This document specifies the requirements and application process for registered and unregistered refurbished medical devices. The application must be applied using the Medical Device Centralised Online Application System (MeDC@St) per this recommendation. Only the manufacturer or an authorised representative (AR) can apply.
The following are the main points of this First Edition Guidance Document:
- 1. Requirements for Registration
|
Manufacturer |
Authorized Representative (AR) |
|
Shall obtain establishment license as Manufacturer. |
Shall obtain establishment license as Authorized Representative. |
|
Registration application as per requirements and submit through MeDC@St. |
Registration application as per requirements and submit through MeDC@St. |
|
The scope of refurbishment activities needs to be included in the scope of the QMS. - to include GRPMD in scope ISO 13485- clause 7.5. |
Shall comply with Good Distribution Practice of Medical Devices (GDPMD). - compulsory requirement for clause 28 in the GDPMD. |
|
Refurbishment activities shall comply with the Good Refurbishment Practice for Medical Devices (GRPMD). |
Refurbishment activities shall comply with the Good Refurbishment Practice for Medical Devices (GRPMD). |
|
Applications undergo conformity assessment by a Conformity Assessment Body (CAB). |
Applications undergo conformity assessment by a Conformity Assessment Body (CAB). |
|
Labels comply with the requirements as per MDA/GD/0026 Requirements for Labelling of Medical Devices. |
Label comply with the requirements as per MDA/GD/0026 Requirements for Labelling of Medical Devices. |
|
The labelling shall include the term “Refurbished” and carry a different catalogue number with a suffix of [R]. |
The labelling shall include the term “Refurbished” and carry a different catalogue number with a suffix of [R]. |
Exclusion: The guidelines in this document do not apply to the remanufacturing of medical devices.
- 2. Conducting Conformity Assessment
All refurbished medical devices in Classes B, C and D must undergo a conformity assessment by an appointed Conformity Assessment Body (CAB) before submitting to MDA. Class A products are exempted under the Exemption Order of 2016.
- 3. Application Procedure
A registration application form for refurbished medical devices must be submitted via the MeDC@St system, which is accessible via the MDA Portal.
- 4. Evaluation Timeline
|
Class of Medical Device |
Timeline |
|
Class A |
30 days |
|
Class B |
60 days |
|
Class C |
60 days |
|
Class D |
60 days |
- 5. Application and Registration Fee
|
Class of Medical Device |
Application fee (RM) |
Registration fee (RM) |
|
Class A |
100 |
- |
|
Class B |
250 |
1000 |
|
Class C |
500 |
2000 |
|
Class D |
750 |
3000 |
Clarification through Visuals:
Figure 1 shows the steps to be taken to register a refurbished medical device
References:
How To Submit An Application For Registration Of A Refurbished Medical Device