In vitro diagnostic (IVDs) registration in Bangladesh

Regulatory authority:

The Director General of Drug Administration (DGDA) is the primary regulatory authority in Bangladesh for Pharmaceuticals, Medical device, IVDs, Medicated cosmetics, and Food supplements in Bangladesh. DGDA ensures the regulation of local manufacturing, distribution, import & export of those products to ensure the compliance of products.

The responsibilities of DGDA in Medical device industries are-

1. Register medical devices
2. Giving import permit (Indent approval)
3. Clearance from indent approval
4. MRP approval
5. Pharmacovigilance monitoring
6. Market visit to ensure product quality.

IVDs market size in Bangladesh:

According to the Statista, Bangladesh’s in vitro diagnostics market is expected to generate US$51.32 million in sales by 2024. The revenue is expected to grow at a compound annual growth rate (CAGR) of 5.95% from 2024 to 2029, reaching a market volume of US$68.50 million by that time. Bangladesh imports fully outside of the country. Majority are imported from Chinese and Indian manufacturer.

IVDs law in Bangladesh:

The Drug and Cosmetics Act, 2023, published by the Bangladeshi government, went into effect on September 18, 2023. It formalized standards for IVD reagents, medical devices, and included software to the definition of medical devices, which is categorized under drugs in the rules.

Definition of Medical device in the Drugs and Cosmetics Act, 2023:

“medical device” includes-

(a) all devices including an instrument, apparatus, implement, machine, appliance, implant, diagnostic reagent (in vitro, in vivo and in silico reagent), software or similar/related material or other article, whether used alone or in combination, to be used specially for human beings or animals by such means for one or more of the specific purposes of:

(i) diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder;

(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;

(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;

(iv) supporting or sustaining life;

(v) control of conception or disinfection of medical devices;

(vi) To provide information through examination and analysis of samples collected from human or animal body whose desired action is not affected by pharmacological, immunological, and metabolic action.

(b) Any device and diagnostic reagent declared by the Government, by notification in the Official Gazette, for the purpose of carrying out the purposes of this Act.

IVDs classifications in Bangladesh:

IVDs are closely aligned with the ASEAN MDD and are categorized into four groups, A, B, C, and D, based on their level of risk.

Import base IVDs registration required documents:

1. Legal agreement (copy) between the manufacturer & the local agent/distributor (and, Letter of authorisation).
2. EC Certificate/CE marking/EC Design examination Certificate.
3. FSC (Free Sale Certificate) of Manufacturing country -Bangladesh Embassy attested. Original
4. FSC of any EU country/USA/Germany/Switzerland/Japan/Australia/UK-Bangladesh Embassy attested (This is required for Class-C & Class-D IVD device).
5. Details regarding recall history of past 2 years (duly signed on letter head pad of the manufacturer).
6. List of Countries where the product is being marketed. (duly signed on letter head pad of the manufacturer).
7. Packaging Materials (empty): Box, Label, IFU, Labelling must reflect the Brand & Manufacturer name, Country of Origin, Mfg. date, Expiry date, Lot no.
8. Two (2) pc sample/Colour Catalogue.
9. Annexure-3 (will be prepared by Ziva DRA, a prescribed form by DGDA).

Mentioned documents are required for first time registration only. Each registration validity 5 years. After 5 years, local distributor need to renewal again.

Required documents for Import base IVDs registration RENEWAL:

1. EC Certificate-pdf copy (Online verifiable).
2. FSC (Free Sale Certificate) of Manufacturing country -Bangladesh Embassy attested. Original
3. FSC of any EU country/USA/Germany/Switzerland/Japan/Australia/UK-Bangladesh Embassy attested (This is required for Class-C & Class-D Med. device).
4. Details regarding the recall history of the past 2 years (duly signed on the letterhead pad of the manufacturer).
5. Original Packaging Materials: empty Box/Label
6. Original Registration certificate

Class A medical device declaration/registration:

1. Agency agreement between the manufacturer & the local agent.
2. FSC (Free Sale Certificate) of Manufacturing country -Bangladesh Embassy attested. Original
3. Product catalogue.
4. Product sample-2pc.
5. No Govt. fees required.

The government fee for registering IVDs in Bangladesh:

1. New registration: BDT 63250/product for new registration which involved two application process for Class B, C & D. government fee is not required for A class products.
2. Registration renewal: BDT 11500/product for renewal B, C & D class IVDs in Bangladesh.

Ziva DRA is your regulatory consultant for IVDs registration in Bangladesh:

In vitro diagnostic (IVD) medical devices are a dynamic field characterized by quick developments and strict regulations. It’s critical for businesses hoping to enter the Bangladeshi market to navigate the intricacies of IVD registration. In order to guarantee a smooth and legal entrance into the Bangladeshi market, Ziva DRA steps in as a reliable partner in this situation.

Who We Are
Our goal at Ziva DRA is to offer complete regulatory services for the in vitro diagnostic (IVD) device registration process in Bangladesh. Our staff is made up of seasoned experts with a wealth of regulatory affairs knowledge, so we can guarantee that our clients get the most precise, current, and useful advice for their IVD products.

Our Objective
Our goal is to make it easier for IVD manufacturers to obtain regulatory approval so they can confidently and effectively introduce cutting-edge, life-saving diagnostic technologies to the Bangladeshi market. Our goal is to minimize our clients’ expenses and time-to-market while maintaining the highest standards of regulatory compliance.

Understanding the Regulatory Landscape
The principal regulatory agency in Bangladesh in charge of approving and registering IVDs is the Directorate General of Drug Administration (DGDA). Before IVDs can be sold, the DGDA requires thorough evaluation procedures to guarantee that they meet strict safety, effectiveness, and quality standards. It takes extensive knowledge and a close grasp of both national and international regulatory frameworks to navigate these restrictions.

Our Services

1. Regulatory Consultation and Strategy Development
2. Document Preparation and Submission
3. Liaison with Regulatory Authorities
4. Compliance and Quality Assurance
5. Post-Market Surveillance and Support
6. Approved registration from DGDA
7. Import permit
8. MRP approval

Why choose Ziva DRA?

Expertise: Our team ensures that our clients receive the best level of expertise by bringing in-depth understanding of both domestic and international regulatory environments.
Tailored Solutions: We recognize the individuality of every IVD product. Our solutions are tailored to each client’s unique requirements, guaranteeing the best possible regulatory results.
Efficiency: By reducing time-to-market with our proactive strategy and optimized processes, we help clients meet their business goals more quickly.
Dedication: Our success is our first priority. Our dedication to quality motivates us to go above and above in providing outstanding regulatory services.

Ziva DRA is comprehensive regulatory service provider for IVDs registration. With our expertise, dedication, and comprehensive service offerings, we empower manufacturers to navigate the regulatory landscape with ease, bringing innovative diagnostic solutions to market swiftly and compliantly.

For more information on how Ziva DRA can assist with your IVD registration needs in Bangladesh, please contact us today.

Contact us at islam_saiful@hotmail.com or polash@zivadra.com