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We present our insights from the past quarter. Advances in regulatory harmonization, as shared after the first three months and second three months of the year, continue. While it may have been a summer break for many, regulatory developments abound. This update features regulatory harmonization and a number of global developments revolving around Unique Device Identifiers (UDI). Word of the day..

Emergo by UL presented some of the elements to consider as part of the regulatory strategy: market and sales potential, reimbursement possibilities, academic and physician interest, and the regulatory system, including global harmonization or reliance. We use the example of South Korea where because of the public healthcare system (95% universal public healthcare system, 1989 National Health Ins..

While it was a whirlwind of less than 25 minutes for five lofty learning objectives on global regulatory strategy, we felt all the topics were seminal. A synopsis of one part of our presentation follows. The importance of a well-defined intended purpose and indications for useAs we continue to observe issues related to the intended purpose/use and indications for use, we emphasized the importanc..

Historically, the U.S. has been the leader in medical product human factors (HF) engineering maturity with stringent regulatory enforcement, followed by the European Union (EU) with less stringent regulatory enforcement, while most other global regions have had little or no HF guidance or enforcement. However, in the past few years, the global regulatory landscape has continually evolved as othe..

Global harmonization continues to excite us all. And, global harmonization of medical device registration submissions is one way to advance the objectives of the International Medical Device Regulators Forum (IMDRF) and regulatory reliance. These documents are a must-read for any serious regulatory professional. Here we elaborate on our regulatory update featured in April 2023.  Background on IM..

This is the first in our series on the UK MHRA initial draft recognition policy to leverage international regulatory authorizations for access to the medical device market. The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted a webinar in March on the update of the draft medical devices scope, classification and essential requirements. This was a..