Jul 27, 2017
EMERGO SUMMARY OF KEY POINTS:
The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, is seeking input from industry on draft essential safety and performance principles included in new regulations launching in 2018.
Stakeholders have three weeks to comment on the CDSCO’s draft Essential Principles for Safety and Performance of Medical Devices, which make up part of India’s new Medical Devices Rules, 2017. The document includes seven high-level requirements applying to all medical devices and IVD products registered for sale in India.
The CDSCO’s seven draft Essential Principles that would be applicable to all devices under the Medical Device Rules, 2017 include:
Along with the seven major principles for medical devices and IVDs listed above, the draft CDSCO document also addresses issues including chemical, physical and biological properties; infection and contamination risk mitigation; combination products; and medical devices containing biological materials.
Furthermore, the CDSCO has proposed requiring registered manufacturers to maintain documentation demonstrating conformance of their devices to the Essential Principles.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: