Explanation on Medical Sealing Machines Not Being Used as Medical Devices

  In the medical sterilization packaging process, the medical sealing machine is a common equipment widely used in the final packaging process of sterile items such as surgical instrument packages and dressing packages. However, there have long been different understandings within the industry regarding whether it belongs to medical devices. Many people mistakenly believe that sealing devices used in medical environments should be included in medical device management, but this is not the case. Below are some materials for everyone to learn about together. 

  Food and Drug Administration (FDA) of each province, autonomous region, and municipality directly under the central government: 

  To meet the needs of supervision and management of medical devices in various regions, the classification and definition of 42 products, including oral digital observation devices, are hereby notified as follows: 

  Twenty-eighth、 Sterilization bag sealing machine: used to seal sterilization packaging bags. Not managed as a medical device. 

  The products defined as medical devices mentioned above will be classified according to the adjusted categories starting from November 1, 2005. From the date of publication, the relevant food and drug regulatory authorities may accept registration applications for such products. 

  Data source: National Food and Drug Administration, April 15, 2005, Notice on Classification and Definition of Oral Digital Observation Devices and Other Products (State Food and Drug Administration [2005] No. 154). 

  The above is the relevant information compiled for everyone. Through learning, we can have a clearer understanding of the categories of medical sealing machines.