India: Consultation on Essential Principles for Medical Devices

The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has released draft guidance on the safety and performance of medical devices. The document provide binding guidance for use in the manufacturing of medical devices which are intended to be sold in India.

This guidance document describes fundamental design and manufacturing requirements, referred to as „Essential Principles for Safety and Performance‟ that, when met, indicate a medical device is safe and performs to its specification. The regulator has selected seven essential principles that apply to all types of medical device and a longer list of requirements that only apply to certain classes of product.

For the document please go here.