In vitro diagnostics (IVD) are medical devices that play a significant role in detecting diseases and monitoring health conditions. Accurate diagnosis depends on the quality and reliability of these devices. And that is why proper registration is essential in Bangladesh.

MDR Solution is a leading regulatory and compliance service provider in Bangladesh. We specialize in navigating complex medical device regulations, including IVD registration. With extensive expertise, our professional team supports businesses by streamlining the registration process and ensuring compliance with local laws.

Overview of In Vitro Diagnostics (IVD)

In Vitro Diagnostics (IVD) refers to medical devices used to test samples like blood, urine, or tissues taken from the human body. These devices provide critical insights into health conditions to enable accurate disease detection, monitoring, and treatment planning.

Examples of IVD devices include:

• Blood glucose monitors for managing diabetes.
• COVID-19 test kits for detecting viral infections.
• Pregnancy test kits for early confirmation.
• Hematology analyzers for assessing blood disorders.

IVDs play an indispensable role in healthcare by delivering precise diagnostic results. They empower medical professionals to make informed decisions and improve patient outcomes. With advancements in technology, IVDs have revolutionized diagnostics, offering faster and more reliable results.

Importance of IVD Registration

●      Ensuring Safety and Efficacy

IVD registration guarantees that devices meet safety standards and perform as intended. This protects patients and healthcare providers.

●      Compliance with Standards

Registration ensures devices align with both national and international regulatory frameworks. It helps minimize legal risks.

●      Building Trust

Registered devices foster confidence among healthcare providers and patients, which ensures widespread adoption.

Classification of IVD Devices

IVD devices are classified based on their risk level and intended use. This helps ensure proper regulatory oversight and safety standards. Globally, classifications often follow a tiered system, such as,

• Class A: Low-risk devices, like laboratory reagents.
• Class B: Low-moderate devices, such as urine test strips.
• Class C: High-moderate devices, including blood glucose monitors.
• Class D: High-risk devices, like HIV or COVID-19 test kits.

In Bangladesh, similar classifications align with global standards, such as those from the World Health Organization (WHO) and the International Medical Device Regulators Forum (IMDRF). The focus is on evaluating potential risks to patients and users.

Importance of IVD Registration in Bangladesh

Registering IVDs is vital for advancing healthcare in Bangladesh. It guarantees safety, compliance, and reliable diagnostics.

Rapid Growth of the Healthcare Industry

Bangladesh’s healthcare sector is expanding rapidly at a surprising rate. This growth demands high-quality diagnostic solutions to meet rising healthcare needs.

Enhanced Diagnostic Capabilities

IVDs play a vital role in strengthening diagnostic systems. Devices like hematology analyzers and PCR kits improve accuracy, and efficiency, and enable faster disease detection. This directly impacts patient outcomes and overall healthcare quality.

Ensures Public Health and Market Access

Regulatory compliance is essential for protecting public health. Properly registered IVDs ensure safety, accuracy, and reliability, reducing risks for patients and providers. Moreover, compliance allows manufacturers to access local and global markets, fostering trust and credibility.

Challenges in In Vitro Diagnostics (IVD) Registration

Navigating IVD registration in Bangladesh can be overwhelming for businesses, as the process demands precision and expertise. Without the right guidance, even small mistakes can lead to significant delays or rejections.

Common Challenges

Here are some of the common challenges businesses face during IVD registration.

●      Complex Regulations and Documentation

The regulatory framework for IVD devices is detailed and complex. Businesses must prepare extensive technical documents, including performance data and risk assessments, which can be time-consuming and challenging.

●      Limited Expertise in Local Regulations

Understanding and complying with Bangladeshi regulatory requirements require specialized knowledge. Many companies lack expertise in local laws, which makes it harder to meet the standards set by regulatory bodies.

●      Delays in Submission and Approvals

The registration process involves multiple steps, from document submission to regulatory review. Without a clear strategy, businesses often face delays, impacting their ability to launch products on time.

●      Consequences of Non-Compliance

Failing to comply with regulatory requirements can result in severe consequences, including fines, product recalls, or loss of market access. Non-compliance also tarnishes the company’s reputation, and it reduces trust among clients and stakeholders.

The Importance of Expert Support

Overcoming these challenges requires a deep understanding of regulatory processes and proactive planning. Partnering with a skilled service provider can simplify the journey, which ultimately saves both time and resources.

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 IVD 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 IVD 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.

How MDR Solution Supports IVD Registration

We bring unparalleled expertise and a client-focused approach to IVD registration in Bangladesh. This is how we make a difference:

Expertise in Regulatory Services

Our team has extensive experience in navigating the complexities of medical device regulations. We specialize in ensuring compliance with local and international standards and help the risk of delays or rejections.

Tailored Support for IVD Registration

We understand that every IVD device has unique requirements. From document preparation to post-approval support, our services are customized to meet your specific needs. This personalized approach ensures efficiency at every step.

Mastery of Local Regulations

With deep knowledge of Bangladesh’s regulatory framework, we excel in handling all documentation and approval processes. Our familiarity with local authorities allows us to address challenges effectively and speed up the registration process.

MDR Solution’s In Vitro Diagnostics (IVD) Registration Process

At MDR Solution, we simplify the IVD registration process by offering a streamlined, and professional approach tailored to your needs. Our team ensures compliance at every stage to help you out.

Initial Consultation and Needs Assessment

We start with a detailed consultation to understand your product, market goals, and regulatory needs. This includes identifying the classification of your IVD device and the required documentation. We also assess any potential challenges and create a customized roadmap for smooth registration.

Document Preparation and Submission

Our team meticulously compiles and reviews all necessary documents, including:

• Technical files and device specifications.
• Clinical and performance data.
• Risk management plans and safety certifications.

We ensure every detail aligns with the standards set by Bangladesh’s Directorate General of Drug Administration (DGDA) and international guidelines like WHO or IMDRF. And once finalized, we submit the documents to ensure accuracy and compliance.

Coordination with Regulatory Authorities

We also serve as a direct link between you and the regulatory authorities to manage all communications. Our team proactively addresses feedback or additional requirements raised during the review process. It keeps timely progress and approval in check.

Post-Approval Support and Updates

MDR Solution provides continuous support, assisting with renewals, compliance updates, or any changes in regulations. We also monitor post-market surveillance requirements to keep your product compliant in the long term.

Partner with Us for Hassle-Free IVD Registration

When it comes to IVD registration MDR Solution is your reliable partner. We simplify the process and ensure full compliance at every step.

Now, are you ready to make your mark in Bangladesh’s growing healthcare market? Let our team guide you with precision and care.

Contact MDR Solution today to start your journey toward seamless IVD registration and impactful healthcare solutions.

Frequently Asked Questions

Q. What types of IVD devices require registration in Bangladesh?

Ans: All IVD devices intended for diagnostics, including blood glucose monitors, pregnancy tests, and hematology analyzers, must be registered. Registration ensures safety, efficacy, and regulatory compliance before entering the market.

Q. How long does the registration process take?

Ans: The timeline can vary depending on the device type and the completeness of the documentation. On average, the process takes 4-6 months, but delays can occur if additional information is requested by the regulatory authorities.

Q. How much does the IVD registration service cost?

Ans: The costs depend on the complexity of the device, the amount of documentation required, and additional support services. You can contact our team for a tailored quote based on your specific needs.

Q. How does MDR Solution ensure compliance with local laws?

Ans: We stay updated on all regulatory changes in Bangladesh and follow international guidelines like those from WHO and IMDRF. Our team meticulously prepares and reviews documentation, coordinates with regulatory authorities and provides ongoing compliance support.