Registration of medical combination package products

Editor of this website :Hangzhou Xinhao Medical Technology Co., Ltd
Release date :2016-06-24 09:18
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For ease of use, a series of medical devices (sometimes including drugs) that handle the same patient in the same condition are often combined together to form a combination& Flash; Medical combination bag , The combination of this device (including drugs) is not a product used in series, that is, it is not a relationship between the whole machine and accessories. Combination medical products include types such as drug packs, medical device (which may include non medical products) combination packs, and drug device combination packs.

医用组合包

Medicine and equipment combination package

The combination package includes both drugs and medical devices. When registering this type of product, the drugs and medical devices need to be registered separately. After obtaining the registration certificate, the product combination package can be sold. The packaged products do not require declaration of combined products and can be sold directly.

Medical device combination package

All products included in the combination package are medical devices. When registering such products, there are generally the following situations:

(1) All individual medical devices in the combination have completed single registration, and the combination packaging only puts them together for sale. This type of product generally does not require further registration and declaration for combination products, and can be sold directly.

(2) If some or all of the combined products have not undergone single registration, they need to be managed according to the medical devices with higher risk levels within the package