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South Korea intends to revise common standard specifications related to biological safety of medical devices
On April 9, 2009, the Korea Food and Drug Administration (KFDA) issued an update to certain common standard specifications aimed at improving the safety of medical devices. This revision was intended to address key concerns related to the use of talc in devices that come into contact with or are inserted into the human body.
The main points of the announcement included:
- Previously, there were no specific standards for talc used in medical devices that interact with the human body. This gap raised concerns about the potential risks associated with its use.
- The new guidelines require that any talc used in such devices must meet the specifications outlined in the Korean Pharmacopoeia, ensuring a higher level of quality control and safety.
- Additionally, the regulations emphasize enhanced monitoring and management of asbestos-like substances, which are known to pose serious health risks if not properly controlled.
This update reflects the KFDA's ongoing commitment to safeguarding public health by maintaining strict oversight of materials used in medical equipment. It also highlights the importance of continuous improvement in regulatory frameworks to keep up with evolving scientific understanding and industry practices.
Shanghai Medical Device Industry Association