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 Second 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 |
