Medical device registrations in Malaysia are valid for five years and must be renewed via the MeDC@St 2.0+ system before they expire. The MDA recommends submitting the re-registration application up to one year before the certificate expiry date, the re-registration function becomes available in MeDC@St exactly one year before expiry. As of 13 July 2026, eligible registrations can use the new Automated Re-Registration Route, which carries forward most existing registration data automatically and requires updates only to specific sections. Certificates that are not renewed are automatically deactivated by MeDC@St upon expiry.
Registration renewal is one of the most predictable obligations in Malaysian medical device compliance. You have five years from the date of registration, and the MDA signals the window clearly by making the re-registration function available in MeDC@St exactly one year before expiry. Despite this, lapsed registrations are more common than they should be, usually because renewal was treated as an administrative task rather than a regulatory one.
In 2026, the process changed significantly. The MDA issued Revision 2 of its re-registration announcement on 10 July 2026, introducing the Automated Re-Registration Route effective 13 July 2026. Eligible manufacturers no longer need to resubmit a full dossier for a straightforward renewal. Understanding the new route, who qualifies, what needs to be updated, and what disqualifies you from using it, is now essential knowledge for any manufacturer with a device registered in Malaysia.
This guide covers the complete renewal process as it stands in 2026, including the new automated route, eligibility criteria, what can and cannot be updated, fees, and the most common renewal mistakes that result in avoidable market access gaps. For context on the original registration process, see our guide on how to register a medical device in Malaysia.
Key Takeaways
- Registrations are valid for five years. The re-registration function opens in MeDC@St exactly one year before the certificate expiry date.
- The MDA recommends submitting renewal applications up to one year before expiry, not in the final months before the deadline.
- MeDC@St 2.0+ automatically deactivates certificates upon expiry if no renewal has been submitted.
- As of 13 July 2026, eligible registrations can use the Automated Re-Registration Route, most data carries forward automatically, with updates required only to specific sections.
- Eligibility for the automated route requires: no pending Change Notification or Change of Ownership application, a valid CAB certificate, and no active rejection, suspension, or cancellation on the registration.
- The registration number stays the same after renewal; the validity period continues from the previous certificate, not from the renewal date.
- Fees under the Medical Device (Amendment) Regulations 2025: Class A RM 500 + RM 750; Class B RM 250 + RM 1,000; Class C RM 500 + RM 2,000; Class D RM 750 + RM 3,000.
- Changes outside the permitted update fields must go through a Change Notification application before re-registration can begin.
Standard Evaluation Route vs Automated Re-Registration Route
From 13 July 2026, two renewal routes are available in MeDC@St 2.0+. The route that applies to your renewal depends on whether you meet the eligibility criteria for the automated route.
The original renewal pathway, available to all registrations regardless of eligibility. The establishment submits a full re-registration dossier through MeDC@St 2.0+, and the MDA evaluates it before issuing a renewed certificate. This route is required for any registration that does not meet the automated route eligibility criteria, for example where a CAB certificate has lapsed or a Change Notification is pending.
Available to eligible registrations from 13 July 2026. Most of the original registration data is carried forward automatically by the system, and only specific sections are open for update. This route gives manufacturers a faster, more predictable renewal pathway for straightforward renewals where no significant changes have been made to the device or its documentation since the original registration. There is no separate regulatory review timeline published for this route; processing speed depends on the completeness of the submission.
Who Qualifies for the Automated Re-Registration Route?
To use the automated route, the registration holder must meet all of the following criteria at the time of application. Failing any single criterion means the standard evaluation route applies instead.
| Valid establishment licence | The Manufacturer Licence or Authorised Representative (AR) Licence must be current and valid |
| No pending CN or COO application | No active Change Notification or Change of Ownership application may be pending for the device in MeDC@St 2.0+ |
| Active registration certificate | The current registration certificate must be active and within one year of its expiration date |
| Original registration pathway | The device must have been registered originally through Full Conformity Assessment or the Verification pathway |
| Valid CAB certificate | A valid Conformity Assessment Body certificate must be in place. If the CAB certificate has expired, it must be renewed before the automated route can be used |
| No active rejection, suspension, or cancellation | The device registration must have no active rejection, suspension, or cancellation status |
| Information accuracy | All submitted information must reflect the latest MDA-approved records for the device |
What Can and Cannot Be Updated in the Automated Route
The automated route is not a blank renewal. The MDA has defined exactly which sections of the application form can be edited and which are pulled directly from the existing approved registration. The permitted fields differ by device class.
| Classification, Product Status, General Information, Device Grouping, Additional Requirements | Non-editable, system-generated from existing record Locked |
| Manufacturer Information (QMS certificate) | Update required, current QMS certificate (ISO 13485, MDSAP, US FDA QMSR, Japan Ministerial Ordinance No. 169, or ISO 9001 for empty gas cylinders only) Required |
| Pre-Market Clearance/Approval | Optional update Optional |
| Labelling | Update required, latest labelling showing the MDA registration number and AR information only Required |
| PMS and Vigilance | Update required, latest post-market surveillance and vigilance records Required |
| Declaration of Conformity | Update required, an updated DoC reflecting the current state of the device Required |
| Classification, Device Grouping | Non-editable, system-generated Locked |
| General Information | Limited fields only, export-only status, combination product status, formulation for devices with active ingredients, poisons, or drugs Limited |
| CSDT, Clinical Evaluation/Performance Reports | Update permitted, updated Clinical Evaluation or Performance Evaluation Report reflecting current PMS data Required if updated |
| CSDT, Labelling | Update permitted, labelling showing registration number and AR information Required |
| CSDT, Risk Analysis | Update permitted, latest risk analysis Required if updated |
| CSDT, Pre-clinical documents (biocompatibility, stability, validation reports) | Not editable through this route, changes require a Change Notification application first Locked |
| Manufacturer Information (QMS certificate) | Update required, current QMS certificate (ISO 13485, MDSAP, US FDA QMSR, or Japan Ministerial Ordinance No. 169) Required |
| Pre-Market Clearance/Approval | Optional update Optional |
| CAB certificate | Editable only if the current CAB certificate has expired, otherwise non-editable Conditional |
| PMS and Vigilance | Update required, latest PMS and vigilance records Required |
| Declaration of Conformity | Update required Required |
Re-Registration Fees (2026)
Fees for re-registration follow the Fifth Schedule of the Medical Device Regulations 2012, as amended by the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], gazetted 11 September 2025. Both an application fee and a registration fee apply.
| Device Class | Application Fee | Registration Fee | Total |
|---|---|---|---|
| Class A | RM 500 | RM 750 | RM 1,250 |
| Class B | RM 250 | RM 1,000 | RM 1,250 |
| Class C | RM 500 | RM 2,000 | RM 2,500 |
| Class D | RM 750 | RM 3,000 | RM 3,750 |
| Combination Product | RM 750 | RM 5,000 | RM 5,750 |
How to Renew Your Registration: Step by Step
The re-registration function becomes available in MeDC@St 2.0+ exactly one year before the certificate expiry date. The MDA recommends submitting at this point, not closer to expiry. Set a calendar alert at 14 months before expiry to begin preparation, and at 12 months to submit. Do not wait until 3 to 6 months before expiry.
Confirm that your registration meets all eligibility criteria for the automated route: no pending Change Notification or Change of Ownership, a valid CAB certificate, no active rejection or suspension, and a current establishment licence. If any criterion is not met, resolve it before proceeding, or plan for the standard evaluation route instead.
If you have any device changes that need to be notified to the MDA, labelling updates beyond the registration number, updated pre-clinical reports, or changes to manufacturing site or intended use, submit and obtain MDA approval for the Change Notification before starting the re-registration. Any change outside the automated route's permitted fields must be approved through CN first.
Prepare the documents required for the applicable update fields: updated Declaration of Conformity (mandatory for all classes), current QMS certificate (ISO 13485, MDSAP, US FDA QMSR, or Japan Ministerial Ordinance No. 169), updated labelling with current registration number and AR details, and the latest PMS and vigilance records covering the past 3 years.
The LAR submits the re-registration application through MeDC@St 2.0+. Under the automated route, the system carries forward non-editable fields automatically. The application must be complete and accurate on first submission. Incomplete or inconsistent applications will be returned.
Upon successful renewal, the MDA issues a renewed registration certificate. The registration number remains the same. The validity period continues from the previous certificate's expiry date, it does not restart from the date of renewal. The renewed registration is valid for a further five years from that date.
Renewal Mistakes That Lead to Lapsed Registrations
If the MDA raises queries and there is not enough time to resolve them before the certificate expires, MeDC@St automatically deactivates the registration. The device can no longer be legally sold in Malaysia until renewal is approved. This is entirely avoidable by submitting at the 12-month window.
A CAB certificate that expires before renewal is submitted means the automated route is not available, unless the CAB field is opened for update because the certificate lapsed. Manufacturers who are not tracking CAB certificate expiry dates alongside their registration expiry dates often discover this at the worst possible moment. Both dates need to be in your compliance calendar.
Changes to pre-clinical documents such as biocompatibility, stability, or validation reports cannot be made through the automated re-registration route. Attempting to include these changes will fail. Any changes outside the permitted update fields must go through a Change Notification and receive MDA approval before the re-registration is submitted.
An active Change Notification or Change of Ownership application disqualifies the registration from the automated route. Manufacturers who try to renew while a CN is pending will be placed on the standard evaluation track. Resolve all pending CN applications before submitting the re-registration.
Updated PMS and vigilance records are a mandatory update field in the automated route for all device classes. Manufacturers who have not maintained an active post-market surveillance system find themselves unable to provide the required 3-year PMS report at renewal time, because the data was never systematically collected.
Renewal Support from TT Medical
TT Medical manages the full re-registration process as your Local Authorised Representative, including monitoring certificate expiry dates, confirming automated route eligibility, preparing required update documents, resolving outstanding Change Notifications before renewal, and submitting the application via MeDC@St 2.0+ well within the recommended window. We track all renewal dates for registered devices as a standard part of our LAR service.
Final Thoughts
Registration renewal in Malaysia is more streamlined than it has ever been, thanks to the Automated Re-Registration Route introduced in July 2026. For eligible registrations, the renewal requires updating a defined set of documents rather than resubmitting a full dossier. But the automated route only works if eligibility criteria are met, and meeting those criteria requires active management of CAB certificates, Change Notifications, and PMS documentation throughout the five-year registration cycle.
The manufacturers who renew without disruption treat renewal as a process that begins 12 to 14 months before expiry, not when the deadline is close. If your registration is approaching renewal and you want to confirm your eligibility for the automated route, speak to our consultancy team.
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