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South Korea intends to revise common standard specifications related to biological safety of medical devices
April 20, 2009
On April 9, 2009, the Korea Food and Drug Administration (KFDA) announced updates to certain common standard specifications aimed at improving the safety of medical devices. This revision was made to ensure that materials used in medical equipment—especially those that come into contact with or are inserted into the human body—are thoroughly evaluated for safety.
One key focus of the update was on talc, a substance commonly used in the manufacturing of medical devices. Prior to this revision, there were no specific standards in place for talc used in such applications. As a result, the KFDA introduced new guidelines requiring that any talc used in medical devices must meet the specifications outlined in the Korean Pharmacopoeia. This ensures that the material is safe and suitable for its intended use.
Additionally, the updated regulations emphasized stricter controls over asbestos-like substances, which can pose serious health risks if not properly managed. These enhanced requirements aim to improve overall public health protection by minimizing exposure to potentially harmful materials.
The changes reflect a growing emphasis on quality control and patient safety within the medical device industry. Organizations like the Shanghai Medical Device Industry Association have been closely monitoring these developments, as they directly impact the production and regulation of medical equipment in both domestic and international markets.
This update serves as a reminder of the importance of continuous improvement in regulatory frameworks to keep pace with advancements in medical technology and evolving safety concerns.