A. Introduction

Importation and placement of a medical device in the Malaysian market requires the medical device to comply with the requirements of the Medical Device Act 2012 (Act 737), and the medical device shall be registered with the Medical Device Authority (MDA) under Section 5 of Act 737. However, the Medical Device (Exemption) Order 2024 has provided an exemption from medical device registration and establishment license requirements for importation of personal use medical devices.

B. Scope of Exemption

The exemption applicable to personal use medical devices under the Medical Device (Exemption) Order 2024 are as follows:

1. Exemption from registration of medical devices

According to the Medical Device (Exemption) Order 2024, medical devices for the purpose of personal use have been exempted from the requirement for registration of medical devices under Section 5 of Act 737.

2. Exemption from establishment license

A person who imports medical devices for the purpose of personal use is exempted from the requirement of an establishment license under Section 15 of Act 737.

C. Definition of Personal Use Medical Device

A medical device which is brought into Malaysia for the use of a particular individual only and not to be placed in the market or be used by a third party.

[SOURCE: Medical Device (Exemption) Order 2024

NOTE:  Refers to Section 43 in the Act 737 for explanation on a third party.

D. Requirements for Importing or Purchasing Personal Use Medical Devices

1. Medical devices for personal use may be imported or purchased subject to the following requirements:

     a) The medical device shall be for the use of immediate family, and not for commercial purposes, resale, and distribution.

          NOTE:  Personal use medical devices must be purchased by an individual (under their own name) and cannot be purchased by an                                              establishment or organization

     b) To provide a formal prescription or letter of recommendation on the professional use medical device(s) from a registered                            healthcare professional, upon request from the Authority.

            NOTE: Certain types of medical devices may not require recommendation from healthcare professionals.

            Refer Annex A for examples.

     c) for medical devices shall be appropriate according to the type of the medical device and there are a few examples as specified in             Attachment 1 as reference.

         NOTE:

         Low/medium risk medical device (eg: Glucose Monitoring, Hearing Aids, In-vitro diagnostic products) : 1 piece of each type.

         Consumable medical device (eg: contact lens, In-vitro maintenance test strips ) : Quantity for 3 months supply.

      d) all labels and labelling information that comes with the medical device shall be retained; and

      e) no same or similar medical device(s) is/are registered in Malaysia

          NOTE: Please refer to Medical Device Authority Register (MDAR) : https://mdar.mda.gov.my

2. The importation of medical devices for the purpose of personal use is also exempted from the requirements of import permit under Customs (Prohibitions of Imports) Order 2023.

E. Regulatory Framework for Importation of Personal Use Medical Device

Any disputes or inquiries can be submitted via email to exemption.bhai@mda.gov.my or contact our representative, Pn. Nur Aisyah at 03 8230 0253

F. EXAMPLES AND SITUATIONS:  Examples and Situations of Personal Use Medical Device

Date of upload: 22 December 2025

Prepared by: Policy and Strategic Planning Division 

Uploaded by: Corporate Communication Division

Please click link to view list of device studies tracker as below: 

https://docs.google.com/spreadsheets/d/1BR9xYVYDdvv2mi0QO7pp1r4NIeyHn18Qv3mf0AhylSI/edit?usp=sharing

Updated: 29th March 2023 

Definition : Medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable.

** Essential Requirement:   Adhere to this prior to submission -(click here)-

1. Notification form : Medcast

2. How to create Medcast Account : Medcast – Notification Creation

3. Administrative Charge : RM 300 

4. Post handling : Disposal of medical device for special access Form

5. Guidance Documents :   Special Access – Notification – General Requirements. "Document under revision"

6. Any inquiries, Please email to  sa.cm@mda.gov.my

7. Contact No. relevant Officer

• • Puan Haidar Nadirah Bt Hawalig +603-8230 0250
  • Puan Nur Maizura Bt Zarmani +603-8230 0339
  • Puan Aidahwaty Bt Ariffin +603-8230 0341 
  • En. Aznil  (Printing Officer) +603-8230 0247  

Process flow:

Importance Notice :

1. Please be advised that Special Access route is strictly for medical devices required in certain situations especially when no suitable registered alternative is available. Applications that do not meet these criteria or lack proper justification will be rejected.

2. To qualify for Special Access Notification, all applicants must possess a valid establishment license, specifically as an Authorized Representative and Importer. 

3. Effective from September 1, 2023, strict adherence to the essential requirement is mandatory. Applications that do not align with these stipulations might face rejection. In the event of an application being returned, the designated time frame for resubmission is limited to 7 working days.

Updated: 8th October 2025

Custom made Criteria :

1. Designed and manufactured according to a written prescription from a qualified medical practitioner for the sole use of a particular patient.

2. Does not fall into the category of mass-produced medical devices that require adaptation for specific professional user requirements.

** Medcast form requirement: - Crucial to adhere (click here) -

How to apply?

A. Notification form : Medcast

B.  How to create Medcast Account : Medcast – Notification Creation

C. Administrative Charge : RM 300

D. Guidance Documents : NOTIFICATION OF CUSTOM-MADE (MDA/GD/0064)

E. Any inquiries, please email to  sa.cm@mda.gov.my 

F. Contact No. relevant Officer:

1. Puan Haidar Nadirah Bt Hawalig +603-8230 0250
2. Puan Nur Maizura Bt Zarmani +603-8230 0339
3. En. Mohamad Aznil bin Ahmad Azmi (Printing Officer) +603-8230 0247

Process flow:

  Importance Notice :

1. Kindly note that commencing 1 December 2023, all submissions for Custom Made Medical Device Notifications are required to be made through the MeDC@St 2.0 online platform. The application processing period is 14 working days upon receipt of a complete application. 

2. The Custom-Made Notification System is activated using earlier version of Medcast 2.0. Users may face system bugs, but rest assured, it won't impact your application's submission. Applicants are advised to refer the Medcast Form Requirement to prevent any potential issues. If you encounter unresolved issues, please reach out to the MDA officer for assistance.

Updated: 8th October 2025