Talian Hotline Kami+603 - 8230 0300

FAQ For Re - Registration

Please apply through the MeDC@St application system. The re-registration button will appear within 1 year prior to expiry date. Please notify through helpdesk in the application system if the button is still cannot be found within the 1 year of expiry.

Registration holder may choose same CAB as previously engaged with or different CAB to do the conformity assessment for re-registration.

No, you do not have to submit change notification if there’s no change notification as per guidance document MDA/GD/0020 Change Notification for Registered Medical Device.

Please provide declaration that there is no change on the device.

You may use the acknowledgement letter until further notify by MDA. Please check for announcement on the MDA portal from time to time.

Same as current registration, the turnaround time is as below:

Class A – 30 days

Class B, C and D – 60 days

Please refer to guidance document on labelling. MDA/GD/0026 Requirements for Labelling of Medical Devices. Please check for announcement on the MDA portal from time to time.

If the classification of the registered medical device changed, applicant is required to submit as new registration application.

Yes, the medical device registration number will remain same if apply for re-registration.

You have to apply for change notification if there is removal of pre-market approval or CE certification. You may continue with reregistration after approval change notification of the removal of the certification.

CAB has to conduct conformity assessment via verification route for re-registration of registered medical device.

Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

+603 - 8230 0300

+603 - 8230 0200

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