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...

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...

CDSCO License Retention Fee: Mandatory for License Validity

by Sudhriti M | Jun 2, 2024 | Medical Device, Medical Device License Requirements

In a recent circular, dated 15.5.24, CDSCO has issued a reminder for license or registration retention under MDR, 2017. This reminder for license and registration certificate renewal requirements is intended for medical device manufacturers, importers, and testing...

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...

CDSCO Anaesthesia Medical Devices Registration in India

by Anmol Singh | Sep 3, 2023 | Medical Device, Medical Device License Requirements

The Central Drugs Standard Control Organization (CDSCO) steers the medical device regulatory ship in India. Anaesthesia devices, vital for surgeries and various medical procedures, are under the spotlight for their important role in healthcare sector. In this blog, we...

CDSCO Oncology Medical Devices Registration and License

by Anmol Singh | Sep 3, 2023 | Medical Device, Medical Device License Requirements

The medical device landscape in India is stringently regulated, with the Central Drugs Standard Control Organization (CDSCO) at the helm. CDSCO ensures that medical devices, especially those as critical as oncology devices, meet stringent standards to guarantee...