According to Article 69(5) of China's Patent Law, the manufacture, use, importation of patented drugs or patented medical devices for the purpose of providing information required for administrative approval, as well as the manufacture or importation of patented drugs or patented medical devices exclusively for the purpose of manufacturing or importing patented drugs or patented medical devices are not regarded as infringement of the patent right. This provision has been referred to as the Chinese version of the "Bolar Exception". Therefore, if an enterprise's imitation activity is for the purpose of providing information required for administrative approval, and does not constitute a production or business behavior, it does not constitute infringement. However, if it is not for the purpose of providing the information required for administrative approval, the manufacture, use or import of patented drugs or patented medical devices, as well as the manufacture or import of patented drugs or patented medical devices exclusively for the purpose of such manufacture, use or import of patented drugs or patented medical devices, it is deemed to be an infringement of the patent right.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software. Medical devices include medical equipment and medical supplies.