This document provides information about the medical device re-registration process in Malaysia. It discusses that re-registration is similar to renewal and requires documents to be submitted to the Conformity Assessment Body before submitting for re-registration. It also outlines the documents needed at different stages, including the Conformity Assessment Body verification, uploading to Medcast 2.0, and common issues like an expired certificate during the re-registration review process. Contacting the officer directly via phone or email is recommended if review is not completed before expiry.

1. Medical Device
Authority
re-registration
(General Medical device only , the situation might be different to IVD)
From my personal experience only, you need not to be agree with me
and for reference purpose only.
The final decision when deal with MDA will depend on MDA.

2. 1. What is re-registration in MDA
Malaysia?
• it is same as renewal, yet the MDA prefer re-registration as the process is similar to
the registration procedure.
• All B, C and D class will have to send the document to CAB before submit the re-
registration
• The button of re-registration of product will appear 6 months (maybe I am not aware
1 year ago before expire [According to Pn. Mariammah it will be 1 year]
• Hence you have to arrange the CAB verification earlier so you will get ready when the
re-registration button appear.

3. 2. Latest ‘Intended Use’ and Existing
‘Intended Use’ registered (No change in
existing IFU)
For my case is , the existing indication/ intended use in origin country had been
extend by ‘adding another part of the bone (for example add hips beside knee)
into the existing Intended use.
When re-registration we stick to the existing intended use , where the submit
latest CSDT and latest IFU document shall content the existing intended use,
and not follow the latest extend existing intended use content.
- We did submit the Classified Change Notification Matter and the officer inform us that the ‘’adding of another
part of the bone’’ is a new Indication, and we shall submit new registration for the product.
- To us it is same thing – just bone, and since the new ‘part of the bone’ has low market thus we stick to existing
Intended-use claims.

4. 3. Document shall prepared for
Re-registration (Stage 1 for –CAB)
CAB
New DoC
New CSDT
Latest ISO 13485
Latest PMS for the past 3 years
Latest CE cert
New list of Configuration
Confirmation on ‘Intended Use’ remain the same or provide Change Notification if there is any changes
Latest IFU
Latest labels (label or box) – remember to include the ‘MDA approval no of product & details of AR/ Importer/
distributor’ (even it is sticker in the reality) to avoid return of application
If there is any change on ‘device classification/ Grouping Configuration’, provide MDA Change Notification Approval
For Combination product( device –drug) – Endorsement letter issue by NPRA
Declare of change notification, if never have any change notification, this letter will be ask by MDA officer as well,

5. 3. Document shall prepared for Re-
registration ( Stage 1 - CAB continue….)
The CAB will request some other document for verification
process
• Current MDA Product licence and Establishment Licence
• Existing CAB report (if you have different CAB)
• Existing DoC
• Existing CSDT
• Existing ISO 13485
• Existing CE cert
• Existing labels (label or box)
* Existing means what you had upload to Medcast 1.0 / 2.0 when you first register.

6. 3. Document shall prepared for Re-
registration ( Stage 2 – after approval from CAB - Medcast 2.0)
Mecast 2.0 – will
need to upload
New DoC 
New CSDT 
Latest ISO 13485 and CE cert 
Latest PMS for the past 3 years 
Latest verification CAB report and Cert of Conformity and CAB Auditor info 
New list of Configuration 
Confirmation on ‘Intended Use’ remain the same or provide Change Notification if there is
any changes

Latest IFU 
Latest labels (label or box) – remember to include the ‘MDA approval no of product & details
of AR/ Importer/ distributor’ (even it is sticker in the reality) to avoid return of application

If there is any change on ‘device classification/ Grouping Configuration’, provide MDA
Change Notification Approval
My case – not relevant

7. 3. Document shall prepared for
Re-registration ( Stage 2 –Medcast 2.0)
Upload all the information submit to CAB into Medcast 2.0
*Important
– update the email address if you blank it you might facing problem to receive the notification email
once the product had been approved
– Latest label/ box design, must include the artwork of sticker ‘MDA Product registration no +
AR/importer/distributor info’
- Letter of declaration for ‘No change Notification submit for the past 5 years’
- All letter DOC / PMS shall follow the latest format post by MDA.
– pay via FPX instead of bank draft as it will direct move to next step

8. Document preparation > CAB Verification > CAB Report and Cert >
Re-registration button > upload all information >
payment for Application Fee >
Return/Re-upload Data (Ding Dong Ding Dong a few times) > Evaluate > Verification >
Approval (Shall wait a few day, need approval) >
Registration Fee payment > Product Cert Able to be collect once receive
email notification
3. Document shall prepared for
Re-registration ( Flow)

9. 4. What you should do if the Cert is
almost expired and the re-
registration is not yet been review?
• I actually face the same problem and call the counter 0300 plenty
time, and it never disappoint us, no one answer at all, and if you are
lucky you might be answer the call. Well, I was lucky once or twice
sometime.
• Instead try this number 0376, this is the general line for registration.
Ask the officer in-charge for your product (normally tell them the last 5 digit of the submission ID) and
get their number or email.
• Direct contact them, this will be the fastest way to get your product
to be review.

10. 5. if the Cert is already expired, the
re-registration is still in progress,
• According to Pn.Mariammah, the import and export activities will not
be able to progress.
• Call and email the officer in-charges

11. FEMES
• https://femes.mda.gov.my/index.php?modload=psr&action=10001
• Introduce FEMES , register.
• Submit your inquiry here, even though it might takes time (at least 7-
30 days) to get answer, but you will get black and white once the
assign personnel answer you.
• This FEMES is more responsive than the helpdesk in the Medcast 2.0
(my personal experience, you need not to be agree with me.)