Jun 26, 2019

The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association, has partnered with global regulatory consulting firm Emergo by UL to provide European market compliance support to the group’s more than 500 member companies.

In a new Memorandum of Understanding (MOU) between KMDICA and Emergo by UL, KMDICA members will have access to the consultancy’s following services at discounted rates:

  • European Authorized Representation service for medical device manufacturers with no physical presence in Europe;
  • Free access to Emergo by UL’s RAMS Track software as a service (SaaS) for digitized management of medical device registrations in multiple markets;
  • European Medical Devices Regulation (MDR) transition consulting and gap analysis ahead of the Regulation’s coming into full effect in 2020.

In addition, Emergo by UL will assign a dedicated project coordinator based in South Korea to support KMDICA member companies that take advantage of the consulting and in-country representation services covered in the MOU. KMDICA will utilize Emergo by UL as its preferred RA/QA consulting partner for European MDR compliance.

“As South Korea’s medical device industry becomes increasingly export-oriented and state-of-the-art, KMDICA recognizes that its members can more efficiently meet MDR requirements and enter the European market with experienced QA/RA support,” says Michael van der Woude, Director and General Manager of Market Access at Emergo by UL. “We are excited that KMDICA has chosen Emergo by UL as a partner to assist South Korean medical device companies with European market access.”

About KMDICA

Established in 1979, Korea Medical Devices Industrial Cooperative Association (KMDICA) has more than 500 medical device company members in South Korea. KMDICA promotes and advocates for the South Korean medical device industry, providing education, training and research support to member firms. Learn more about KMDICA.

About Emergo by UL

Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow at EmergobyUL.

Author

  • Stewart Eisenhart

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