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Malaysian Medical Device Registration Requirements

N

nurhakim

#1
Hi there,

I am in need of important information regarding the medical device registration in Malaysia:

a) CSDT-do we need to have a different set for MDA? The one that I have is a Technical File.

Thanks in advance for those who can help.:thanks::thanks:

Regards,
Nur
 
#2
Re: Malaysian Medical Device Registration

You need to fulfill the requirements of the CSTD template.
The supporting documents will come from your technical documentation.
You will also need to supply a copy of your QMS certification, an attestation and a Declaration of Conformity.
 

Murni Ahmad

Involved In Discussions
#3
Hi,

A quick tip. Rearrange your technical file into CSDT.


The contents are the same, with some additional country specific requirements such as

Declaration of Conformity
Declaration of Labeling of product placed in Malaysia
Attestation of Management Representative

Murni
 
N

nurhakim

#4
Thank you Murni.

Murni, does it means that I need to incorporate my Tech File into a CSDT? Should the title be changed too?

I am a newbie here and is arranging for registration of medical device.
 

Murni Ahmad

Involved In Discussions
#5
Thank you Murni.

Murni, does it means that I need to incorporate my Tech File into a CSDT? Should the title be changed too?

I am a newbie here and is arranging for registration of medical device.
Hi Hakim,

Peace be upon you.

Yes you may want to change the title.


Sharing my note on preparing Malaysia CSDT;

6 Elements of CSDT for ABC system.
6.1 Executive summary
-regulatory approvals and commercial marketing history
6.2 Relevant essential principles and rule used to demonstrate conformity
- provide EP checklist and DOC
6.3 Description of medical device
- provide manuals,ifu
6.4 Summary of design verification and validation documents
6.4.1 Pre-clinical studies
-biocompatibility/preclinical test/preclinical animal studies
6.4.2 Software validation studies
-software validation report
6.4.3 Medical devices containing biological material
-details are requested in guidance 3.too long to type....haha
6.5 Clinical evidence
-Clinical evaluation report
6.6 Use of existing bibliography
-clinical papers
6.7 Medical device labelling
-sample of labelling, IFU, manuals.
6.8 Risk analysis
-Risk management report/analysis
6.9 Manufacturer information
-Manufacturing process, QMS certification.
APPENDIX A – Essential Principles Conformity Checklist - MDA template
APPENDIX B – List of configurations of medical device to be registered - MDA template from MedC@st
 
#6
Thank you Murni.

Murni, does it means that I need to incorporate my Tech File into a CSDT? Should the title be changed too?

I am a newbie here and is arranging for registration of medical device.

Yes Murni the CSTD will contain certain information copied from your technical documentation/technical file. Name this file 'Common Submission Dossier' (CSD).[FONT=&quot][/FONT]
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#7
Hello,

I am trying to get Malaysian essential principals checklist and DOC templates, but am unable to find them anywhere (including the MDA website). Could someone please provide me with these templates in word format?

Thank you,
Rashmi
 
#8
Hello,

I am trying to get Malaysian essential principals checklist and DOC templates, but am unable to find them anywhere (including the MDA website). Could someone please provide me with these templates in word format?

Thank you,
Rashmi
Hi Rashmi,

The DOC Template is included in MDA/GD/0025 (page 6-7). For EPSP, you may refer to MDA/GD/0007.

Hope this helps.
 
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