Malaysia: First Edition Guideline Document MDA/Gl/08: Re-Registration Of Registered Medical Device
First edition guidance on the re-registration of registered medical device was issued by the Ministry of Health Malaysia on 3 June 2022.
The Medical Device Authority (MDA) published the guidance document to provide information and explanation to the establishment on how to submit re-registration of registered medical device application under Act 737 and MDR 2012 and prescribes requirements for re-registration of registered medical devices for near expiry or expired medical device registration applications.
The re-registration process of medical device shall undergo the following two stages as below:
- Stage 1: Application for conformity assessment conducted by Conformity Assessment Body (CAB).
The conformity assessment procedure will be conducted by CAB for Class B, C and D excluding Class A medical device. Prior to re-registration of registered medical device via MeDC@St, registration holder shall apply for conformity assessment as elements stipulated in Third Schedule of MDR 2012.
- Stage 2: Application for re-registration of medical device via MeDC@St.
All application for re-registration shall be submitted through the MeDC@St application system where the re-registration button will appear within 1 year prior to expiry date. If there is any change notification has been submitted and obtained approval from the MDA, the re- registration button can be found on the completed change notification application. The re-registration button will not appear if the change notification application is incomplete.
In addition, any changes shall be submitted or notified to the MDA and obtained approval prior to re-registration application. No changes can be made during the submission of re-registration application unless it has been approved under Change Notification application as per prescribe in the guidance document MDA/GD/0020 Change Notification for Registered Medical Device otherwise the re-registration application well be returns or rejected by the MDA.
To make it clear is, change notification letter issued by MDA (if applicable) shall be submitted. If no changes, please provide letter there is no change notification on the device.
The Re-registration Requirement and Process Flow can be referred to Figure 1 from the new Guideline Re-registration of Registered Medical Device (MD/GL/08). For details of each process, can be referred to Table 1 where it explains the steps to be taken before making an application for registration of a medical device.
Applicants are advised to renew all certificates submitted shall be within validity period such as the ISO 13485, the new conformity assessment certificate and report, date of last audit as stated in latest Post-market surveillance and vigilance, and updated Declaration of Conformity.
For the application fee for medical device registration and registration fee for medical device registration can be referred in Table 2 and Table 3 respectively, from the new Guideline Re-registration of Registered Medical Device (MD/GL/08). Overall, the application and registration fee is remains the same as new registration. And the timeline for Class A is 30 working days, while for the Class B, C and D is 60 working days.
The First edition of MDA/GL/08 will benefit the applicants with clear guidance on how to submit re-registration of registered medical device application under Act 737 and MDR 2012. This can expertise re-registration application approval, save time and money.
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