On January 11 2023, the MDA has announced the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10). This 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.
The key points of this First Edition Guidance Document are as follows:
1. Requirements for Registration.
The manufacturer or the authorized representative is the person responsible for registering a refurbished medical device
| Manufacturer | Authorized Representative |
| Shall obtain establishment license as manufacturer. | Shall obtain establishment license as Authorized Representative. |
| Registration application shall be in accordance with the prescribed registration requirements and shall be submitted through MeDC@St | Registration application shall be in accordance with the prescribed registration requirements and shall be submitted through MeDC@St |
| The refurbishment activities shall be included in the scope of quality management system for the manufacture of medical device – to include GRPMD in scope ISO 13485- clause 7.5 | Shall comply with Good Distribution Practice of Medical Device (GDPMD) – compulsory requirement for clause 28 in GDPMD |
| Refurbishment activities shall comply with Good Refurbishment Practice for Medical Devices (GRPMD) | Refurbishment activities shall comply with Good Refurbishment Practice for Medical Devices (GRPMD) |
| The medical device shall undergo conformity assessment by Conformity Assessment Body (CAB) | The medical device shall undergo conformity assessment by Conformity Assessment Body (CAB) |
| The label of a refurbished medical device shall comply with the requirements as per MDA/GD/0026 Requirements for Labelling of Medical Devices | The label of a refurbished medical device shall comply with the requirements as per MDA/GD/0026 Requirements for Labelling of Medical Devices |
| The medical device labelling shall include the term “Refurbished” and carry a different catalogue number with a suffix of [R] | The medical device labelling shall include the term “Refurbished” and carry a different catalogue number with a suffix of [R] |
2. Conducting Conformity Assessment
Class A medical devices are exempted from the conformity assessment process under the Exemption Order of 2016. Before submitting a registration application to the Authority, medical devices fall under Class B, C, and D must undergo a conformity assessment by an appointed Conformity Assessment Body (CAB).
3. Application Procedure
An application form for the registration of refurbished medical devices must be submitted through the MeDC@St system, which is accessible through the MDA Portal.
| Class of Medical Device | Timeline |
| Class A | 30 days |
| Class B | 60 days |
| Class C | 60 days |
| Class D | 60 days |
5. Table of Fees
a. Application fees
| Class of Medical Device | Application Fee (RM) |
| Class A | 100 |
| Class B | 250 |
| Class C | 500 |
| Class D | 750 |
b. Registration fees
| Class of Medical Device | Application Fee (RM) |
| Class A | – |
| Class B | 1,000 |
| Class C | 2,000 |
| Class D | 3,000 |
Further information on First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10), please refer to this link.
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