Guidance Documents

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: 

Code  Title  Download 
 MDA/RR NO. 1  Good Distribution Practice for Medical Devices (GDPMD)  Click Here
 MDA/GD/0001  In-Vitro Diagnostic (IVD) Medical Device Classification System   Click Here
 MDA/GD/0002  Essential Principles of Safety and Performance of IVD Medical Devices  Click Here
 MDA/GD/0003  Principles of Conformity Assessment for In- Vitro Diagnostic (IVD) Medical Devices  Click Here
 MDA/GD/0004  Common Submission Dossier Template (CSDT) of In- Vitro Diagnostic (IVD) Medical Device  Click Here
 MDA/GD/0005  Product Grouping  Click Here
 MDA/GD/0006  Definition of Medical Device  Click Here
 MDA/GD/0007  The Essential Principles of Safety and Performance of Medical Devices  Click Here
 MDA/GD/0008  Common Submission Dossier Template (CSDT)  Click Here
 MDA/GD/0009  Rules of Classification for General Medical Devices  Click Here
 MDA/GD/0029  Good Refurbishment Practice of Medical Devices (GRPMD)  Click Here
 MDA/GD/0025  Declaration of Conformity (DoC)  Click Here
 MDA/GD/0027  Licensing for Establishment  Click Here
 MDA/GD/0026  Requirements for Labelling of Medical Devices  Click Here
 MDA/GD/0041  Change of Ownership for Medical Device Registration  Click Here
 MDA/GD/0020  Change Notification for Registered Medical Device  Click Here
 MDA/GD/0016  Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation  Click Here
  Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products Third Edition  Click Here
 MDA/GD/0024  Requirements for Export Permit  Click Here
 MDA/GD/0031   Conformity Assessment for Medical Device  Click Here
 MDA/GD/0018  Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education  Click Here
MDA/GD/0045 REQUIREMENTS FOR APPLICATION OF CERTIFICATE OF FREE SALE (CFS) FOR EXPORT ONLY MEDICAL DEVICES Click Here
MDA/GD/0043 Guidance Document Special Access-Notification-General Requirements Click Here
MDA/GD/0051 GUIDANCE DOCUMENT ON NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE  Click Here
MDA/GD/0053 GUIDANCE DOCUMENT ON NOTIFICATION FOR ORPHANED MEDICAL DEVICE  Click Here
MDA/GD/0056 SPECIAL ACCESS – REQUIREMENTS FOR VENTILATOR DURING EMERGENCY SITUATION  Click Here
MDA/GD/0055 NOTIFICATION FOR OBSOLETE & DISCONTINUED MEDICAL DEVICE  Click Here
MDA/GD/0057 MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION  Click Here
MDA/GD/0012 DISTRIBUTION RECORDS  Click Here
MDA/GD/0014 MANDATORY PROBLEM REPORTING  Click Here
MDA/GD/0011  COMPLAINT HANDLING  Click Here
MDA/GD/0013 FIELD CORRECTIVE ACTION (FCA)  Click Here
MDA/GD/0015 MEDICAL DEVICE RECALL  Click Here
MDA/GD/0023 CONFORMITY ASSESSMENT BODY (CAB) - REQUIREMENT FOR REGISTRATION  Click Here
MDA/GD/0032 ADVERTISEMENT FOR MEDICAL DEVICE RQUIREMENTS  Click Here

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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