AHWP/WG1/R001:2012

REFERENCE DOCUMENT

Title: Guidance on Mapping of STED to CSDT

Authoring Group: Working Group 1, Pre-Market Submission and CSDT

Endorsed in: The 15th AHWP TC Meeting

Date: June 7th, 2012

This document may contain privileged information and it only intends to be used for the internal
discussions and circulations within the Asian Harmonization Working Party (AHWP). This document
shall not be quoted or circulated outside AHWP or used for any other purposes. AHWP disclaims any
responsibilities of whatsoever nature to anybody to whom this document is copied or made known.

Copyright © 2012 by the Asian Harmonization Working Party

 AHWP/WG1/R001:2012

Preface

The document herein was developed with participation from AHWP regulatory and industry
representatives and Study Group 1 of the Global Harmonisation Task Force (GHTF). The document is
intended to provide non-binding guidance for use in the regulation of medical devices, and has been
subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use of this document; however,
incorporation of this document, in part or in whole, into any other document, or its translation into
languages other than English, does not convey or represent an endorsement of any kind by the
Global Harmonization Task Force.

1. Introduction:

The Global Harmonisation Task Force (GHTF) has recommended the summary technical
documentation (STED) as a harmonized template for the documentation of evidence of conformity
to the Essential Principles of safety and performance (hereafter referred to as Essential
Principles).

The Common Submission Dossier Template (CSDT) has been endorsed by the medical device
regulatory authorities of ASEAN Member States as the common template for the submission of
device information. It contains elements of the GHTF STED.

2. Purpose:

The purpose of this document is to map the sections of STED to CSDT and provide a brief
comparison of the requirements in the two dossier templates. The mapping and comparison
information serves to strengthen understanding of the similarities and differences between the two
templates and to facilitate the bi-lateral transposition of STED and CSDT product dossiers.

This document is intended for general guidance only.

3. Scope:

The mapping and comparison information presented in this guidance document are based on the
following documents and should be read in conjunction with these documents:
- Guidance on ASEAN Common Submission Dossier Template (CSDT) (final) dated 10 October
2011,
- Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential
Principles of Safety and Performance of General Medical Devices GHTF/SG1/N011:2008 dated
Nov 2008 and
- Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential
Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, GHTF/SG1/NO63
dated 26 March 2010.

4. Overview of CSDT and STED:

The STED is primarily intended to be created from existing technical documentation to provide
evidence to the RA/CAB that the subject medical device is in conformity with the Essential
Principles. It builds on the GHTF regulatory model and is supported by the GHTF principles
including the risk classification system, conformity assessment, Essential Principles and
recognition of standards. The STED reflects the status of the medical device at a particular
moment in time (e.g. at the moment of premarket submission or when requested by a RA for post-
market purposes) and is prepared in order to meet regulatory requirements.

The purpose of the CSDT is to provide one common template acceptable by the medical device
regulatory authorities of ASEAN Member States for submission of device information. Although

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not explicitly stated, it is based on regulatory principles that are similar to that recommended by
the GHTF (e.g. risk-based classification system and Essential Principles). Currently, the CSDT is
mainly intended for the pre-market registration of medical devices but there is flexibility to extend
the submission template to the post- market phase.

The key sections of the 2 template formats are listed in Figure 1. Both template formats share
similar heading sections and requirements. More importantly, they are both built on the GHTF
regulatory model and cater for flexibility of implementation to particular risk classes of devices.

Figure 1: Key sections of the CSDT and STED.

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Mapping of Sections of STED to CSDT:

CSDT CSDT Section Heading Correspond Corresponding Remarks

Section ing STED Section Heading
Section in STED

3.0 Executive Summary Nil Nil STED does not contain the Executive Summary.
The Executive Summary provides an overview of the device
and facilitates the pre-market registration process.
4.0 Elements of the Common 2.0 Contents of the STED
Submission Dossier
Template
4.1 Relevant Essential 9.0 Essential Principles (EP) The requirements are the same.
Principles and Checklist
Method Used to Both template formats require an Essential Principles
4.1.1 Demonstrate checklist that identifies:-
Conformity a) the Essential Principles;
b) whether each Essential Principle applies to the device
Essential Principles and and if not, why not;
Evidence of c) the method(s) used to demonstrate conformity with
Conformity each Essential Principle that applies;
. d) a reference for the method(s) employed (e.g., standard),
and
e) the precise identity of the controlled document(s) that
offers evidence of conformity with each method used.

4.2 Device Description 6.0 Device Description and The IVD STED outlines the characteristics of the IVD that
Product Specification, have to be described in this section.
Including Variants and
Accessories The CSDT is not as specific.

The CSDT does not call for information on previous

generations of device (STED section 6.2).

4.3 Summary of Design 11.0 or 10.0 Product Verification and The verification and validation information required in
Verification and (IVD Validation CSDT includes design aspects. Verification of the

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CSDT CSDT Section Heading Correspond Corresponding Remarks

Section ing STED Section Heading
Section in STED

Validation Documents STED) design may be required for novel products, e.g. the
design rationale for incorporating nanomaterials into
a medical device.

IVD STED incorporates guidance specific to IVD medical

devices, e.g. accuracy of measurements and
analytical sensitivity.

The requirements on pre-clinical studies, clinical

evidence and use of existing bibliography are similar.

4.4 Device Labelling 7.0 Labelling The requirements with regards to labeling are the same.

4.5 Risk Analysis 10.0 or 8.0 Risk Analysis and Control The risk analysis requirements are the same.
(IVD Summary
STED)
IVD STED incorporates risk analysis guidance specific to IVD
medical devices.

4.6 Manufacturer Information 8.0 and 9.0 Design and The requirements are similar.
(IVD STED) Manufacturing Information

4.6.1 Manufacturing Process 8.2 and 9.2 Manufacturing Processes The requirements are similar.
. (IVD STED)

Acknowledgement:

AHWP TC Work Group 1 would like to acknowledge the inputs provided by GHTF Study Group 1 in the mapping and comparison effort.

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