馬來西亞醫療器材註冊維護：變更通知 (CN) 流程

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.

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.

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）。

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。

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。