CDSCO Operation Theatre Medical Device License Application

by Sudhriti M | Nov 22, 2024 | Medical Device, Medical Device License Requirements

Operation theatre medical devices have a crucial role in facilitating surgeries and ensuring positive patient outcome. In addition to specialized equipment, basic general operation theatre medical devices, such as surgical table, have equally important roles....

CDSCO MD 15 License for Importing Medical Devices into India

by Sudhriti M | Nov 6, 2024 | Medical Device, Medical Device License Requirements

India has a rapidly growing domestic medical device manufacturing industry. However, India still heavily relies on medical device imports to fulfil the requirements of the healthcare system. To import medical devices into India, importers have to mandatorily obtain a...

Materials Used for Manufacturing Medical Devices: A Guide

by Sudhriti M | Oct 30, 2024 | Medical Device

When manufacturing medical devices, safety, regulatory compliance, performance, and resilience are the major factors to focus on. Furthermore, while choosing medical device manufacturing materials, biocompatibility, durability, and regulatory compliance are some of...

How to Identify a Predicate Device? A Detailed Guide

by Sudhriti M | Oct 30, 2024 | Medical Device, Medical Device License Requirements

Planning to market your medical device in the US? Then, you will have to secure the US FDA 510(k) approval. For which you will require proper documentation and have to select the appropriate predicate device. You will need the predicate device to prove substantial...

US FDA 510(k) Dossier Preparation: Everything You Need to Know

by Sudhriti M | Oct 30, 2024 | Medical Device

510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) for Class I, II, and III medical devices. This premarket submission is used to demonstrate evidence of substantial equivalence. The process is...