馬來西亞醫療器材註冊：MDA 要求、東盟協調與依賴途徑

This is a highly recommended strategy. By appointing an independent third-party AR, you retain control over your registration. The AR holds the device license in the MeDC@St system, and you can indeed link multiple distributors as "authorized sub-distributors" under that single license. Legally, the AR is the primary point of contact for the MDA and is responsible for mandatory Adverse Event (AE) reporting. However, your distribution agreements must clearly state that the distributors are obligated to report any field complaints to the AR within 48 hours for any serious threats to public health to ensure the AR can meet MDA’s strict reporting timelines.

Yes, you are an ideal candidate for the Verification Route. Since you have approvals from recognized reference authorities (US FDA and EU NB), the Malaysian CAB will only perform a "Verification Audit" instead of a full technical review. This typically reduces CAB processing time from 3–5 months down to 1–2 months, and slashes CAB fees by approximately 40-60%. However, you must ensure that the "Product Name" and "Intended Use" approved by the US FDA/CE exactly match your application in Malaysia to remain eligible for this expedited path.

强烈建议您先提交 COP 变更申请。根据 MDA 规定，续展申请通常在证书到期前一年至 6 个月开始，且续展期间系统往往不允许进行重大变更的操作。如果您先完成 COP 审批，更新后的信息将自动带入续展流程。如果合并操作，可能会导致续展审批延迟，甚至在旧证过期时新证尚未下发，从而导致产品在海关滞留。

MDA 基本接受英文的 CSDT 文件和临床报告，无需翻译成马来语。关于临床数据，MDA 通常接受基于国际人群（如高加索或东亚）的研究，前提是您能证明该疾病的病理生理学在马来西亚人群中无显著差异。

这是一个常见的误区。虽然 A 类器械免于“正式注册（Full Registration）”，但它们必须通过 Exemption Notification（豁免通知） 程序。您必须委任一名本地授权代表 (AR)，由其在 MeDC@St 系统中提交技术文件。虽然不需要经过合格评定机构 (CAB) 的审核，但您仍需持有一份由 MDA 签发的“豁免确认函”方可合法进口。此外，您必须保留完整的技术文档（Technical File）以备抽查。