Malaysia MDA Registration Renewal: Renewal vs. Re-Registration

According to Malaysia’s Medical Device Act 2012 (Act 737), a medical device registration certificate is valid for 5 years. To ensure the continued lawful distribution of products in the Malaysian market, the registration holder must apply to the Medical Device Authority (MDA) for Re-Registration before the certificate expires.

According to the MDA’s Guideline for Re-Registration of Registered Medical Device (MD/GL/08), all renewal applications must be submitted through the upgraded online system, MeDC@St 2.0+. The system will automatically activate the “Re-Registration” button exactly one year before the registration certificate expires. Registration holders should initiate the application as early as possible during this window.

So, how exactly does the re-registration process work? This article explains the applicable regulations, application process, fees, review timelines, and document requirements.

1. Applicable Regulations

• MD/GL/08 – Guideline for Re-Registration of Registered Medical Device
• MDA/GL(CAB)/MDRR – Guideline for CAB on Re-Registration of Registered Medical Device (First Edition)

2. Re-Registration Process

The MD/GL/08 guideline provides a detailed re-registration procedure, as shown in the flowchart below:

As shown in the flowchart, re-registration also requires CAB assessment. The registration holder may choose either the original CAB or a different CAB.

The process can generally follow the Product Verification (PV) simplified pathway, followed by submission to MDA, payment of the applicable fees, and MDA review. Once the application is approved, the registration fee must be paid before the new registration certificate is issued. The new certificate remains valid for 5 years.

Key Timeline Requirements

Re-Registration button activation:
The “Re-Registration” button will automatically appear in the system one year before the registration certificate expires. Applications can only be submitted once the button becomes available.

Latest submission date:
The application must be submitted no later than the expiry date of the existing registration certificate.

Recommended submission time:
MDA recommends that registration holders submit their applications as early as possible once the button becomes available. In practice, it is advisable to submit at least 3–6 months before expiry to avoid delays caused by system issues, document deficiencies, or additional information requests.

3. Re-Registration Fees

For Class A medical devices, new fee requirements have applied since January 1, 2026. MDA introduced the revised Class A registration fees through the Medical Device (Amendment) Regulations (P.U. (A) 330) published in September 2025.

There have been no changes to the fees for Class B, C and D medical devices. Re-registration fees are the same as the applicable initial registration fees, as follows:

Notes:

1. For medical devices incorporating medicinal substances, the registration fee is RM5,000, with a total MDA fee of RM5,750.
2. Fees for Class B, C and D devices do not include CAB fees. CAB fees vary depending on the selected CAB and conformity assessment pathway.
3. The above amounts are official government fees only and do not include Authorized Representative fees, regulatory consulting fees, or other service charges where applicable.

4. Re-Registration Review Timeline

According to MDA’s official guideline, the review timeline for re-registration is the same as that for initial registration:

Notes:

The above timelines refer to the MDA review period.

For Class B, C and D medical devices, because CAB conformity assessment is required, the CAB assessment under the PV pathway generally takes around 1–2 months, depending on the selected CAB.

The actual timeline may vary depending on the quality and completeness of the submitted documents, CAB assessment efficiency, and whether additional information or corrective actions are requested.

Recommendation

Registration holders are advised to begin preparing for re-registration approximately 6–9 months before the certificate expiry date to allow sufficient time for CAB assessment, MDA review, and potential requests for additional information.

5. Document Requirements

The main documents required for re-registration include:

• Basic Medical Device Information
• Conformity Assessment of Quality Management System (QMS)
• Conformity Assessment of Post-Market Surveillance System
• Conformity Assessment of Technical Documentation — mainly CSDT
• Conformity Assessment of Declaration of Conformity (DoC)

For detailed requirements, applicants should refer to:

• MD/GL/08 – Guideline for Re-Registration of Registered Medical Device
• MDA/GL(CAB)/MDRR – Guideline for CAB on Re-Registration of Registered Medical Device

Important Reminder: What Happens If You Miss the Re-Registration Deadline?

It is important to note that once the registration certificate expires, the MeDC@St 2.0+ system will automatically deactivate the certificate.

After expiration, the system will no longer allow the registration holder to submit a re-registration application, including applications that were created as drafts but had not yet been submitted before the expiry date.

If the re-registration deadline is missed, the registration holder will have to submit an entirely new registration application and undergo the applicable conformity assessment requirements under Act 737. This can result in significantly higher time and financial costs.

Therefore, early planning and timely submission are critical to maintaining uninterrupted market access in Malaysia.

For medical device manufacturers and registration holders, re-registration should not be treated as a last-minute administrative renewal. Starting preparations well in advance can help ensure sufficient time for CAB assessment, document updates, MDA review, and potential corrective actions, thereby minimizing the risk of registration interruption.