孟加拉醫療器材註冊：兩階段 DGDA 批准與有效期限

You must apply for a No Objection Certificate (NOC) for Samples from DGDA first. This NOC allows you to clear a small number of units through customs solely for "Testing and Registration Purposes." If the NCL lacks the technical capacity to test your device (which is common for Class D), the DGDA Technical Committee will usually request a "Method Validation Report" and may allow the use of your own ISO 17025 accredited lab reports. However, in 2026, DGDA has been increasingly requesting "Sample Analysis" via a local government-designated expert physician to verify the clinical handling of the device before the final Registration Certificate is issued.

In Bangladesh, the AR who holds the Registration Certificate has significant control. Under the current DGDA framework, the AR must issue a Letter of Authorization to individual distributors so they can apply for their own Import Permission (IP) for specific shipments. It is highly recommended to use an independent third-party AR rather than a distributor, because changing the AR in Bangladesh requires a No Objection Certificate (NOC) from the existing representative. Without a clear contract, an uncooperative distributor-AR can effectively block you from re-registering or switching partners.

2023 年法案确实将软件（Software）列入监管。目前 DGDA 将大多数诊断类 AI 划分为 Class C。虽然 DGDA 尚未建立完善的数据安全法，但在注册 Dossier 中，您必须详细说明数据传输协议（Protocol）和隐私保护机制。DGDA 的技术委员会（DCC）在 2026 年的评审中，开始关注软件的“本地化适应性”，即您必须证明该 AI 模型在南亚人群数据上经过验证或具有适用性，否则可能被要求在本地进行小规模临床验证。

根据 DGDA 的“参考国”原则，C 类和 D 类高风险产品必须提供来自参考国（美国、欧盟、加拿大、日本、澳大利亚）的 FSC。由于您的产品是中国制造，您必须提供两份 FSC：一份是原产国（中国）的 FSC，且必须经过孟加拉驻华使馆认证；另一份是上述参考国之一的 FSC。2026 年的最新政策对使馆认证要求非常严苛，任何未经认证的副本在第二阶段评审中都会被退回。

这是一个孟加拉国特有的流程。根据 DGDA 2026 年的实务，所有 B、C、D 类医疗器械必须先经过 Recipe Approval（第一阶段）。对于器械，DGDA 要求提交 "Master Formula" 的简化版，重点在于产品组成部件的详细规格和来源。只有在获得配方审批信后，您才有资格进入第二阶段（正式注册）。如果第一阶段的材料不完整，将无法通过 DGDA 的初审。