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December 1, 2025

Approximately 5 minutes

Medical Device Registration: The Change Notification(CN)Process

Maintaining Medical Device Registration in Malaysia: The Change Notification (CN) Process

The maintenance of a registered medical device license in Malaysia is governed by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737). Once a device is registered, the local license holder is responsible for ensuring that any changes to the product, its manufacturing, labeling, or supporting documentation are formally reported to the MDA through the Change Notification (CN) process. All CN submissions are made via Malaysia's medical device registration portal, MedC@st 2.0.

Categories of Change Notification (CN)

The MDA classifies changes into three distinct categories, which determine the required submission pathway and timing:

CategoryDescriptionSubmission Requirement
Category 1Major changes that may affect the safety or performance of the device (e.g., changes to intended use, design, or sterilization method).Requires new registration prior to implementation.
Category 2Moderate changes that require MDA review (e.g., changes to labeling, material, or non-fundamental design changes).Requires MDA endorsement before implementation.
Category 3Minor administrative changes (e.g., software UI tweaks, non-substantive labeling changes, administrative updates).Requires notification only; can be implemented immediately.

Change Notification Fees and Timelines

The fees and processing timelines for Category 2 and 3 CN submissions vary based on the change type and the device's risk classification.

Change Notification Fees (RM / USD)

Medical Device Risk ClassCategory 2 Fee (RM)Category 3 Fee (RM)
Class A50 (~$11)30 (~$7)
Class B500 (~$110)30 (~$7)
Class C1,000 (~$220)30 (~$7)
Class D1,500 (~$330)30 (~$7)
Device with Medicinal Product2,500 (~$550)30 (~$7)

CN Processing Timelines

Application TypeTimeline
Single Submission – Category 2 or 330 working days
Single Submission – Combination (Cat 2 + Cat 3)60 working days
Multiple Submissions – Any combination (2 and/or 3)60 working days

Understanding the correct change category and submitting accurate documentation is crucial for continued compliance and seamless market access in Malaysia.

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Questions & Answers (5)

A
Guest

Our company acts as the Authorized Representative (AR) and holds the Establishment License (EL). Since our GDPMD (Good Distribution Practice for Medical Devices) certificate is valid for 3 years, do we only need to interact with the MDA every 3 years for renewal? Also, how does the 2026 fee increase for Class A devices impact our annual license maintenance budget?

ElendiLabs

While the GDPMD certificate lasts for 3 years, you are subject to annual surveillance audits by your CAB to maintain its validity. If the GDPMD certificate is suspended during a surveillance audit, your Establishment License (EL) might be flagged by MDA. Regarding the budget, starting January 1, 2026, the fee structure for Class A devices has shifted significantly (now totaling RM 1,250 per registration). As an AR, you must ensure that your clients (the manufacturers) account for these new costs during their maintenance cycles, as the MDA now uses this revenue to fund more aggressive post-market inspections of AR warehouses.

P
Guest

If we identify a batch defect and decide to initiate a Voluntary Recall (Class II) in Malaysia, do we need MDA's approval before we notify the hospitals, or is it a notification-only process? Furthermore, what specific documentation is required for the "Final Report" to officially close the FSCA case in the MDA's eyes?

ElendiLabs

For a Class II Recall, you must notify the MDA at least 3 days before you initiate the action. You do not need their prior "approval" to act, but you must submit the Initial FSCA Report via MeDC@St. To "Close" the case, you must submit a Final FSCA Report which includes: 1. The total number of affected units imported into Malaysia. 2. Evidence of the "Response Rate" (confirmation from all affected healthcare facilities). 3. Proof of the corrective action taken (e.g., disposal records or software patch logs). 4. A root cause analysis and a preventive action plan (CAPA) to show the MDA that the risk will not recur.

O
Guest

如果我们的医疗器械在马来西亚境外（例如欧洲）发生了严重不良事件，但该型号也在马来西亚注册，我们是否必须向 MDA 报告？具体的报告时限（Timelines）是如何划分的，尤其是针对“公共卫生严重威胁”的情况？

ElendiLabs

是的。即使事件发生在境外，只要该器械在马来西亚有活跃的注册证，您就必须向 MDA 报告，除非该事件已在当地解决且不涉及运往马来西亚的产品批次。报告时限极其严格： • 48 小时内： 针对“严重的公共卫生威胁”（如可能导致群体性死亡或严重伤害的风险）。 • 10 天内： 针对导致死亡或健康严重恶化的事件。 • 30 天内： 针对设备故障或标签缺陷，但尚未导致严重后果的情况。 逾期不报不仅会导致罚款，还可能被吊销企业执照（Establishment License）。

A
Guest

我们的产品注册证将于 2026 年底过期。根据 MDA 的最新要求，我们必须在过期前多久启动续展程序？如果由于合格评定机构（CAB）的审核延迟，导致我们在证书到期时仍未拿到新的注册证，现有的产品是否可以继续在马来西亚海关清关和销售？

ElendiLabs

根据 MDA 2025 年发布的指南，续展申请必须在注册证到期前 12 个月内 提交。MeDC@St 2.0+ 系统具有自动硬性约束：一旦证书过期，系统将自动注销该条目，您将无法进行“续展”，而必须作为“新申请”重新走一遍完整的注册流程（耗时 6-12 个月）。关于销售连续性，只要您在到期前提交了完整的续展申请并获得了 MDA 的“受理确认”，通常允许在评审期间继续销售。但请务必确保护送货物的进口许可证（Import Permit）在有效期内，因为 2026 年起海关清关将与注册证状态实时挂钩。

A
Guest

我们计划对一款 B 类器械进行更新：微调算法是否会被视为“重大变更”而需要重新进行 CAB 审核？

ElendiLabs

在 2026 年推行的“显著性变更（Significant Change）”框架下，如果该算法改动影响了核心临床声明，MDA 甚至可能要求您按新产品重新注册。

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