Medical Device 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.

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.

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