Malaysia releases new guidance on registration of refurbished medical devices
The Malaysian Medical Device Authority (MDA) has released guidance on the requirements for registering Refurbished Medical Devices (MD/GD/0060). The guidance document provides information on how to register a refurbished medical device before it can be placed in the Malaysian market.
What is a refurbished medical device?
According to the ASEAN Medical Device Directive (AMDD), it is a medical device in its entirety or any part thereof, which has been rebuilt. This “refurbished” medical device is used for the purpose originally intended by the product owner of the original medical device. It may have had the following work carried out on it:
- stripping into component parts or sub-assemblies;
- checking their suitability for re-use;
- replacement of components/sub-assemblies which are not suitable for re-use;
- assembly of the reclaimed and/or replacement components/sub-assemblies;
- testing of the assembled device against either original or revised release criteria; or
- identifying an assembled medical device as a refurbished medical device.
In essence, a refurbished medical device is one that has been taken out of service and specially processed to be reused.
How to register refurbished medical devices in Malaysia?
There are two routes to register refurbished medical devices in Malaysia, one for the original manufacturer and one for third party refurbishers:
- ROUTE (A) is applicable for refurbished medical devices where the refurbishment is conducted by the Manufacturer. A local manufacturer using their Establishment License or a foreign manufacturer using a Local Authorized Representative shall register the medical device via Medical Device Centralized Online Application System (MeDC@St). The refurbishment activities must be included in the scope of the quality management system for the manufacture of the medical device.
- ROUTE (B) is applicable to Third Party Refurbishers who place a refurbished medical device in the market. A Third Party Refurbisher means any person who is authorized by the manufacturer to refurbish a medical device. Third Party Refurbishers must obtain a Letter of Authorization from the original manufacturer to be able to carry out refurbishment activities. In cases where the Third Party has been sub-contracted by the manufacturer, the original brand name of the device must be used for registration. Otherwise, the Third Party is considered to be a manufacturer so the device must be placed in the market under the Third Party’s name. A local Third Party Refurbisher using their Establishment License or a foreign refurbisher using a Local Authorized Representative shall register the medical device via Medical Device Centralized Online Application System (MeDC@St). All Post-Marketing Surveillance responsibilities fall under the scope of the Third Party Refurbisher.
Both the manufacturer and the third party refurbisher must:
- ensure that their refurbishment activities comply with Good Refurbishment Practice for Medical Devices (GRPMD) – see below
- provide technical details for the refurbished medical device
- ensure that each refurbished medical device must:
- undergo conformity assessment by a Conformity Assessment Body (CAB). Please note that ALL CLASSES of refurbished medical device, A, B, C and D must undergo conformity assessment
- be labelled correctly according to the Requirements for Labelling of Medical Devices (MD/GD/0026). The label must include the term “Refurbished” and carry a different catalogue number with a suffix of [R].
What is Good Refurbishment Practices for Medical Devices (GRPMD) certification?
GRPMD is a set of standard operating procedures and dedicated quality requirements that ensure a refurbished medical device is as safe and effective as when it was new.
The MDA issued a Guideline for Good Refurbishment Practice of Medical Device (GRPMD) in January 2016, MDA/GD/0029, which describes the process for refurbishing medical devices.
All local manufacturers and local Third Party Refurbishers (ie those physically present in Malaysia) must obtain GRPMD certification from a Conformity Assessment Board (CAB) in Malaysia prior to refurbishing any medical device. For foreign manufacturers and foreign Third Party Refurbishers their quality management system must be compliant with GRPMD.
For more information:
If you have any queries regarding the registration of medical devices or refurbished medical devices, please contact your Regulatory Affairs Specialist at Andaman Medical or click the button below.