Medical devices play a major role in modern healthcare. From diagnostic tools to life-saving equipment, they offer better health outcomes. However, these devices must meet safety and quality standards to be effective and trustworthy. And that is why proper registration of these devices is essential.
The only problem is, that navigating the regulatory landscape for medical device registration in Bangladesh can be challenging. Because the process involves understanding complex laws and preparing accurate documentation.
This is where MDR Solution comes in. As a trusted regulatory service provider, our expert team simplifies the process. We ensure compliance with all regulations, saving time and effort for manufacturers and importers alike.
The Need for Registering Medical Devices
Unregistered devices can pose serious health risks, and eventually compromise treatment outcomes. On the other hand, proper registration helps build trust in healthcare services.
Besides, registration facilitates market access and enhances credibility for manufacturers. In Bangladesh, the medical equipment and devices market is growing rapidly. According to BIDA, its market size was valued at $442 million in 2020 and is projected to grow at a 13% CAGR by 2025, valuing approximately $820 million.
This booming market offers immense opportunities for manufacturers. However, only registered products can gain the trust of healthcare providers and consumers.
Moreover, compliance with regulations is mandatory. Failure to register can result in severe legal and financial penalties. Non-compliance may lead to product recalls, fines, or bans, damaging a company’s reputation.
Laws and Regulations for Medical Devices in Bangladesh
In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees the regulation of medical devices. Operating under the Ministry of Health and Family Welfare, the DGDA ensures that medical devices meet safety and quality standards before entering the market.
The regulatory framework is defined by the Drug and Cosmetics Act 2023. It formalizes the requirements for medical and diagnostic devices in the country. This act mandates that all medical devices obtain a Marketing Authorization Certificate to be legally sold in Bangladesh.
Bangladesh has also adopted international standards to align with global best practices. Manufacturers of Class B, C, and D devices are required to provide proof of a certified Quality Management System, typically in the form of an ISO 13485 certificate. This certification demonstrates compliance with international quality standards, indicating that devices are safe and effective for use.
Medical Device Classification, Cost and Validity
International Classifications
In Bangladesh, medical devices are classified based on risk levels, aligning with international standards. The classification system includes four categories:
|
Class |
Risk Level |
Examples |
|
A |
Low Risk |
Tongue depressors, surgical retractors |
|
B |
Low-Moderate Risk |
Suction equipment, hypodermic needles |
|
C |
High-Moderate Risk |
Bone fixation plates, lung ventilators |
|
D |
High Risk |
Implantable defibrillators, heart valves |
Registration Cost
Regarding registration costs, the Directorate General of Drug Administration (DGDA) has specified the following fees:
- Class A: No government fees are required.
- Classes B, C, and D: BDT. 63,250 per product. Registration renewal may cost BDT. 11,500 per product.
Certification Validity
The certifications for Classes B, C, and D are 5 years. After that, they need to be renewed. However, Class-A registered equipment does not require certificate renewal.
Required documents for medical device registration in Bangladesh:
1. Legal agreement (copy) between the manufacturer & the local agent/distributor (and, Letter of authorization).
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 the recall history of past 2 years (duly signed on the letterhead pad of the manufacturer).
6. List of Countries where the product is being marketed. (duly signed on the letterhead pad of the manufacturer).
7. Packaging Materials (empty): Box, Label, IFU, Labeling must reflect the Brand & Manufacturer name, Country of Origin, Mfg. date, Expiry date, Lot no.
8. Colour Catalogue.
9. Annexure-3 (will be prepared by MDR Solution, a prescribed form by DGDA).
Required documents for 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 recall history of past 2 years (duly signed on letter head pad of the manufacturer).
5. Original Packaging Materials: empty Box/Label
6. Original Registration certificate
7. Govt. fees to BDT 11500/product
* Class B, C & Class D registration certificate validity: 5 years
Class A medical device declaration:
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.
Why Hire a Regulatory Service for Registering Medical Devices?
Regulatory service providers simplify this journey, making it faster and hassle-free for businesses. It also means you gain peace of mind, focus on your core business, and avoid the pitfalls of non-compliance. Here is more!
Expertise in Complex Regulations
Understanding the necessary laws governing medical devices can be daunting. However, regulatory service providers have in-depth knowledge of local and international requirements. Their expertise ensures accurate and complete compliance.
Saves Time and Minimizes Errors
Mistakes in documentation or process delays can be costly. A professional service ensures all paperwork is done correctly the first time. This saves valuable time and reduces the risk of rejection.
Faster Approvals and Market Entry
Navigating the approval process efficiently requires skill and connections. Regulatory experts know how to expedite applications, and help manufacturers get their devices to market faster.
Ongoing Compliance Support
Compliance does not end after registration. Regulations often change, and staying updated is critical. However, service providers monitor these updates to make sure your products remain compliant over time.
MDR Solution’s Process for Medical Device Registration
Registering medical devices can be overwhelming, but our MDR Solution team simplifies it with a streamlined, step-by-step process. Here’s how it works:
Step 1: Initial Consultation and Requirement Analysis
We start by understanding your needs. At first, we analyze the device type, classification, and regulatory requirements. This step helps us create a clear roadmap for successful registration.
Step 2: Document Preparation
The next step involves collecting and preparing all necessary documents. These include technical files, ISO certifications (for Class B, C, and D), and proof of quality standards. Our team makes sure every document meets regulatory guidelines, reducing errors.
Step 3: Final Review and Submission
Before submission, MDR Solution conducts a thorough review of the application. We check for completeness and accuracy, ensuring compliance with Bangladesh’s medical device regulations. Once verified, they submit the application to the DGDA.
Step 4: Coordination with Regulatory Authority
After submission, our team manages all communication with the Directorate General of Drug Administration (DGDA). We handle queries, provide additional information if needed, and ensure the process moves smoothly.
Step 5: Post-Registration Services
Our support will not end after you get the approval. We also offer compliance updates, renewal services, and ongoing guidance to ensure your devices remain legally compliant.
How MDR Solution Benefits the Clients
At MDR Solution, we strive to do more than just register medical devices. We provide end-to-end support tailored to your unique needs. Here’s how partnering with us benefits your business:
We Simplify the Registration Process
From the initial consultation to the final approval, we handle every step with precision and care. Our expertise ensures that all requirements are met, paperwork is accurate, and timelines are adhered to. This frees you from the stress of managing the process yourself, allowing you to focus on growing your business.
You Get Customized Solutions
No two businesses are alike, and we recognize this. That’s why we design personalized strategies based on your device type, market goals, and compliance needs. Whether you are a local manufacturer introducing new technology or an international importer expanding into Bangladesh, our tailored approach ensures you meet all regulatory requirements.
Build Long-Term Partnerships
We believe in building trust through consistent support. By staying with you even after registration, we help you adapt to changing regulations and maintain compliance. This fosters a long-term partnership that ensures your business thrives in the healthcare industry.
Enhance Your Brand Credibility
Registered medical devices demonstrate your commitment to safety and quality. Our services ensure that your devices meet the highest standards, and boost your reputation and credibility in a competitive market. This helps you earn the trust of customers, stakeholders, and regulatory bodies alike.
Ensure Business Alignment
Staying aligned with both local and international standards is vital in today’s global market. We ensure your devices comply with certifications such as ISO 13485, which positions your business for success locally and internationally. This alignment strengthens your competitive edge and builds long-term growth opportunities.
Frequently Asked Questions
Q. Is it necessary to register medical devices in Bangladesh?
Ans: Yes, it is mandatory to register medical devices in Bangladesh. The Directorate General of Drug Administration (DGDA) enforces strict regulations to ensure that only safe, effective, and high-quality devices enter the market. Registration is required to comply with the Medical Device Rules 2022 and avoid legal or financial penalties.
Q. How long does the registration process take?
Ans: The timeline for registration depends on the complexity of the device and the completeness of the application. On average, it may take 4-6 months to complete the process.
Q. Can MDR Solution assist with international certifications like ISO?
Ans: Yes, we can. At MDR Solution, we guide clients through the process of obtaining ISO certifications, such as ISO 13485, ensuring alignment with international quality and safety standards.
Q. What happens if a medical device is not registered?
Ans: Unregistered medical devices cannot be legally marketed or sold in Bangladesh. Non-compliance can lead to product confiscation, legal penalties, and damage to the manufacturer’s reputation. That’s why registration ensures smooth market entry and customer trust.
Simplify Medical Device Registration with MDR Solution
Navigating the regulatory process can be challenging. However, with MDR Solution, it can be seamless and stress-free. Because our expert team simplifies every step, ensuring compliance and quicker market access.
So, why face the complexities alone? Let us handle the hard work while you focus on innovation and growth.
Choose MDR Solution for expert regulatory support and long-term success. Reach out today through our website or call us, and make your journey in the medical device industry smooth and rewarding