Innovative Devices for Clinical Trial Form MD-28 New IVD

Innovative Devices for Clinical Trial Form MD-28 New IVD

The Innovative Devices for Clinical Trial Form MD-28 is an important document for devices that are discovered and newly introduced to the market. The MD-28 Form is essential for registering new in vitro devices (IVD), as it gives permission to import, Manufacture, and market these gadgets.

A diagnostic medical device application can be submitted to the Central Licensing Authority in Form MD-28, either by an authorized agent for imports or by the manufacturer directly. The application should be attached to the fee specified in the Second Schedule and the information outlined in Part IV of the Fourth Schedule. 

What are In-Vitro-Diagnostic (IVD) Devices?

In simple words, in-Vitro Diagnostics, widely known as IVD, Devices are used for testing human bodily fluids, such as Tissue, Blood, Urine, stool, and so on. These types of tests are performed to check for infection, disease, or some primary condition in the human body. The term “in Vitro” means “in the glass.” Indeed, these tests are traditionally performed in test tubes or other glass equipment. 

What is Form MD-28?

The Form MD-28 actually grants permission to manufacture and import new In-Vitro diagnostic medical devices. So, one needs to visit the SUGAM portal and register for innovative devices for clinical trials, such as Form MD-28, a new IVD; this is the only thing anyone can do if one wants to manufacture and import. Although it is a time-consuming process and needs lots of concentration and no mistakes, if you don’t know how to do it, ELT can help you throughout the process. Just visit and get all the solutions from our fantastic team.

Why is Form MD-28 Important?

The Form MD-28 plays a very important role as it allows the Manufacture and Import of any New In-Vitro Medical Devices. 

How is the MD-28 Form Structured?

The Form MD-28 is structured according to capture every essential detail for approving New In Vitro Diagnostics (IVD) Devices. This form is divided into multiple sections to guarantee a detailed review of the device. Here, we have mentioned all the essential aspects you need to know:-

  • Clinical Evaluation Plan 
  • Device Description  
  • Risk Management 
  • Regulatory Compliance 
  • Performed Data 
  • Ethical Consideration

Innovative Devices for Clinical Trial Form MD-28 New IVD Challenges and Considerations 

When dealing with the Innovative Devices Clinical Trial Form MD-28 for new In Vitro Diagnostic (IVD) devices, several challenges and considerations come into play:

Regulatory Compliance – It is Important to Guarantee regulatory compliance. The MD-28 form requires comprehensive documentation and adherence to stringent guidelines illustrated by the Central Licensing Authority. Missing any detail can result in delays or rejection.

Detailed Documentation—The form necessitates extensive documentation, including a clinical evaluation plan, device description, risk management plans, and performed information. Compiling and presenting this information requires meticulous attention and significant time investment.

Ethical Consideration -Ethical considerations must be addressed, particularly concerning the use of human tissues and bodily fluids. Guaranteeing ethical standards are met and reported is an essential part of the application process.

Financial and Time Consideration—The application process for Form MD-28 involves significant financial and time investment. The fees specified in the Second Schedule and the work required to gather the necessary information data can be significant.

Risk Management – Risk management is a vital part of the application. Recognizing, assessing, and mitigating risks associated with the new IVD device is essential for approval. This requires thorough analysis and expert knowledge.


The Innovative Devices Clinical Trial Form MD-28 is a crucial document for the registration and approval of new In Vitro Diagnostic (IVD) devices. It guarantees that necessary regulatory, ethical, and safety standards are met before these devices can be manufactured, imported, and marketed. Although the process is complicated and demands significant effort, it is fundamental for keeping up with the quality and safety of diagnostic medical devices. For those unfamiliar with the process, seeking assistance from experienced professionals can streamline the procedure and enhance the likelihood of successful approval.

What is the purpose of Form MD-28?

The purpose of Form MD-28 is to issue permission to manufacture and import new in-vitro diagnostics (IVD) in medical devices by guaranteeing that they meet safety standards and ethical standards.

Who Can Submit Form MD-28?

Basically, Form MD-28 can be quickly submitted by the agent for import and right away by the manufacturer.

What Kind Of Documentation Is Required For Form Md-28?

Certainly, documentation required for the form MD-28 is a plan of clinical evaluation, a description of the device, a plan of risk management, ethical consideration, and performed data.


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