A Complete Regulatory Guide by Ziva DRA

Overview

Bangladesh’s healthcare sector is one of the fastest growing in South Asia. Rising incomes, rapid urbanization, and expanding public and private hospital infrastructure have created strong demand for medical devices — from basic surgical instruments and diagnostic consumables to advanced imaging equipment and life-supporting implants.

For any foreign manufacturer or local importer seeking to participate in this growing market, medical device registration with the Directorate General of Drug Administration (DGDA) is a mandatory legal requirement.

At Ziva DRA, we are a dedicated regulatory affairs and compliance service provider specializing in medical device, IVD, pharmaceutical, and cosmetics registration in Bangladesh. We guide our clients through every stage of the DGDA registration process — efficiently, accurately, and with minimal risk of rejection or delay.

Regulatory Authority: DGDA

Medical devices in Bangladesh are regulated by the Directorate General of Drug Administration (DGDA), operating under the Ministry of Health and Family Welfare. DGDA is the sole competent authority responsible for the registration, import authorization, quality oversight, and post-market monitoring of all medical devices in Bangladesh.

The DGDA draws its mandate from the Drugs Act, 1940 and the Drugs (Control) Ordinance, 1982, which have progressively been extended to encompass medical devices. DGDA has also made significant efforts to align its regulatory procedures with WHO guidelines and international best practices.

No medical device — regardless of risk class — may be imported, marketed, or used in clinical settings in Bangladesh without valid DGDA registration.

Classification of Medical Devices in Bangladesh

DGDA classifies medical devices into four risk-based categories. The class of a device determines the level of documentation, scrutiny, and fees required for registration:

Class	Risk Level	Examples
Class A	Low risk	Bandages, Examination gloves, thermometers
Class B	Low to moderate risk	Syringes, infusion sets, surgical gloves, IV Cannula
Class C	Moderate to high risk	Ventilators, Ligating clips, Biosy instrument
Class D	High risk	Cardiac Stent, implantable pacemakers

Class C and Class D devices require a significantly higher volume of documentation, including FSC/CPP from reference countries and EU MDR/CE certification.

Registration Process: Two-Step Pathway

Medical device registration in Bangladesh follows a structured two-step process under DGDA:

Step 1 — Primary Approval (Recipe Approval)

The applicant submits the registration dossier to DGDA. A DGDA committee evaluates the application for completeness and technical compliance. The committee may approve the application for progression or reject it if requirements are unmet. This stage typically takes 3 to 4 months.

Step 2 — Final Registration

Once primary approval is granted, the registration holder submits the full set of required documents for final evaluation. Upon satisfactory review, DGDA issues the registration certificate. This stage typically takes an additional 2 to 3 months.

Total estimated timeline: Approximately 5 to 7 months for products with complete documentation.

Required Documents for Registration (Class B, C & D)

The following documents must be prepared and submitted to DGDA as part of the registration dossier:

1. Legal Agreement (copy) between the manufacturer and the local agent/distributor, along with a Letter of Authorization duly signed by the manufacturer
2. EU MDR Certificate / CE Marking / EC Design Examination Certificate — PDF copy
3. Free Sale Certificate (FSC) issued by the regulatory authority of the manufacturing country — attested by the Bangladesh Embassy in the country of origin (Original required)
4. FSC from a Reference Country — issued by any one of the following: EU country, USA, Germany, Switzerland, Japan, Australia, or UK — attested by the Bangladesh Embassy (Original). Mandatory for Class C and Class D devices
5. Recall History of the past 2 years — duly signed on manufacturer’s official letterhead
6. List of Countries where the product is currently marketed — duly signed on manufacturer’s official letterhead
7. Packaging Materials (empty samples): Box, label, and Instructions for Use (IFU). Labelling must clearly reflect brand name, manufacturer name, country of origin, manufacturing date, expiry date, and lot/batch number
8. Colour Catalogue of the product (2 pieces; physical sample may be required for some products)
9. Annexure-3 — the prescribed DGDA application form, prepared by Ziva DRA on behalf of the applicant

Class A Medical Device: Declaration Prior to Import

Class A (low-risk) medical devices do not require full registration. Instead, a declaration process is followed before importation. The required documents are:

• Agency agreement between the manufacturer and the local agent
• Letter of Authorization from the manufacturer
• FSC of the manufacturing country — attested by the Bangladesh Embassy (Original)
• EU Declaration of Conformity — PDF copy
• Product catalogue
• Product sample — 1 piece (required for uncommon products only)

Government fees: None for Class A device declarations.

Government Fees

Device Category	Fee
Class B, C, D — Initial Registration	BDT 63,250 per product
Class A — Declaration	No fee
Registration Renewal (every 5 years)	USD 137 per product (approx. BDT 11,500)

Registration Validity

A DGDA medical device registration certificate is valid for 5 years from the date of issue. The registration must be renewed before or upon expiry to maintain lawful authorization for continued import and distribution.

Registration Renewal

Renewal must be applied for every 5 years. The following documents are required:

10. Letter of Authorization and Agency Agreement
11. EU MDR Certificate / CE Certificate — PDF copy (online-verifiable preferred)
12. FSC of manufacturing country — attested by Bangladesh Embassy (Original)
13. FSC of reference country (EU, USA, Germany, Switzerland, Japan, Australia, UK) — attested by Bangladesh Embassy (Original). Required for Class C & D
14. Recall history of the past 2 years — signed on manufacturer’s letterhead
15. Original empty box and label
16. Original registration certificate
17. MRP (Price) certificate, if applicable
18. Warehouse/wholesale license copy
19. Government renewal fee: USD 137 per product (approx. BDT 11,500)

Registration Transfer / Local Agent Change

If the registration holder changes or the local agent needs to be updated, the following documents must be submitted to DGDA:

• Letter of Authorization — signed by the manufacturer
• Legal agreement on BDT 300 stamp paper between the current and new registration holder
• Original registration certificates
• No Objection Letter (NOL) from the current registration holder/local agent
• Duplicate certificate issuance fee: BDT 500 + BDT 75 per registration certificate

Post-Registration Obligations

After receiving DGDA registration, registration holders must comply with the following ongoing obligations:

• Distribute only products that conform to the approved labelling, composition, and packaging
• Maintain traceability records for all imported batches
• Report any adverse events, field safety corrective actions, or product recalls to DGDA promptly
• Notify DGDA of any changes to device design, manufacturing site, or local agent
• Apply for renewal well in advance of the 5-year certificate expiry

Why Bangladesh Is an Attractive Market for Medical Devices

Bangladesh presents a compelling opportunity for global medical device manufacturers:

• A population of over 170 million with a rapidly expanding middle class
• Government investment in new public hospitals, district-level health facilities, and specialized medical centers
• A growing network of private diagnostic centers, specialty clinics, and multispecialty hospitals
• Rising demand for surgical instruments, diagnostic kits, imaging systems, and implantable devices
• A medical device market projected to surpass USD 500 million in coming years

Regulatory compliance is non-negotiable. All market participants must complete the DGDA registration process before any device enters the Bangladeshi market.

Frequently Asked Questions

Is DGDA registration mandatory for all medical devices?

Yes. All medical devices — from Class A (low risk) to Class D (high risk) — require either a declaration (Class A) or full registration (Class B, C, D) with DGDA before import or distribution in Bangladesh.

How long does the registration process take?

For Class B, C, and D devices with complete documentation, the total timeline is approximately 5 to 7 months, covering both the primary approval stage (3–4 months) and the final registration stage (2–3 months).

Is CE marking sufficient for registration in Bangladesh?

CE marking is an important part of the documentation, but it is not sufficient on its own. DGDA also requires an FSC from the manufacturing country and, for Class C and D devices, an FSC from a reference country — both attested by the Bangladesh Embassy.

Can a foreign manufacturer register directly without a local agent?

No. An authorized local agent or distributor in Bangladesh is required to hold and maintain the registration. The legal agreement between the manufacturer and the local agent is a mandatory document in the dossier.

What happens if I need to change my local agent after registration?

A registration transfer process must be followed, including submission of a No Objection Letter from the current agent, a new legal agreement, and payment of the relevant administrative fees.

Are clinical trials required for medical device registration?

Clinical trials may be required for certain high-risk (Class D) devices, particularly those that are novel or where safety and performance data is limited. DGDA will specify this during the evaluation process.

How Ziva DRA Can Help

At Ziva DRA, we understand the complexity and nuance of the DGDA registration landscape. Our experienced team provides comprehensive regulatory support including:

• Dossier preparation and gap analysis — reviewing all required documents for completeness and compliance before submission
• Annexure-3 preparation — completing the prescribed DGDA application form accurately on your behalf
• Embassy attestation coordination — guiding clients through the FSC attestation process at the Bangladesh Embassy
• Application submission and tracking — direct submission to DGDA and proactive follow-up at both primary approval and final registration stages
• Device classification advisory — determining the correct risk class for your product under DGDA guidelines
• Post-registration compliance — supporting renewals, agent changes, variation submissions, and ongoing regulatory obligations
• Regulatory intelligence — keeping clients informed of changes to DGDA guidelines, procedures, and fee structures

Whether you are a global manufacturer entering Bangladesh for the first time or an existing importer looking to expand or renew your portfolio, Ziva DRA is your trusted regulatory partner.

Contact Us

Ready to begin your medical device registration in Bangladesh? Contact our team today for a free initial consultation.

Ziva DRA

Regulatory Affairs & Compliance Service Provider

Phone: +88 01915536110

Email: zivadrabd@gmail.com