Medical device registration in Korea: appointing medical device quality manager for class 1 products
In case of class 1 medical devices, the voluntary system that allow manufacturers/importers to manage quality control internally was adopted. However, the current medical device act does not require the manufacturers/importers that are seeking licensing to employ the medical device quality control manager, thus posing a limitation to quality and safety management said the MFDS.
The purpose of this change is to define the perimeters of appointing medical device quality manager, preventing problems in the exercise of duty, and requiring the medical device quality manager to comply; in order to minimize risks for the consumer.
The medical device quality manager is in charge of guiding/supervising issues such as quality control, and to regularly receive training on new standard specification and quality control.
The manufacturers/importers are prohibited from interfering with quality control manager’s duty and/or performance. A fine of 3 million Won (approximately $3,000) will be assessed for such violation.
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