The Bureau of Indian Standards (“BIS”) has published a new standard IS 23485 Medical Devices – Quality Management System requirements and Essential Principles of safety & performance for Medical Devices (“IS”) on its website.
The new standard has been formulated by amalgamation of the following existing Indian standards:
- ISO 13485 : 2016 – Medical devices – Quality management systems – Requirements for regulatory purposes;
- 16142-1 : 2016 – Medical Devices – Recognized essential principles of safety and performance of medical devices – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards; and
- 16142-2 : 2017 – Medical Devices – Recognized essential principles of safety and performance of medical devices – Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BIS has informed that organizations, on implementing the new IS, would become compliant with the essential principles of safety and performance as well as the quality management system requirements of medical devices, including
- risk evaluation and management for the designing and manufacturing of medical devices,
- clinical evaluation,
- bio compatibility verification,
- environmental effects’ assessment,
- software validation and
- other safety and performance related aspects likely to be encountered during entire life cycle of a medical device.
Source: Bureau of Indian Standards