Since the State Council issued the Action Program for Promoting Large-Scale Equipment Renewal and Consumer Goods Replacement in March this year, 28 provinces have issued detailed indicators and specific implementation programs on this large-scale medical equipment renewal and upgrading.
Most of the renewal and upgrading of medical equipment refers to the re-procurement of medical imaging equipment that has exceeded a certain service life, as well as the remodeling and upgrading of some parts and components. However, compared to the replacement of the entire medical imaging equipment, replacing only the bulb tube or parts alone will have certain compliance risks.
Perlove Medical Machine PLX8600
Medical devices are often subject to disputes over whether or not they need to go through a change of registration due to improper replacement of parts, and there is even a risk that the entire machine will be recognized as a medical device that is not registered in accordance with the law. As the whole machine of large medical devices is expensive, once the improper replacement of parts is recognized as not registered in accordance with the law, the use of the unit will be subject to huge penalties.
Take X-ray machine as an example, if you want to modify one of its parts, it depends on whether this part is a key part for the whole machine, such as X-ray bulb tube is a key part. Once an X-ray machine is replaced with a different bulb, it is equivalent to a change in intended use, and therefore a re-registration review is also required, which takes at least 18 months and more.
X-ray machine bulb
If the component does not change the intended use, and does not affect the product for the aging requirements, you need to redo the product performance testing, electrical safety testing, electromagnetic compatibility testing and biocompatibility testing.
In order to prevent the risk of compliance in the process of “renewal and reconstruction” of medical equipment, first of all, we need to follow the requirements of the “Regulations for the Supervision and Administration of Medical Devices”, “Measures for Supervision and Administration of the Quality of Medical Devices”, “Measures for Supervision and Administration of the Business of Medical Devices”, etc., and do a good job in the quality management of the operation and circulation of the use of links. Secondly, medical institutions, medical device business enterprises should do a good job of purchase inspection records, the use and operation of medical devices to comply with mandatory standards and related product technical requirements. Again, medical institutions give priority to the procurement of domestic innovative medical devices, support the use of innovative medical devices on the ground, and build supporting support mechanisms in price declaration, medical insurance access and other aspects.
