In-vitro diagnostic devices (IVDs) are instruments, reagents, or systems used to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes or other similar equipment outside the body. Moreover, the tests can be performed using various instruments from small handheld devices to complex laboratory equipment. Additionally, these tests can be performed at the patient’s homes, laboratories, or health care facilities. Given their role in patient diagnosis, stringent regulations for IVDs are required for patient safety. Hence, the Indian government has rejected IVD clinical trial waiver even if the device has been approved in other countries.

The CDSCO regulates the import, manufacture, and sale of IVDs in India. Moreover, CDSCO regulations for IVDs provide guidelines for IVD manufacturers/importers to ensure their devices are safe and effective. Furthermore, Medical Device Rules, 2017, has laid down the risk-based CDSCO IVD classification system. Different license and application processes will be applicable depending on the CDSCO IVD class type. Compliance with Indian IVD regulations is mandatory to register your devices in India. The CDSCO is aimed at enforcing these regulations to monitor the quality, efficacy, and safety of IVDs in Indian market.

India rejects IVD clinical trial waiver

Owing to the increase in health awareness and demand for minimally invasive diagnostic methods, the demand for IVDs in India is growing. Hence, their quality, efficacy, and safety need to be stringent regulated.

During a recent Drugs Technical Advisory Board (DTAB) meeting, the board decided IVDs would not be eligible for clinical trial waivers. Previously, the government had waived the need for clinical investigations for new drugs offering significant therapeutic benefits that have already been approved in countries, such as the US, UK, Japan, and the EU. However, India’s top advisory body has rejected the provision of IVD clinical trial waiver, even if the device has been approved in other countries.

DTAB has cited the need for country-specific performance assessments, as the reason for opposing IVD clinical trial waiver. It has highlighted that the effectiveness of IVDs could vary owing to genetic factors, biological differences, and environmental conditions that are unique to the Indian population. Hence, the apex board has decided to deny clinical performance evaluation waiver for IVD approval in India.

Notably, in a separate decision, the Indian government has agreed to grant clinical trial waivers for drugs treating rare diseases, new drugs used in pandemic situations, gene and cellular therapy products, and new drugs required for special defence purposes that have already been approved in developed countries. However, the Indian regulatory body has firmly rejected IVD clinical trial waiver even for devices approved in developed countries.

Pharmadocx Consultants: Your trusted regulatory support for IVDs

IVDs have an indispensable role in the healthcare industry. They are vital for diagnosing diseases and providing prognosis as well as monitoring progress. Hence, regulations for invitro diagnostic devices are crucial for patient safety and protection of public health. Thus, CDSCO has laid down stringent regulations for IVDs in India to ensure patient safety and improve patient outcome. A CDSCO license will be required to manufacture/import IVDs in India.

To ensure increased safety and improved outcome of Indian patients, the Indian government has rejected the IVD clinical trial waiver proposal. The CDSCO, the apex regulatory body for IVDs, has formulated stringent regulations for IVDs intended for the Indian market. Securing the CDSCO license is a mandatory requirement for IVD manufacturers/importers. To secure CDSCO IVD license in a hassle-free manner, call/Whatsapp on 9996859227 or drop an email at [email protected]. Our team will provide all-encompassing regulatory support for seamlessly obtaining CDSCO license for IVDs in India. We provide document preparation, mock audit, factory layout designing per regulatory guidelines, and Indian authorised agent service.