Guidance Document under Medical Device Act 2012 ( Act 737)

These Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following;

a) Medical Device Act 2012 (Act 737); and

b) Medical Device Regulations 2012.

List of guidance documents: 

PRE-MARKET MEDICAL DEVICE REGISTRATION

(GENERAL MEDICAL DEVICE)

Title
Code
Version Number
Published Date
Definition of Medical Device   MDA/GD/0006    First Edition    March 2014 
Rules of Classification for General Medical Device   MDA/GD/0009    Second Edition    9 May 2022 
General Medical Device-Grouping   MDA/GD/0005    Second Edition   30 January 2024
Requirements of Labelling for Medical Devices   MDA/GD/0026    Sixth Edition    21 November 2022 
Essential Principles of Safety and Performance of Medical Devices   MDA/GD/0007    First Edition    March 2014 
Common Submission Dossier Template (CSDT)   MDA/GD/0008    First Edition    March 2014 
Declaration of Conformity (DOC)   MDA/GD/0025    First Edition    February 2016 
Change Notification for Registered Medical Device   MDA/GD/0020    Fourth Edition    21 November 2022 
Guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737)   MDA/GL/MD-01    Third Edition   

    Medical Device Specific Requirements

Medical Face Mask and Respirator   MDA/GD/0033    Third Edition    18th May 2023 
Medical Gas System-Requirements for Registration   MDA/GD/0057    Second Edition    9 February 2023 
Personal Protective Equipment (PPE)   MDA/GD/0058    Second Edition    27 May 2022 
Classification of Rehabilitation, Physiotherapy and Speech Therapy Device    MDA/GD/0061    Second Edition    9 March 2023 

 

PRE-MARKET MEDICAL DEVICE REGISTRATION

( IN-VITRO DIAGNOSTIC (IVD) MEDICAL DEVICE )

Title
Code
Version Number
Published Date
Definition of Medical Device  MDA/GD/0006   First Edition    March 2014 
In-Vitro Diagnostic (IVD) Medical Device Classification System  MDA/GD/0001   Second Edition   December 2020
Product Grouping for IVD  MDA/GD/0054   Second Edition   January 2021
Requirements of Labelling for Medical Devices  MDA/GD/0026   Sixth Edition    21 November 2022 
Essential Principles of Safety and Performance for IVD Medical Device  MDA/GD/0002   First Edition   July 2013
Common Submission Dossier Template (CSDT) of IVD Medical Device  MDA/GD/0004   First Edition   July 2013
Declaration of Conformity (DOC)   MDA/GD/0025    Fourth Edition    February 2016 
Change Notification for Registered Medical Device   MDA/GD/0020   Fourth Edition   21 November 2022 
Guideline on How to Apply for Apply for In-Vitro Diagnostic (IVD) the Medical Device Registration under Act 737 MDA/GL No. 2    

    Medical Device Specific Requirements

  Placement Of HIV Self-Test (HIVST) Kit In Malaysia Market

 MDA/GD/0065  First Edition  19 February 2024

 

ESTABLISHMENT LICENSE

Title
Code
Version Number
Published Date
Good Distribution Practice for Medical Device (GDPMD)  MDA/RR NO. 1  First Revision  1 November 2015
Licensing for Establishment  MDA/GD/0027   Second Edition   23 September 2022
Change of Ownership for Medical Device Registration  MDA/GD/0041  First Edition  December 2016
Guideline on How to apply for establishment License under medical device act 2012 (Act 737)  MDA/GL No. 2    

CONFORMITY ASSESSMENT PROCEDURE AND CONFORMITY ASSESSMENT BODY (CAB)

  Title 
  Code 
  Version Number 
  Published Date 
 Conformity Assessment for Medical Device   MDA/GD/0031  First Edition   October 2017 
Principles of Conformity Assessment of IVD Medical Devices  MDA/GD/0003  First Edition  July 2013
Conformity Assessment Body (CAB) Requirement for Registration  MDA/GD/0023  First Edition   September 2020 

REFURBISHED MEDICAL DEVICE

  Title 
  Code 
  Version Number 
  Published Date 
Refurbished Medical Device Requirements MDA/GD/0060  First Edition  11 February 2022
Good Refurbishment Practice for Medical Device MDA/GD/0029  First Edition  January 2016

ADVERTISEMENT

  Title 
  Code 
  Version Number 
  Published Date 
Code of Advertisement MDA/GD/0032 Second Edition  March 2021
Guideline on Application for Medical Device Advertisement Approval - Requirements MDA/GL/04 Second Edition  

POST MARKET SURVEILLANCE AND VIGILANCE

  Title 
  Code 
  Version Number 
  Published Date 
Complaint Handling MDA/GD/0011  First Edition  June 2020
Distribution Records MDA/GD/0012  First Edition  June 2020
Field Corrective Action MDA/GD/0013  First Edition  June 2020
 Mandatory Problem Reporting  MDA/GD/0014   First Edition  May 2020  
 Medical Device Recall  MDA/GD/0015   First Edition  June 2020  

MEDICAL DEVICE EXEMPTION

  Title 
  Code 
  Version Number 
  Published Date 
Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation MDA/GD/0016  First Edition  April 2017
Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education MDA/GD/0018  First Edition  November 2019
Special Access-Notification-General requirements MDA/GD/0043  Second Edition  May 2020
Special Access – Requirements for Ventilator During Emergency Situation MDA/GD/0056   First Edition  April 2020

Notification for Orphaned Medical Device 

Note: This guidance document is withdrawn on 7 August. Please refer to circular letter No.2/2022 Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities.

MDA/GD/0053   First Edition  January 2020

Notification for Obsolete and Discontinue Medical Device

Note: This guidance document is withdrawn on 7 August. Please refer to circular letter No.2/2022 Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities.

 MDA/GD/0055    First Edition   16 April 2020 
Notification of Custom-made Medical Device  MDA/GD/0064    First Edition   28 February 2023 
Importation of Medical Device for Personal Use MDA/GD/0066 First Edition 30 January 2024

EXPORTATION OF MEDICAL DEVICE

  Title 
  Code 
  Version Number 
  Published Date 
Requirements for Export Permit MDA/GD/0024  First Edition  May 2017
-  -  -
Notification of Export Only Medical Device Note: This guidance document is under revision.  MDA/GD/0051  First Edition  July 2019

GLOBAL HARMONIZATION REGULATORY DOCUMENTS

  Title 
  Code 
  Version Number 
  Published Date 
HARMONISED CLASSIFICATION OF MEDICAL DEVICES IN ASEAN MDA/GD/0062  Second Edition  12 December 2023
 HARMONISED BORDERLINE PRODUCTS IN ASEAN MDA/GD/0063  Second Edition  12 December 2023 

MEDICAL DEVICE POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES

MDA/GD/0067 First Edition 30 January 2024

Last updated:  2 February 2024