Top 1 Guide to Medical Device Registration in Bangladesh

Introducing medical products into the Bangladesh market takes more than just innovation, it requires regulatory finesse, meticulous information, and local knowledge. With a market expanding at more than 13% per annum with a projected valuation of 200 billion, Bangladesh presents lucrative opportunities for businesses in the medical devices sector. But capitalizing on this opportunity means working within the regulatory environment overseen by the Directorate General of Drug Administration (DGDA).

For new Class B registration or renewal of an existing Class D registration (It is important to familiarize yourself with the drug and cosmetics act 2023 and DGDA requirements. This is where reputable advisors such as Ziva DRA add significant value they simplify approvals, reduce risks, and support global OEMs to achieve full compliance with peace of mind.

So let’s do a quick deep dive into the basic regulations, classifications, registration, and how intelligent support can be crucial in getting your product to market 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.

Medical device market size in Bangladesh:

According to the Bangladesh Investment Development Authority (BIDA), the medical device market is currently valued at $442 million and is expanding at a rate of 13% per year.

The yearly demand for medical devices is estimated to be Tk 200 billion by the Bangladesh Association for Medical Devices & Surgical Instruments Manufacturer and Exporter (BAMDSIME), and it has been expanding at a rate of about 20 percent over the past several years.

Approximately ten companies produce medical equipment and accessories: Getwell, JMI, Techno Drugs, Incepta Pharmaceuticals, Bi-beat, Promixco, and Opso Saline.

In the 1990s, Opso Saline launched local manufacture, which was later joined by JMI and other companies.

Medical device 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.

Medical device classifications in Bangladesh:

Medical devices 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 Medical device 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 Med. 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 Medical device 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 medical devices 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 medical device in Bangladesh.

Ziva DRA is your regulatory consultant for Medical device registration in Bangladesh:

For the registration and compliance of medical devices in Bangladesh, Ziva DRA provides crucial services that have several advantages for producers and distributors.

• Expert Regulatory Guidance: By having a thorough understanding of local laws, Ziva DRA guarantees that all documentation requirements and compliance standards are satisfied quickly, reducing the likelihood of delays and rejections.
• Streamlined Process: By taking care of the registration procedure from start to finish, producers may concentrate on their main business operations and still be in compliance with regulations.
• Compliance Assurance: By guaranteeing compliance with DGDA rules, Ziva DRA lowers the possibility of fines, recalls, or market withdrawal.
• Cost and Time Efficiency : Their experience expedites market entry and helps avert expensive blunders, offering a quicker, more economical route to market.
• Local Market Insights: Ziva DRA provides an insightful understanding of the Bangladeshi market, enabling plans to be more specifically tailored to strategies to meet local demands and enhance product acceptance.
• Local Market Insights: Ziva DRA offers valuable knowledge of the Bangladeshi market, helping tailor strategies to meet local demands and enhance product acceptance.
• Post-Market Support: They provide ongoing compliance support, including renewals and regulatory updates, ensuring products remain compliant.
• Risk Mitigation: Ziva DRA anticipates and mitigates potential regulatory issues, ensuring a smoother market entry process.
• Enhanced Credibility: Utilizing Ziva DRA’s services enhances manufacturer credibility, demonstrating a commitment to regulatory compliance and quality.

In summary, Ziva DRA’s comprehensive services ensure efficient, compliant, and successful medical device registration in Bangladesh, facilitating smoother and more effective market entry.

FAQ

What does the DGDA do and what is its role in respect to medical devices?

The Directorate General of Drug Administration (DGDA) is the regulating authority in Bangladesh for ensuring safety, quality and compliance aspects of medical devices. It handles registrations, import permits, price approval, market control and post-market safety of all devices for medical and health care use.

Are medical devices required to be registered in Bangladesh?

Yes, all medical devices are required to be registered with the DGDA for importation, sales, or distribution in Bangladesh. As a local or global manufacturer, registration helps give you future peace of mind that your product is meeting national health and safety standards.

What is the classification of medical devices in Bangladesh?

The medical devices in Bangladesh are stratified into four risk-based categories as per ASEAN MDD guidelines: Class A – Low risk Class B: Brief to low (or moderate) risk of bias Class C — High to moderate risk Class D – High risk There are different documentation and review requirements for each classification at the time of the registration.

Which documents are needed for registration of a new medical device?

For initial applications, manufacturers are required to provide the following: A licensing contract from the manufacturer to the local distributor Letter of authorization Attested by the embassy. Free Sale Certificates (FSC CE/EC certificates Remember what happened-and what didn’t 2 years ago Sampling, Packaging, Labelling and Color Catalogue Samples of products (generally two pieces of each) Annexure-3 format drafted by Ziva DRA. Note: Par Class c and d devices also need some regulatory certificates of each countries.

For how long is a medical device registration valid in Bangladesh?

Registration of medical devices is for five years. Registration has to be renewed after this period to retain the right for legal marketing and distribution in Bangladesh.

What is required to renew my medical device registration?

For renewal, you need: Updated EC certificate FSCs from the countries of production and its recognized countries (attested by the embassy) New-and-improved package samples and labels Look back on the last two years of history at VOANews.com The original registration certificate Online proof where available Ziva DRA simplifies this work flow to eliminate expirations and regulatory concerns.

Do Government Fees apply for the registration of a medical device?

Yes. Fees schedule of DGDA is now as follows: 63,250/- per product for new registration (Class B, C, D) BDT 11,500 each product for renewing clients Class A medical devices do not require fees. This charge includes the evaluation and processing fees of DGDA for the application.

Is it possible to register Class A medical devices without any government costs?

Yes, Class A, low-risk devices do not need to pay a government fee to register. But, documents and samples for product and approve by DGDA is a prerequisite.

How new Drug and Cosmetics Act, 2023 impacts on the registration of Medical Devices?

Drug and cosmetics act, 2023 now brings in official regulation of medical devices, IVDs and software in its ambit and defines its scope under the law of Bangladesh. It harmonizes local standards to meet international levels and establishes a coherent legal regime for classification, compliance & enforcement.

Why would I use Ziva DRA to register my medical device?

Ziva DRA offers: Expert regulatory guidance Full documentation support Quicker approvals, less delays Continued post-market compliance support Cost and time efficiency Profound insights into the local market for medical devices Ziva DRA offers manufacturers and importers of medical devices professional support, less regulatory hassles and easier entry into the burgeoning healthcare market here.

Conclusion

With the increasing market of Medical devices in Bangladesh, there is great opportunity for global manufacturers and suppliers. But given the fact that there are stringent regulatory clauses and dynamic legal planes like the Drug and Cosmetics Act, 2023, the process is frequently intricate and lengthy.

This is why working with professional consultants, such as Ziva DRA, is not only about filling in your gaps – it is also a competitive edge. From expert file-work through risk management and post-market vigilance, Ziva DRA enables a seamless and effective entry to the medical device market in Bangladesh.

Whether you are registering a new product or re-registering an existing one, Ziva DRA is the partner you can rely on for regulatory success in Bangladesh’s rapidly-growing medical device industry – in confidence, with credibility, and in compliance.

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