
Korean Innovative Medical Device Designation and Evaluation Guidelines
The document provides an overview of the existing legal framework for innovative medical devices intended to be marketed and used in Korea.
The document provides an overview of the existing legal framework for innovative medical devices intended to be marketed and used in Korea.
In the ever-evolving world of medical devices, staying ahead of regulatory changes is crucial for success. Throughout 2024 and into 2025, the global regulatory landscape will continue to transform at an unprecedented pace.
In today’s rapidly evolving regulatory landscape, medical device companies face increasingly complex challenges in managing compliance and bringing their products to market efficiently.
The article provides a general overview of the regulatory approach to be applied with respect to corrective actions.
The new article further elaborates on the most crucial aspects related to corrective and preventative actions to be taken by the parties responsible for medical devices in order to ensure continued safety and proper performance.