The Bureau of Indian standards (BSI) has published a new standard IS 23485 medical Devices -quality Management system requirements and essential principles of safety & performance for medical devices (IS).

The new standard has been formulated by amalgamation of the following existing standards.

ISO 13485: 2016 Medical Devices - Quality Management Systems – Requirements for Regulatory Purposes.

16142-1:2016 Medical Devices - Quality Management Systems – Requirements for Regulatory Purposes.

16142-2:2017 – Medical Devices – Recognized essential principles of safety and performance of medical devices – part 2 General essential principles and additional specific essential principle for all IVD medical devices and guidance on the selection of standards.

BIS has informed that organizations on implementing the new IS, would become complaint 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.

Our expert team will guide Domestic manufacturers and foreign manufacturers in terms of documentation, testing of devices and final certification. The foreign manufacturers will have to take the roue of Foreign Manufacturer’s Certification Scheme (FMCS)