- Medical Device Registration 2025

What is the USFDA Classification of an Oxygen Mask?

USFDA classification of an oxygen mask places it under class I medical devices, meaning it has a low risk to users and

CDSCO 2025 Update: Loan License No Longer Required for Medical Device Sterilization

CDSCO loan license for medical devices was once a mandatory approval for companies that didn’t own a manufacturing or sterilization unit. It

CDSCO Clinical Trials for Medical Devices And IVDs (MD-23 & MD-25)

CDSCO clinical trials for medical devices and IVD (form MD 23 & MD 25) are important in India to make sure that

Laboratory Registration MD 40

If you want to test medical devices in India, your lab should be officially registered under form MD 40 with the Central

What is SKD Registration for Medical Device Accessories?

Let’s understand what SKD registration for medical device accessories means and why it’s important in India. If you’re importing or assembling medical

How to Register AI Driven Medical Devices on CDSCO?

Do you know that medical tools and apps using Artificial Intelligence (AI) need approval before they can be used in India? If

How to Register Software as a Medical Device (SAMD)?

Many apps today help with health tracking or medical advice. But if a software is made to diagnose, monitor, or treat a

What are Form MD 5 and Form MD 9?

If you want to manufacture medical devices in India, you need the right licenses from the CDSCO. Forms MD 5 and MD

How to Import Medical Supplies from the USA to India?

If you’re planning to import medical supplies from the USA to India, it’s important to understand the legal steps, license, and documents

CDSCO vs. FDA: Which Medical Device Approval Is Required For India?

If you are planning to enter the Indian healthcare market with your medical device approval, many manufacturers are confused about whether US