On September 24, 2012, China’s State Food and Drug Administration (SFDA) issued the final Notice on Further Regulating Labeling and Packaging of Medical Devices Manufactured Overseas (the “Notice”), which will become effective on April 1, 2013.
A draft of this Notice was published for public comment on May 21, 2012, under which SFDA made it clear that packaging and labeling activities are part of the manufacturing activities for medical devices and should be covered by their quality management system (QMS) with effective control; and more importantly, medical devices must bear labels in Chinese when imported into China.
In the final Notice, SFDA uses less explicit language on where the Chinese labels should be put on to the products. While affirming the requirement that imported products must have Chinese labels when being sold and used in China, the Notice merely indicates that foreign manufacturers must establish control procedures in their QMS to ensure compliance with these labeling requirements, including effective documentation and implementation. From a practical perspective, however, this indicates that the labeling site of the products, if not the same as the manufacturing site, would need to be covered by the QMS of the manufacturer and reflected in the relevant certification such as ISO13485.
The Notice provides a grace period until April 1, 2013 for companies to comply with the above requirements. Companies importing device products to China should be prepared accordingly and anticipate inspections and investigations by Customs and SFDA following the effectiveness of the Notice.