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Bangladeshi Medical Device Regulatory Authority

Medical device registration in Bangladesh is administered by the Directorate General of Drug Administration (DGDA). The DGDA is primarily responsible for developing regulations, managing market access, approving import licenses, and conducting post-market surveillance for medical devices.

DGDA official website: https://dgdagov.info

Database link: https://dgdagov.info/index.php/information-center/registered-medical-device-list

Regulatory Framework

Drugs Act 1940

Drug (Control) Ordinance 1982

The Drugs and Cosmetics Act, 2023 – the superior legal basis for medical device regulation in Bangladesh：https://objectstorage.ap-dcc-gazipur-1.oraclecloud15.com/n/axvjbnqprylg/b/V2Ministry/o/office-dgda/2024/12/00ced2f8061741aca916c4a670f3c4e0.pdf

Medical Device Registration Guidelines and Risk‑Level Classification Regulations：https://dgda.gov.bd/pages/files/%E0%A6%AE%E0%A7%87%E0%A6%A1%E0%A6%BF%E0%A6%95%E0%A7%87%E0%A6%B2-%E0%A6%A1%E0%A6%BF%E0%A6%AD%E0%A6%BE%E0%A6%87%E0%A6%B8-foev3c-69a7f9dfca59d9089810f996

Risk Classification of Medical Devices and IVD Products

Medical devices registered in Bangladesh are classified into four risk categories: Class A, Class B, Class C, and Class D:

In accordance with relevant regulations and guidelines, IVD products in Bangladesh are classified into four risk categories: Class A, Class B, Class C, and Class D:

Registration Requirements

Medical device registration in Bangladesh has different requirements for products of different risk classes:

① Class A and Class B devices must be accompanied by a Certificate of Free Sale issued by the country of origin and an ISO 13485 Quality Management System certificate.

② Class C and Class D products must be accompanied by a Certificate of Free Sale (FSC) from a recognized country (EU, US, Canada, Japan, Australia) and an ISO 13485 Quality Management System certificate.

Registration Language

English.

License Holders in Bangladesh

Medical device import licenses in Bangladesh will be issued to local companies with the appropriate qualifications that are authorized to represent the manufacturer. No single medical device may have multiple license holders at the same time.

Registration Process, Timeline, and Official Fees

Registration Process

Registration Timeline

The following outlines the registration timeline; the actual duration depends on the complexity of the product.

Official Registration Fees

Chapter 4 FAQ

Q: How long does it take to register a medical device product in Bangladesh?

A: The amount of time taken varies between risk levels. Class A can be approved in 1-2 months, and other risk level products are determined in conjunction with the assessment workload of the authority, which is generally between 6 months and 18 months.

Q: Does it require a QMS certificate for registration of medical devices in Bangladesh?

A: ISO13485 Quality management system certificate is required.

Q: How long is the Bangladeshi Medical Device Registration Certificate valid?

A: 5 years.

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