中国医疗行业法律法规中英数据库
（一）书面申请书，并有授权人签字和单位盖章； (1) An application in written form with a signature of the authorized person and the official seal thereon;（一）未标明有效期或者更改有效期的； (1) An expiry date is not indicated or is altered; or（一）植入人体的医疗器械； (1) Any medical instrument implanted into the human body;（一）介入人体的无源医疗器械； (1) Any unpowered medical instrument intervening in the human body;（一）具有高等学校医学专业本科以上学历，在执业医师指导下，在医疗、预防、保健机构中试用期满一年的； (1) Anyone who has received at least regular medical college education in an institution of higher learning, and has, under the supervision of a medical practitioner, served at least one year on probation in an institution of medical treatment, prevention or health care; or（一）符合本条例第六条规定的品种或者已经解除一级保护的品种；? (1) are conforming with the stipulations set forth in Article 6, and are removed from Grade 1 protection;（一）对特定疾病有特殊疗效的；? (1) are with special therapeutic results to a given disease;（一）一类进口单位进口的，年批次现场检验率不低于10%； (1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 10 percent;（一）一类进口单位进口的，年批次现场检验率不低于30%； (1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 30 percent;（一）一类进口单位进口的，实施现场检验与监督检验相结合的方式，其中年批次现场检验率不低于50%； (1) As for the import by a Category A importer, the spot inspection shall be performed combining with surveillant inspection, and the annual rate of spot inspection of batches shall not be lower than 50 percent; and（二）以非药品冒充药品或以他种药品冒充此种药品的。 (2) A non-medical substance is passed off as a medicine, or one medicine is passed off as another.（二）不注明或者更改生产批号的； (2) A registration number is not indicated or is altered; or（二）以非药品冒充药品或者以他种药品冒充此种药品 (2) A substance that is not a drug is passed off as a drug, or one sort of drug is passed off as another drug.（二）调整缺陷进口医疗器械进口单位的分类管理的类别； (2) adjusting the category of the importer of the defective medical instruments in the classified management;（二）存在安全卫生缺陷或者可能造成健康隐患、环境污染的； (2) any defectiveness in safety and sanitation or any possible potential health risks or environmental pollution; or（二）不属于高风险的其他与人体接触的有源医疗器械； (2) Any other powered medical instrument contacting the human body but not at the level of high risk; and（二）介入人体的有源医疗器械； (2) Any powered medical instrument intervening in the human body;（二）相当于国家一级保护野生药材物种的人工制成品；? (2) are prepared with natural medicinal herbs covered by Grade 1 protection by the state; and（二）对特定疾病有显著疗效的；? (2) are with noticeable therapeutic results to a given disease; and（二）二类进口单位进口的，年批次现场检验率不低于30%； (2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 30 percent; and（二）二类进口单位进口的，年批次现场检验率不低于50%； (2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 50 percent; and（二）二、三类进口单位进口的，实施批批现场检验。 (2) As for the import by a Category B or C importer, the spot inspection of each batch shall be performed.（三）用于支持、维持生命的医疗器械； (3) Any medial instrument used for the life support or life maintenance;（三）产品质量较不稳定，多次发生质量问题，对其安全性有效性必须严格控制的医疗器械。 (3) Any medical instrument that are unstable in product quality, have led to quality problems for several times, and must be controlled rigidly in product safety and effectiveness.（三）可能危害医患者生命财产安全，情况紧急的。 (3) any possible circumstance that may harm the life or property safety of the doctor or patient or any emergency.
