BSI Korea and The Korean Testing Laboratory hold joint medical device EU regulatory update

Enews - 13 October 2015

Monday October 5th Seoul Korea

Korea and BSIBSI Korea and The Korean Testing Laboratory (KTL) jointly held a successful European Union (EU) medical device regulatory update conference.

The event, hosted by KTL at their central Seoul facility, attracted more than fifty senior Medical Device Regulators, representing a broad range of Korean manufacturers.

The agenda covered recently enacted changes to the existing Medical Device Directives, including unannounced audits and increased scrutiny of notified bodies. The conference also detailed the significant changes to the three Medical Device Directives, currently in negotiation in Europe, highlighting an expected publication date of the middle of 2016. Key topics and speakers included:

  • Gary Slack, Senior Vice President Global Medical Devices BSI Group Recently enacted changes to the EU Medical Device Directives and the Proposed 2016 EU Medical Device regulation.
  • Xiangdan Kim, General Manager LEPU Consultation Comparison of the Chinese /EU and Korean Regulatory System for Medical Devices.
  • Dr Liang Qian, Asia Pacific Lead BSI Group The New ISO 13485: 2016 Revision.

LEPU Consultation is a subsidiary of the major Chinese medical device manufacturer LEPU Medical Group.

The extremely well received event generated strong delegate engagement and participation, underlining the Korean manufacturer’s strong desire to better understand the EU regulatory landscape and meet current and future requirements.

The event demonstrates BSI and KTL’s increasing commitment to the medical device sector in the Korean Peninsula, which is demonstrating significant innovation and robust growth.

Gary Slack

Senior Vice President Global Medical Devices, BSI Group.




Notes to Editors:

Korean Testing Laboratory

Korean Testing Laboratory (KTL) is a leading testing and certification body in Korea established for the purpose of improving industrial technology and global competitiveness. KTL has been providing support for the development of testing and evaluation technologies and has been helping companies obtain domestic and international certifications for more than fifty years.

About BSI

BSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world’s first National Standards Body and a founding member of the International Organization for Standardization (ISO). Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, manage risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Renowned for its marks of excellence including the consumer recognized BSI Kitemark™, BSI’s influence spans multiple domains including Aerospace, Automotive, Built Environment, Food, Healthcare and IT. With over 80,000 clients in 172 countries, BSI is an organization whose standards inspire excellence across the globe.

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