admin, Author at Blog Insights on Medical Regulatory Services

Post-Approval Changes (PAC) for Medical Devices in India

In India, medical devices are strictly regulated under the Medical Device Rules, 2017, by the Central Drugs Standard Control Organization

The manufacture and import of interventional radiology medical devices are subject to strict scrutiny and compliance with the Indian medical

The cardiovascular medical devices are classified according to the risk class they belong to. The classification is done by CDSCO

It is essential for manufacturers and importers to understand the registration process for anaesthesia medical devices in India. It requires

What is CDSCO? India ranks as one of the largest producers globally of medical devices and in-vitro diagnostic devices, with

It is essential for medical businesses in India to comply with international standards. The Bureau of Indian Standards (BIS) is

Before 2017, a significant part of the Indian medical device market was unregulated. It limited access to safe and high-quality

Medical device manufacturers must have a crystal-clear record of activity. If your medical devices malfunction, the consequences on the lives

The safety and performance of medical devices, once they are marketed to the public, is critical. However, it is not

Medical devices have an undeniable role in healthcare. They help diagnose, treat, monitor, and prevent various complicated conditions. The medical