XXXXXX Doc. No.

CSD-75830
DOCUMENT : COMMON SUBMISSION DOSSIER Rev. No. 00

TITLE : XXXXXx Eff. Date 01-11-2022

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Common Submission Dossier

according to:
Malaysia Medical Device Act 2012 (ACT 737) and
Medical Device Regulation 2012

XXXXXX

Name Department Date Signature*

Prepared by:

Reviewed by:

Approved by:

DOCUMENT HISTORY
Revisio
Date Description of Changes
n

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Content
1. Introduction.....................................................................................................4
2. References.....................................................................................................4
3. Executive Summary........................................................................................4
3.1 Overview.........................................................................................................4
3.2 Commercial Marketing History.......................................................................4
3.3 Intended use...................................................................................................5
3.4 List of Regulatory Approvals or Marketing Clearances..................................5
3.5 Important Safety and Performance Related Information................................5
3.5.1 Summary Of Adverse Events...........................................................................6
3.5.2 Cells, tissues, irradiating components and medical substances......................6
4. Relevant essential principles and rule used to demonstrate conformity........6
5. DEVICE DESCRIPTION.................................................................................7
5.1 Device description and features.....................................................................7
5.1.1 General Description..........................................................................................7
5.1.2 Photos...............................................................................................................7
5.1.3 Sets and Accessories.......................................................................................8
5.1.4 Principle of Operation.......................................................................................8
5.1.5 Risk Class.........................................................................................................8
5.1.6 Accessories......................................................................................................8
5.1.7 Complete list of configurations of the device to be registered.........................8
5.1.8 Description of key functional elements.............................................................8
5.1.9 Explanation of any novel features....................................................................8
5.2 Intended use...................................................................................................8
5.3 Indications for use..........................................................................................8
5.4 Improper use..................................................................................................9
5.5 Instructions for use.........................................................................................9
5.6 Contraindications............................................................................................9
5.7 Warnings.........................................................................................................9
5.8 Precautions.....................................................................................................9
5.9 Potential adverse effects................................................................................9

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5.10 Alternative therapy..........................................................................................9

5.11 Materials.......................................................................................................10
5.12 Other Relevant Specifications......................................................................10
6. SUMMARY OF DESIGN VERIFICATION AND VALIDATION DOCUMENTS
11
6.1 Declaration of conformity..............................................................................11
6.2 Testing reports..............................................................................................11
6.3 Performance data.........................................................................................11
6.4 Pre-clinical studies........................................................................................11
6.5 Software validation studies...........................................................................11
6.6 Medical devices containing biological material............................................11
6.7 Device expected life.....................................................................................11
6.8 Clinical evidence...........................................................................................11
6.9 Use of existing bibliography.........................................................................12
6.10 Medical device labelling...............................................................................12
6.10.1 Label Positioning............................................................................................13
6.11 Risk analysis.................................................................................................14
6.12 Manufacturer information.............................................................................14

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1. Introduction
This Common Submission Dossier was prepared in order to register the medical
device(s) listed in Appendix 1 “List of Medical Device (Group)”.

2. References
This Common Submission Dossier was prepared based on the requirement of
Appendix_2 Common Submission Dossier Template (“CSDT”) of the Malaysia Medical
Device Regulation 2012.

3. Executive Summary

This paragraph provides:

(a) an overview which covers an introductory descriptive information on the medical
device, the intended uses and indications for use of the medical device, novel
features and a synopsis of the content of the CSDT;
(b) commercial marketing history which covers the list of countries where the medical
device is marketed and the dates of introduction into those countries;
(c) intended uses and indications in its label;
(d) List of regulatory approval or marketing clearance obtained including the
registration status, intended use and indications of the medical device in other
countries with copies of certificates or approval letters from each country and
declaration on labelling, packaging and instructions for use;
(e) Status of any pending applications for regulatory approval or marketing clearance;
and
(f) Important safety and performance related information.

3.1 Overview
The XXXXXX is a

3.2 Commercial Marketing History

The table below lists the countries where the devices have been sold:

Countries

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3.3 Intended use

The XXXXXX is designed to

3.4 List of Regulatory Approvals or Marketing Clearances

The following table lists the main regulatory approvals and marketing clearances
obtained.

Reason for
Reference Agency/ Type of Rejection or
Intended Use Registration Status and date
Regulatory Approval withdrawal (if
applicable)
See Section
UL Certification N.A.
3.3
510(K) Pre-market See Section
N.A.
Notification 3.3
ISO 13485:2016 N.A. N.A.

The medical device is currently registered in

.
The medical device is currently.
The medical device is currently pending registration in Malaysia.
The labelling, packaging, and instructions for use / user manual of the medical device for
sale in Malaysia is identical to that approved by each agency.

3.5 Important Safety and Performance Related Information

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3.5.1 Summary Of Adverse Events

As of this revision of the CDST, there are no records of post-market surveillance
reports relating to the product.
As of this revision of the CDST, there are no records of incidents or near incidents.
As of this revision of the CDST, there are no records of adverse events.

3.5.2 Cells, tissues, irradiating components and medical substances

The device does not contain animal or human cells, nor tissues and/or derivatives
thereof, rendered non-viable. It does not contain cells, tissues and/or derivatives of
microbial or recombinant origin, nor any medical substances.
The devices do not contain irradiating components, ionizing or non-ionizing.

4. Relevant essential principles and rule used to demonstrate

conformity

Appendix A – Essential Principles Conformity Checklist identifies the Essential

Principles that are applicable to the devices and the general rule or method used to
demonstrate confomity to each applicable Essential Principle. The rules or methods used
include compliance with international IEC or EN standards, state of the art or internal
industry methods. The conformity is demonstrated with an Essential Principles
Conformity Checklist in tabular form.

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5. DEVICE DESCRIPTION

5.1 Device description and features

5.1.1 General Description

5.1.2 Photos

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5.1.3 Sets and Accessories

5.1.4 Principle of Operation

5.1.5 Risk Class

The device is an active medical device, since its operation depends on a source of
electrical energy and it acts by converting this energy.
The device is a Class XXXX according to Rule XXXX of the Rules of Classification for
General Medical Devices as specified in Appendix 1 of First Schedule of Medical Device
Regulation 2012, and according to MDA/GD-09: Guidance on the rules of classification
for general medical devices:

5.1.6 Accessories
Refer to paragraph 5.1. above, points 1 and 2.

5.1.7 Complete list of configurations of the device to be registered

See Appendix X - List of Configurations.

5.1.8 Description of key functional elements

Refer to Appendix I – User Manual.
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.1.9 Explanation of any novel features

This device does not present or employ novel features compared to technologies and
functional methods of similar devices already registered and commercialized in Malaysia.

5.2 Intended use

See Section 3.3.

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5.3 Indications for use

Refer to Appendix I – User Manual.
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.4 Improper use

Refer to Appendix I – User Manual.
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.5 Instructions for use

Refer to Appendix I – User Manual..
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.6 Contraindications
Refer to Appendix I – User Manual.
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.7 Warnings
Refer to Appendix I – User Manual.
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.8 Precautions
Refer to Appendix I – User Manual.
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.9 Potential adverse effects

Refer to Appendix I – User Manual.
User Manual, containing Instructions for Use, is identical to that approved by each
reference agency.

5.10 Alternative therapy

Not applicable.

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5.11 Materials

The following items are used

Duration of Physical characterization of

Part´s Type Contact Type
contact the material

5.12 Other Relevant Specifications

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6. SUMMARY OF DESIGN VERIFICATION AND VALIDATION

DOCUMENTS
The verification and validation process relies on the following:

6.1 Declaration of conformity

See Appendix B – Declaration of conformity with Medical Device Act (Act 737) and
Appendix C – UL Declaration of conformity.

6.2 Testing reports

The devices have been tested according to the standards below.

Item Classification and date Document Title

6.3 Performance data

See Appendix X –Report

See Appendix X – EMC Report.

6.4 Pre-clinical studies

6.5 Software validation studies

6.6 Medical devices containing biological material

6.7 Device expected life

6.8 Clinical evidence

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6.9 Use of existing bibliography

See Appendix X– Clinical Evaluation File

6.10 Medical device labelling

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6.10.1 Label Positioning

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6.11 Risk analysis

See Appendix J – Risk Management File.

6.12 Manufacturer information

Manufacturing plant
The plant is located at the following address:

and it is covered by relevant xxxxx certifications (see Appendix X - ISO 13485:2016

Certificate

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