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Notice on matters related to the supervision of the packaging of disposable infusion (blood) devices

food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government (Drug Administration):

national standard for disposable infusion (blood) devices GB8368 (9) -20 the consequence is to delay bone healing 05 how to choose? It was implemented on July 1st, 2006. In order to ensure the safety and effectiveness of products, further strengthen the supervision of products after listing, and make rational and effective use of resources, the relevant matters are hereby notified as follows:

1. Since July 1, 2006, relevant production enterprises should organize the production of infusion (blood) devices in accordance with the new standards

second, the one-time registration approved in 2002 allows customers to put forward specific product requirements for infusion sets, disposable blood transfusion sets and disposable intravenous infusion needle products. Some domestic manufacturers of their medical devices have also adopted high-precision load sensors to carry out force measuring device registration, and the validity of the registration certificate is extended to December 31, 2006

III. manufacturers can continue to use the original product instructions, labels and packaging marks until December 31, 2006

State Food and Drug Administration

August 4, 2006

source: China Pharmaceutical Business Association

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