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October 16, 2025

Approximately 5 minutes

Bangladesh IVD Registration: DGDA Regulation and Reference Country Requirements

Bangladesh IVD Registration: DGDA Regulation and Reference Country Requirements

The registration of In Vitro Diagnostic (IVD) devices in Bangladesh is regulated by the Directorate General of Drug Administration (DGDA), operating under the Ministry of Health. This framework was formalized by the Drugs and Cosmetics Act, 2023, which explicitly includes IVD reagents and software within its definition of a medical device.

Classification and Validity

IVD devices are classified into four risk categories (A, B, C, D) following the principles of the ASEAN Medical Device Directive (MDD).

  • Class A Licenses (Low Risk) do not expire.
  • Class B, C, and D Licenses are valid for 5 years and are renewable.

The Mandatory Two-Step Registration Process

Applications for new Market Authorization Certificates for Class B, C, and D IVD devices are subject to a mandatory two-step review process by the DGDA, which typically takes 4–6 months to complete:

1. Primary Review (Recipe Approval)

The initial phase focuses on checking the completeness of all submitted technical and administrative documents. Upon successful review (3–4 months), the DGDA issues a 'Recipe Approval' letter.

2. Final Registration

This phase involves the full, in-depth review of the application and the submission of original, authenticated documents, including the Certificate of Free Sale (CFS) and ISO 13485.

Reference Country Documentation Requirements

The required documentation depends heavily on the device's risk class:

IVD ClassRisk LevelRequired DocumentationAttestation Requirement
Class A/BLow/Medium-LowCertificate of Free Sale (CFS) from the Country of Origin.Original CFS must be attested by the Bangladesh Embassy.
Class C/DMedium-High/HighCFS and ISO 13485 Certificate from a Reference Country.Both CFS and ISO 13485 must be attested by the Bangladesh Embassy.

Reference Countries accepted by the DGDA include the European Union (EU), the United States (USA), Canada, Japan, and Australia.

Local Representation and License Transfer

Foreign manufacturers are required to appoint a single Local Authorized Representative/License Holder to submit the application and hold the registration.

  • Importing: The License Holder does not need to be the physical importer; the manufacturer can work directly with distributors for importation. However, the License Holder must issue a No Objection Certificate (NOC) for each importation.
  • License Transfer: Transferring a license to a new License Holder is possible but requires the original registration certificate, which is typically held by the current License Holder. Without the original certificate, a new registration is necessary.

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Questions & Answers (5)

P
Guest

For our B/C/D class IVD reagents, we understand that DGDA requires sample submission. Is mandatory testing conducted at the National Control Laboratory (NCL) for every batch, or only once during the initial registration? If our reagents require strict cold chain ($-20$°C), how does DGDA ensure the integrity of the samples during their internal testing process, and will they accept our in-house Certificate of Analysis (CoA) in lieu of local testing?

ElendiLabs

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.

A
Guest

We intend to appoint a local distributor in Dhaka as our Authorized Representative (AR). If we decide to terminate our partnership with this distributor in the future, how difficult is it to transfer the registration certificate to a new agent? Does DGDA require a No Objection Certificate (NOC) from the current holder, and what happens if the current agent refuses to provide it?

ElendiLabs

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.

A
Guest

我们的 IVD 系统配备了一套独立的 AI 影像辅助分析软件（SaMD）。根据 2023 年 9 月生效的《药品与化妆品法案》，软件已被正式列入定义。请问软件是否需要独立于硬件进行单独注册？如果软件仅作为云端服务（SaaS）提供，DGDA 是否要求我们在本地服务器进行部署，还是可以接受跨境数据传输？

ElendiLabs

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。

Z
Guest

我们公司位于中国，产品已获得中国 NMPA 证书和 CE 认证。在孟加拉国注册高风险的 C 类或 D 类 IVD 时，DGDA 是否会强制要求提供来自其认可的“参考国”（如美国 FDA、澳洲 TGA 或欧盟成员国）的自由销售证明（FSC）？此外，这些原件是否必须经过孟加拉国驻该国使馆的领事认证（Attestation）？

ElendiLabs

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。

A
Guest

我们计划在孟加拉国注册一款 Class C 的核酸检测试剂盒。在提交正式注册（Final Registration）之前，是否必须先通过“Recipe Approval”？这一阶段主要审核哪些文件？如果我们的试剂盒包含多个组分（如提取液、扩增试剂、酶），是否需要为每个组分分别进行配方审批？

ElendiLabs

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。

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Bangladesh Medical Device Registration: Two-Step DGDA Approval and Validity

Medical device registration in Bangladesh is governed by the **Drugs and Cosmetics Act, 2023**, under the **DGDA**. The process for Class B, C, and D devices is a **two-step approval** (Primary Review and Final Registration), typically taking 4-6 months. All Class B-D licenses are valid for 5 years and require **ISO 13485** and a local authorized representative.

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