
in such a way that their characteristics and performances
during their intended use will not be adversely affected during
transport and storage taking account of the instructions and
information provided by the manufacturer.
6. The benefits must be determined to outweigh any Yes
undesirable side-effects for the performances intended.
7.1. The devices should be designed and manufactured in
such a way as to ensure the characteristics and performance
referred to in Section I of the 'General Requirements'.
Particular attention should be paid to:
• the choice of materials used, particularly as
regards toxicity and, where appropriate,
flammability,
• the compatibility between the materials used and
biological tissues, cells and body fluids, taking
account of the intended purpose of the device.
• the choice of materials used should reflect,
where appropriate, matters such as hardness,
wear and fatigue strength.
7.2. The devices should be designed, manufactured and
packed in such a way as to minimise the risk posed by
contaminants and residues to the persons involved in the
transport, storage and use of the devices and to the patients,
taking account of the intended purpose of the product.
Particular attention should be paid to the tissues exposed and
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to the duration and frequency of exposure.
7.3. Etc.
8. Etc.
9. Etc.
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