Choosing an Indian Authorized Agent for Medical Devices: A Guide

by Sudhriti M | May 29, 2024 | Medical Device

Authorized agent for medical devices oversees a foreign manufacturer’s regulatory compliance and import operations in India. This blog will guide you on how to choose an “Indian Authorized Agent” for launching your medical device in India. Who is an Indian authorized...

Plant Master File for Medical Devices Registration

by Sudhriti M | May 28, 2024 | Medical Device, Medical Device License Requirements

Central Drugs Standard Control Organisation (CDSCO) regulates the safety, efficacy, and quality of all medical devices in India. The aim of this regulatory body is to ensure substandard medical devices do not enter the Indian market. To market your medical devices in...

Quality Control in the Medical Device Assembly Process

by Sudhriti M | May 27, 2024 | Medical Device

With advancement in technologies, medical devices have become complicated and intricate with several parts. Manufacturers need to assemble various parts of the medical device to produce a functioning finished product. Hence, medical device assembly quality control...

CDSCO Registration for MRI machine in India

by Sudhriti M | May 21, 2024 | Medical Device

MRI machines play a critical role in enhancing patient care. They help take informed decisions by providing a non-invasive three-dimensional internal view of the human body. In India, awareness regarding the important role ofdiagnostic imaging in early detection is...

BIS Standard for Medical Devices: Everything You Need to Know

by Sudhriti M | May 21, 2024 | Medical Device

India is witnessing a rise in prevalence of chronic, lifestyle, and age-related diseases. The need for advanced and affordable healthcare delivery system and government support are fueling the demand for medical devices. Thus, the Indian healthcare market is thriving....

CDSCO Registration for PPE: Everything You Need to Know

by Sudhriti M | May 21, 2024 | Medical Device

The COVID-19 pandemic highlighted the potential of the Indian medical devices manufacturing sector. During the pandemic, India manufactured and globally distributed medical devices, such as PPE kits, PCR kits, thermometers, and N-95 masks. India’s transformation in...