This Article Deals about the Submission of Medical Device Application for Registration Published by Medical Device Authority of Malaysia. This manual was created to help the manufacturer and Authorized representative while registering a used medical equipment. A medical device must be registered under the Medical Device Act 2012 (Act 737) according to Section 5(1) before it may be imported, exported, or sold. Refurbished medical devices must be registered via the Medical Device Centralized Online Application System, with the manufacturer or authorized representative in charge.

Requirements for registration

Manufacturer Authorized Representative
Manufacturer must obtain establishment license through MeDC@St.Authorized Representatives must obtain establishment license through MeDCP.
Refurbishment activities must be included in ISO 13485-clause 7.5.GDPMD requires compliance with Good Distribution Practice of Medical Devices.
Refurbishment activities must comply with GRPMD and undergo conformity assessment by CAB.Refurbishment activities must comply with Good Refurbishment Practice for Medical Devices (GRPMD) and undergo conformity assessment by CAB.
The label of a refurbished medical device must comply with MDA/GD/0026 requirements and include the term “Refurbished” and a different catalog number with a suffix of [R].
The label of a refurbished medical device must comply with MDA/GD/0026 requirements and include the term “Refurbished” and a different catalog number with a suffix of [R].

Application Procedure

The MeDC@St system provides an application form for the registration of refurbished medical devices. It is an internet-accessible web-based online application form and requires an account to be set up.

  • The establishment must label the medical devices in accordance with MDA/GD/0026, Requirement for Labeling of Medical Devices, with the registration number and other information. 
  • Any changes must be reported by the establishment via a change notification.
  • For Detailed information please visit the source link attached below.

Evaluation Timeline

Class of Medical Device Timeline
Class A30 Days
Class B60 Days
Class C60 Days
Class D60 Days

Table of Fee

Application Fee

Class of Medical Device Application Fee ( RM )
Class A100
Class B250
Class C500
Class D750

Registration Fee

Class of Medical Device Application Fee ( RM )
Class A–
Class B1000
Class C2000
Class D3000

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Source – Medical Device Authority Malaysia


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