sealing machine is not used as medical device management


Respected client:

Thank you for purchasing the products of Shandong MaYou Medical Service in accordance with Article 28 of the notice on the Classification of products such as Oral Digital observation Instruments (National Food and Drug Administration [2005] 154) and the Classification catalogue of Disinfection products in Annex 3 of document 142 of the Ministry of Health: 

The sealing machines, sealing cutting and printing machines, coiling bag cutting machines, sealing test cards / test bags produced by Shandong MaYou Medical Technology Co.,Ltd. are not products under the jurisdiction of the State Drug Administration and the Ministry of Health. Therefore, there is no need for a medical device registration certificate, a medical device production license or a health permit approval. 

Shandong MaYou Medical Technology Co.,Ltd

January 2018

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