Malaysia: Requirements for Refurbished Medical Device

ARQon
May 6, 2022
2 min read

Updated: May 9, 2022

The Refurbished Medical Device – Requirements Guidance Document was prepared by MDA to aid manufacturers and authorized representatives (AR) in complying with the Medical Device Act (Act 737) when submitting the Notification on refurbishment of medical devices. Note that the Guidance Document should be read in conjunction with existing regulations already in place in Malaysia, which includes

Medical Device Act 2021 (Act 737)
Medical Device Regulations 2012

MDA also has the right to request for additional information and material, or to specify conditions deemed necessary for regulatory control, and to make any amendments to this document in the future. Refurbishment A refurbished medical device is one that is or has parts that are rebuilt, for the purpose it was originally intended for by the product owner. Works carried out on the medical device may include:

Stripping into component parts or sub-assemblies.
Checking suitability for reuse.
Replacement of components/subassemblies not suitable for reuse.
Assembly of the reclaimed and/or replacement components/subassemblies.
Testing of assembled device either against original or revised release criteria.
Identifying an assembled medical device as a refurbished medical device

[source: ASEAN MEDICAL Device Directive 2015]

The Refurbisher is one who refurbishes the medical device. They can either be the manufacturer or a third party refurbisher, who has been given authorization by the manufacturer to refurbish their device.

The route taken for refurbishment depends on the refurbusher, the manufacturer or the third party refurbisher.

Route A is taken when the local manufacturer is the refurbisher. In this case the manufacturer will register the refurbished device through Medical Device Centralised Online Application System 2.0+ (MeDC@St 2.0+). The refurbishment activities must be included under the quality management system (QMS) for the manufacture of medical device.

Route B is taken when the third party refurbisher is placing the refurbished medical device in the market. In this case either the original brand name is used when registering the device, or under the name of the local third party refurbisher. For this, the refurbisher has to obtain an establishment license as a manufacturer from MDA and would be responsible for registration of the device through MeDC@St 2.0+. As such all post market surveillance also falls under the third party manufacturer’s responsibility.

Do note that for both Route A and B, all refurbishment activities shall comply with Good Refurbishment Practice for Medical Devices (GRPMD) and the refurbished medical device must undergo conformity assessment by the Conformity Assessment Body (CAB). All technical details of the device has to be provided. Lastly, labelling of the device has to comply with MDA/GD/0026 Requirements for Labelling of Medical Devices, and include the term “Refurbished”. It shall carry a different catalogue number with suffix [R].

Sources:

MDA/GD/0060: Guidance Document on Requirements for refurbished Medical Device