Author: ELT Team

Procedure to Obtain Manufacturing License for IVD

Are you the one who is willing to manufacture IVD medical devices in India then you must undergo the procedure to obtain

Registration Of IVD In India

The Central Drugs Standard Control Organization (CDSCO) oversees the registration of IVD in India. The number of IVD devices requiring complete technical

What is Voluntary Registration in CDSCO?

In India, Medical Devices are regulated by the Central Drugs Standard Control Organization (CDSCO). Only the Notified Medical Devices have been regulated

Importance Of Medical Device Compliance In India

Those dealing with medical devices must understand the importance of medical device compliance in India. This will ensure the medical device’s safety

Retention of Import License in India

CDSCO has issued essential guidance on retention of import license in India. This process is coming into effect under the new rules,

What Is EPR Annual Compliance?

This is your go-to guide if you want to understand Extended Producer Responsibility (EPR) in detail. EPR Annual Compliance refers to the

What is Quality System Regulation (QSR)?

The Quality System Regulation, in short, QSR, is a set of standards and rules introduced by the authorities to ensure that medical

Procedure to Apply for InVitro Diagnostic Import License

The Procedure to apply for InVitro Diagnostic import license is followed. Initially, evaluation of the product is to be done to ascertain

Documents Required For Medical Device Registration

If you are willing to apply for an MD License in India then you must understand first which license you require. After

How Can I Apply For Class A Medical Device Registration?

If you are dealing with a Class A medical device, then you must apply for Class A Medical Device Registration in India.