MFDS guidelines STED

  MFDS recently revised its handbook in order to align with STED guidance from International Medical Equipment Standardization


MFDS recently revised its handbook in order to align with STED guidance from International Medical Equipment Standardization Technical Documents.

The revision of MFDS guidelines STED includes more checklists, example and comments to improve the level of clarity.

The Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force (GHTF), a voluntary partnership of government and industry representatives from the United States of America and four other member states: Australia, Canada, the European Union, and Japan. GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format. The proposed harmonized format and content is described in the document titled, “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices,” which represents the proposed STED document. The document was developed by Study Group 1 (SG1) of GHTF and issued as a proposed document on December 16, 2003.

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum.

It is said by MFDS assessors that this revision of the guideline will drastically improve the level of compliance of pre-formatted technical documents.

In addition to this more details were given for a list of 30 products such as: pacemakers, hip joints, balloon catheter etc…

The publication from MFDS can be found here and the guidance can be downloaded from here (guidance document in Korean)



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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.