Suture

Guideline for polypropylene suture

This guideline for polypropylene suture was prepared to help the writing of the technical documentation and subsequent approval.

This guideline for polypropylene suture was prepared to help the writing of the technical documentation and subsequent approval.

Polypropylene suture is a non-absorbable type of suture used for approximating and ligating soft tissue.

Main content of this guideline includes:

  1. medical equipment approval authorization process
  2. approval and technical requirement items, and
  3. examples of technical requirements.

MFDS Evaluation stated that through this publication of guideline, they hope to increase the understanding of how to write approval/technical writing and increase the speed for the approval process.

The link to the original publication can be found here on the MFDS website (in Korean).

 

About nicolas

My name is Nicolas Clary, I'm the founder and CEO of Kobridge Consulting Ltd. in 2006 when I met my wife in Korea I had no idea it would lead me to this. At that time I was already a consultant and regulatory expert for Medtech companies. I was also an auditor for the French Notified Body LNE. In 2007 I decided to move to Korea to establish a consulting business there. At first I was like most my actual clients : completely lost. It took me a lot of time to understand all the regulatory processes in Korea and fortunately I was lucky enough to find the right people. I am much better now at understanding my clients' needs because I've been in their shoes before. I usually say that I'm a translator. Understanding different regulations helps to explain certain requirements (here Korea vs Europe or US). I can also translate the needs of regulatory professionals to sales professionals and vice versa.