- Medical Device Registration 2025

What are the Requirements of ISO 13485?

ISO 13485 is an international standard identifying the need for a quality management system (QMS) specifically for the medical device industry. It

What are the ISO Standards for Medical Devices?

ISO standards play an essential role in the medical device industry by ensuring that all the products are safe, reliable, and fulfil

What is Post-Market Surveillance in ISO 13485?

ISO 13485 is the quality management system that maintains the quality of medical devices in India. So, if you are dealing with

Integral CDSCO License for Self-Testing IVDs in India

Navigating the landscape of medical regulation can be haunting, especially for those interested in self-testing IVD diagnostics in India. The interval of

CDSCO License for Anesthesiology Devices in India

When you are a manufacturer, importer or wholesaler of medical devices then you must understand the licensing process. It includes licenses of

What Are CDSCO Form MD-26 And MD-27?

If you are an importer and you want to Import medical devices into India, then both Form MD-26 and MD-27 are important

Difference Between FDA and CDSCO

Are you aware of what is FDA and CDSCO? If not then here we are to explain you difference between FDA and

CDSCO License For ENT Medical Devices

In India, CDSCO (Central Drugs Standards Control Organization) issues the license for the manufacturing, import, sale and distribution of medical devices. The

Definition of Medical Device As Per MDR 2017

Medical Devices are widely used in all branches of medicine, surgery and community not only in India but across the globe. To

CDSCO Medical Device Registration for Pacemaker

Are you an importer or manufacturer of pacemaker medical devices? Then here comes the necessary guide for you. To regulate pacemakers within