CDSCO Manufacturing License for IVDs Class A & B

In-vitro diagnostic devices (IVDs) have a crucial role in patient diagnosis. They are used to understand the current state of health to determine the course of treatment required. Furthermore, IVD devices are used for testing patients in the primary health care facilities where labs are not available. Hence, IVDs have an indispensable role in patient diagnosis and care. Thus, they have to be strictly regulated and monitored. CDSCO has formulated strict guidelines for IVDs in India. This apex regulatory body is aimed at enforcing these regulations to monitor the quality, efficacy, and safety of IVDs. Hence, compliance with Indian IVD regulations is mandatory for all devices entering the Indian market. CDSCO has categorised IVDs into various classes for ease of licensing. Different license types are applicable for different CDSCO IVD classes. We at Pharmadocx Consultants will help you easily secure the CDSCO license for manufacturing Class A and B IVDs.

What are IVDs?

IVDs or in vitro diagnostic devices are basically instruments, reagents, kits, and systems used for diagnosing diseases and health conditions. The term “in-vitro” means in glass. The IVD tests are usually performed in test tubes or other similar equipment outside the body. IVDs are used to collect and examine specimens obtained from the human body. Basically, they are used to understand the current state of health of the patient to determine the course of treatment or next course of action required. IVD tests can be performed using various instruments from small handheld devices to complex laboratory equipment. Moreover, these tests can be performed at the patient’s homes, laboratories, or health care facilities. Owing to the impact of IVDs on the healthcare system, they have to be strictly monitored and regulated.

Need help securing the CDSCO license for IVDs?

Get in touch using the form below

CDSCO IVD Classification System

CDSCO has categorised IVDs into 4 classes to simplify the CDSCO IVD manufacturing license application process. The CDSCO IVD classification system is based on the intended use and risk associated with the device.

1. Class A IVD devices: These are low risk devices.
2. Class B IVD devices: These are moderate risk devices.
3. Class C IVD devices: These are high risk devices.
4. Class D IVD devices: These devices have the highest risk.

What are Class A and B IVDs?

CDSCO class B IVD devices

CDSCO class B IVD devices are moderate risk devices having the following intended use:

• IVD devices intended for self-testing. The devices should be used to obtain preliminary test results that need confirmation using appropriate laboratory tests. These IVD test results should not be used for the final diagnosis of a medically critical status.

Examples: Blood glucose test strips, pregnancy test kits, and urine analysis test strips.

CDSCO License for Manufacturing Class A and B IVDs in India

• Manufacturing license: The CDSCO license for manufacturing Class A and B IVDs is MD 5. The applicant will have to use MD 3 to apply for a license to manufacture, sell, and distribute Class A and B IVD devices in India. The license to manufacture Class A and B IVD devices for sale and distribution in India will be granted under MD 5.
• Loan license: A loan license permits a company without a manufacturing facility to manufacture IVDs. With the loan license, the company can use the manufacturing facility of another company that is manufacturing the same product. The applicant will have to use MD 4 to apply for a loan license for Class A and B IVD devices. The loan license to manufacture Class A and B IVDs without a manufacturing facility will be granted under MD 6.

How to Secure the CDSCO License for Manufacturing Class A and B IVDs? A Step-by-Step Guide

How can Pharmadocx Consultants Help?

Invitro diagnostic devices have a critical role to play in the healthcare industry. They are crucial for diagnosis diseases, providing prognosis, and monitoring progress. Hence, Indian regulations for IVDs are in place to ensure patient safety, protect public health, and improve patient outcome. CDSCO IVD regulations monitor the safety, quality, and efficacy of these devices. Moreover, these regulations ensure manufacturers focus on risk identification and reduction for IVDs. Furthermore, the IVDs should perform as intended for effective healthcare delivery. Notably, the regulations are in place to ensure safe and effective devices reach patients. Hence, having a valid CDSCO license demonstrates commitment to patient safety and delivering high-quality devices. Additionally, it ensures that healthcare professionals are equipped with the best tools for patient care. Therefore, mandatory CDSCO licensing for IVDs is in the best interest of patients and healthcare providers as well as improves brand credibility.

We provide comprehensive services tailored for IVD manufacturers

Avail our CDSCO IVD manufacturing license application service to have a smooth hassle-free regulatory journey. We will leverage our expertise to help you easily secure the CDSCO license for manufacturing Class A and B IVDs. For swift license grant and approval, call/Whatsapp us at 9996859227 or write to us at [email protected].