Last Updated on August 29, 2025 by The Health Master
Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) has teamed up with the Indian Council of Medical Research (ICMR) to create some super important new standards for IVD medical devices.
Think of it as a quality check handbook for all those medical tests.
They’ve just released a draft of these standards of protocol and are asking for feedback from stakeholders.
These new protocols are a game-changer for In-Vitro Diagnostics (IVDs)—that’s the fancy name for all the medical devices that test things like your blood or urine outside the body.
These medical devices are crucial for everything from diagnosing diseases like dengue and malaria to checking on your general health.
The goal of the new standards is simple: make sure these diagnostic tools are top-quality, reliable, and safe for everyone to use.
Why These New Standards are important ?
The Indian government is tightening up the process for getting a license for these medical devices.
Before, the process could be a bit all over the place.
Now, with these new, clear protocols, manufacturers and labs will know exactly what they need to do to prove their products are high-quality.
This means that every time you get a blood test or a swab for a virus, you can have more confidence in the results.
The 180-page document is packed with detailed instructions for evaluating 15 different types of IVDs.
It covers everything from tests for common illnesses like dengue and malaria to more serious ones like the Nipah virus and SARS-CoV-2 (COVID-19).
These guidelines are all about making sure that a device’s sensitivity, accuracy, and safety are properly checked before it gets the green light.
This collaboration between ICMR and CDSCO ensures that the medical devices you rely on are validated and trustworthy.
What are In-Vitro Diagnostics (IVDs)?
In-vitro diagnostics are medical devices that help doctors to know what’s going on inside your body.
They simply take samples like blood, urine, or tissue to figure out the diseases, infections, or specific health issues.
These medical devices are the new inventions in modern medicine, from a simple blood sugar test to a complex genetic analysis.
Under the Medical Device Rules, 2017, a license is required for all IVDs.
These new standard protocols provide a standardized way to evaluate and grant those licenses.
This process ensures that only the best quality and most accurate medical devices make it to go into the market.
The New Protocols:
The new standards of protocol have a clear, step-by-step process for manufacturers and testing labs to follow.
This includes:
Performance Evaluation: A detailed evaluation of how well the medical device works in a controlled setting.
Field Evaluation: Testing the device in real-world conditions to make sure it’s reliable.
These checks are crucial for confirming a device’s clinical and analytical performance.
Think of it as a thorough background check and a job interview all rolled into one for a medical device.
The Call for Feedback
The CDSCO and ICMR have put these draft protocols out for public comment, giving everyone from scientists to manufacturers a chance to weigh in.
They’ve set a deadline of August 25, 2025, for all feedback by the stakeholders.
After finalization, these guidelines will become the new standards of protocols, ensuring a higher level of safety and quality for all diagnostic tests in India.
Q: What are In-Vitro Diagnostics?
A: In-vitro diagnostics are medical devices that help doctors to know what’s going on inside your body. They simply take samples like blood, urine etc. to figure out the diseases, infections, or specific health issues.
Q: Who created these new standards?
A: The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) worked together on these new guidelines.
Q: What’s the deadline for public feedback?
A: Stakeholders can submit their comments on the draft protocols until August 25, 2025.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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