- 中国医疗行业法律法规中英数据库 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
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.
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