孟加拉 IVD 註冊：DGDA 監管與參考國家要求

Mandatory sample testing is typically required during the Step 2 (Final Registration) phase for most high-risk IVDs. DGDA will often send samples to the NCL or a designated government hospital lab. While they are improving cold chain infrastructure, it is your AR's responsibility to coordinate the delivery of samples using validated shippers. While the DGDA reviews your in-house CoA, it does not replace the requirement for local "Analytical Testing" for certain high-volume products (like rapid test kits or specific ELISA assays). If the NCL lacks the equipment for your specific technology, they may accept your validation data, but this must be negotiated during the "Recipe Approval" phase.

This is a major risk in Bangladesh. The Registration Certificate is issued to the local AR, who effectively "owns" the market authorization. To transfer the license or change agents, you must obtain an original NOC signed by the current AR on a stamp paper. If the agent refuses, the DGDA rarely intervenes, often forcing the manufacturer to wait until the 5-year certificate expires to re-register as a "new" application. Therefore, it is highly recommended to appoint an independent third-party regulatory consultant as your AR to maintain control over your license and decouple regulatory ownership from commercial distribution.

在新法案下，软件（SaMD）被明确界定为医疗器械。如果该软件具有独立的临床诊断价值且可以单独销售，则需要独立注册。如果是作为仪器内置的驱动软件，则可以与仪器一同申报。关于云端服务，DGDA 2026 年的最新审查倾向于要求核心诊断逻辑具有可追溯性，虽然目前没有强制要求本地服务器部署，但您必须在技术文件中提供详尽的数据安全协议和临床评估报告，证明其在南亚人群数据上的适用性。

对于 Class C 和 D 的产品，孟加拉国 DGDA 严格要求提供来自参考国（美国、欧盟、加拿大、日本、澳大利亚）的 FSC。仅凭原产国（如中国）的证书是不够的。最关键的是，FSC 原件必须经过孟加拉国驻该参考国使馆的认证。这是目前注册过程中最耗时且容易出错的环节，缺少使馆印章的扫描件将直接导致第二阶段申请被拒绝。

是的，所有 B、C、D 类 IVD 必须强制执行两步审批制。第一阶段即为 Recipe Approval（初审/配方审批），耗时约 3-4 个月。DGDA 在此阶段重点审核产品组成（Master Formula）、包装规格、预期用途以及 CSDT 技术文件的完整性。对于包含多个组分的试剂盒，只要它们属于同一个货号（SKU）或以“系统/成套”形式销售，只需在同一个配方审批申请中列明所有组分的物料清单即可，无需拆分。