medical device labeling

Malaysian Regulators Push Back Medical Device Labeling Requirement Deadline

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA is extending medical device labeling compliance deadlines by three years.
  • The extended transition period is intended to allow Malaysian market registrants enough time to ensure compliance.

New Guidance Clarifies Saudi Labeling Requirements for Medical Devices

The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA).

New Chinese Medical Device Labeling Requirements Set for 2013

The State Food and Drug Administration (SFDA), China’s medical device market regulator, will begin requiring all outside labeling and packaging of devices to be provided in Chinese starting in April 2013.

According to the SFDA and the Regulatory Affairs Professional Society (RAPS), a recent SFDA notice sent to the agency’s provincial and municipal branches in China mandates that all outside labeling and packaging of medical devices include a version in Chinese. Failure to provide labeling and packaging text in Chinese will prevent manufacturers and sponsors from marketing their devices in China.

FDA Seeks Feedback on Device Labeling Requirements

The US Food and Drug Administration (FDA) has requested public comment from health care providers until January 3, 2012 on its proposed