According to the fifth paragraph of Article 69 of China's Patent Law, those who manufacture, use or import patented drugs or patented medical devices for the purpose of providing information needed for administrative examination and approval, and those who manufacture or import patented drugs or patented medical devices exclusively for them, are not regarded as infringement of patent rights. This provision is called "Bolar exception" in China. Therefore, if the imitation activity of an enterprise is to provide information needed for administrative examination and approval, it does not constitute production and operation, and it does not constitute infringement. However, if a patented drug or patented medical device is not manufactured, used or imported for the purpose of providing the information needed for administrative examination and approval, or is specially manufactured or imported for it, it will be regarded as patent infringement.
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software. Medical instruments include medical equipment and medical consumables.