![<?echo $_SERVER['SERVER_NAME'];?>](/template/twentyseventeen/skin/images/header.jpg)
Recently, some local food and drug regulatory authorities encountered the “Made in xx (country)†label in the original label and packaging label of imported medical device products during the work and the “production site address†in the registration form of the product's medical device registration certificate. The inconsistent state of the marked country. Involving our country's relevant regulatory provisions and international trade rules.
In order to regulate management, the State Food and Drug Administration has recently stipulated clearly the issues related to the management of overseas medical device labels and packaging labels: According to Article 48 of the “Medical Device Registration Administrative Measures†(Bureau No. 16) and “Medical The provisions of Article 5, Article 6, and Article 15 of the “Administrative Rules for Appliances Instructions, Labels, and Packaging Labeling†(Decree No. 10) must be used in Chinese for the textual contents of the instructions, labels, and packaging labels for overseas medical devices. The content of the text shall be in conformity with the relevant contents of the medical device registration certificate and the instruction manual reviewed by the State Food and Drug Administration. In accordance with relevant WTO rules, countries of origin of overseas medical device manufacturers marked in their imported medical device labels and packaging labels in accordance with international trade rules, such as "Made in xx (country)" and other similar expressions, may be associated with Chinese labels and The countries marked on the “Address of Production Site/Production Address†in the packaging label are inconsistent. This does not violate the relevant provisions of Bureau 16 and Bureau 10 orders.
In order to regulate management, the State Food and Drug Administration has recently stipulated clearly the issues related to the management of overseas medical device labels and packaging labels: According to Article 48 of the “Medical Device Registration Administrative Measures†(Bureau No. 16) and “Medical The provisions of Article 5, Article 6, and Article 15 of the “Administrative Rules for Appliances Instructions, Labels, and Packaging Labeling†(Decree No. 10) must be used in Chinese for the textual contents of the instructions, labels, and packaging labels for overseas medical devices. The content of the text shall be in conformity with the relevant contents of the medical device registration certificate and the instruction manual reviewed by the State Food and Drug Administration. In accordance with relevant WTO rules, countries of origin of overseas medical device manufacturers marked in their imported medical device labels and packaging labels in accordance with international trade rules, such as "Made in xx (country)" and other similar expressions, may be associated with Chinese labels and The countries marked on the “Address of Production Site/Production Address†in the packaging label are inconsistent. This does not violate the relevant provisions of Bureau 16 and Bureau 10 orders.