India: Draft Essential Principles for Medical Device Safety and Performance Out for Comment
EMERGO SUMMARY OF KEY POINTS:
- The Indian CDSCO has published draft Essential Principles for medical device and IVD safety and performance.
- Indian regulators are seeking industry comment through August 2017 on the proposed Essential Principles.
- The draft Essential Principles are part of India’s new Medical Device Rules, 2017 slated for early 2018 implementation.
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.
Seven CDSCO Essential Principles
The CDSCO’s seven draft Essential Principles that would be applicable to all devices under the Medical Device Rules, 2017 include:
- A device’s manufacture and design will ensure that it performs as intended without compromising patient or user safety.
- Device design and manufacturing solutions should conform to state-of-the-art safety and risk reduction principles.
- A device’s design, production and packaging should be suitable to its intended purpose under normal conditions of use.
- Safety and performance of a device should not be impacted in terms of compromised patient or user safety due to stresses of normal use.
- Transport and storage conditions should not adversely impact a device’s characteristics or performance.
- A manufacturer should minimize all “known and foreseeable risks, and any undesirable effects” to optimize benefits of using a device under normal conditions.
- A device requires clinical evidence appropriate for its particular intended use and classification to show compliance with essential principles.
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.