Hi,
I have had some guidance translated for medical device change management in South Korea. The document is not very clear in places, so I was hoping to seek some clarification on the following questions;
1. Who is responsible for reporting minor changes? Is it the manufacturer or the local authorised representative?
2. If you need to update the existing license due to a significant change, how long does this take?
3. What information needs to be included in the technical documentation review if the change affects the safety and effectiveness of the device?
Any help/advice would be gratefully received.
I have had some guidance translated for medical device change management in South Korea. The document is not very clear in places, so I was hoping to seek some clarification on the following questions;
1. Who is responsible for reporting minor changes? Is it the manufacturer or the local authorised representative?
2. If you need to update the existing license due to a significant change, how long does this take?
3. What information needs to be included in the technical documentation review if the change affects the safety and effectiveness of the device?
Any help/advice would be gratefully received.