- 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
- （三）包装、标签及标志的检验，如使用木质包装的，须实施检疫； (3) Inspections on packaging, labels and signs, and quarantine if wooden packaging is adopted;
- （三）对不符合进口条件的药品发给进口药品注册证书的； (3) issue a registration certificate of import to a medicine which does not meet the requirements for import; or
- （三）其他不符合药品标准规定的。 (3) It fails in any other way to comply with stipulated drug standards.
- （三）具有能对所生产药品进行质量检验的机构或者人员以及必要的仪器设备。 (3) It must have an organisation or personnel capable of carrying out quality examinations on the drugs produced as well as the necessary instruments and equipment.
- （三）具有与所经营药品相适应的质量管理机构或者人员； (3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.
- （三）具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备； (3) It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.
- （三）具有1名以上经检验检疫机构培训合格的质量管理人员，熟悉相关产品的基本技术、性能和结构，了解我国对进口医疗器械检验监督管理的人员； (3) It shall have more than one quality management staff that have been through training by an IQ organ, are aware of the basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical instruments in China;
- （三）具有2名以上经检验检疫机构培训合格的质量管理人员，熟悉相关产品的基本技术、性能和结构，了解我国对进口医疗器械检验监督管理； (3) It shall have more than two quality management staff that have been through training by an IQ organ, are aware of basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical instruments in China;
- （三）非法组织他人出卖血液的。 (3)illegal organization of other persons in selling blood.
- （四）代理或者经营实施强制性产品认证制的进口医疗器械产品的，应当获得相应的证明文件； (4) It shall have obtained relevant certificate documents, if it engages in the import business of medical instruments under the compulsory product certification system by itself or as an agent;
- （四）代理或者经营实施强制性产品认证制度的进口医疗器械产品的，应当获得相应的证明文件； (4) It shall have obtained the relevant certificate documents, if it engages in the import business of medical instruments under the compulsory product certification system by itself or as an agent;
- （四）具有保证药品质量的规章制度。 (4) It shall have rules and regulations to ensure the quality of medicines.
- （四）具有保证所经营药品质量的规章制度。 (4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.
- （五）机械、电气、电磁兼容等安全方面的检验； (5) Inspections on machinery, electric and electromagnetic compatibility and other aspects of safety;
- （五）代理或者经营的进口医疗器械产品质量信誉良好，2年内未发生由于产品质量责任方面的退货、索赔或者其他事故等； (5) It shall have a good quality reputation when engaging in the business of the imported medical instruments by itself or as an agent, and have no recall, claim for damage or any other accident because of the liability of product quality over the last two years;
- （五）代理或者经营的进口医疗器械产品质量信誉良好，1年内未发生由于产品质量责任方面的退货、索赔或者其他事故等； (5) It shall have a good quality reputation when engaging in the import business of the medical instruments by itself or as an agent, and have no recall, claim for damage or any other accident because of the product quality liability within a year;
- （六）辐射、噪声、生化等卫生方面的检验； (6) Inspections on radiation, noise, biochemistry and other aspects of sanitation;
- （六）连续从事医疗器械进口业务不少于6年，并能提供相应的证明文件； (6) It shall have been engaged in import business of the medical instrument for at least six successive years, and be able to provide relevant certificate documents;
- （六）连续从事医疗器械进口业务不少于3年，并能提供相应的证明文件； (6) It shall have been engaged in the import business of the medical instrument for at least three successive years, and be able to provide relevant certificate documents;
- （七）不按照规定使用麻醉药品、医疗用毒性药品、精神药品和放射性药品的； (7) in violation of provisions, using narcotics, toxic drugs for medical use, psychotropic substances and radioactive drugs;
- （七）有毒有害物质排放、残留以及材料等环保方面的检验； (7) Inspections on emission, residue and materials of toxic and hazardous substances and other aspects of environmental protection;
- （七）近2年每年进口批次不少于10批； (7) It shall have no less than 10 batches of imports for each year in the last two years;
- （七）近2年每年进口批次不少于30批； (7) It shall have no less than 30 batches of imports for each year in the last two years;
- （八）涉及诊断、治疗的医疗器械性能方面的检验； (8) Inspections on performance of medical instruments involving the diagnosis and treatment; and
- （八）收集并保存有关医疗器械的国家标准、行业标准及医疗器械的法规规章及专项规定，建立和保存比较完善的进口医疗器械资料档案，保存期不少于10年； (8) It shall have collected and preserved the national and industrial standards for relevant medical instruments and the regulations and rules and the exclusive provisions concerning medial instruments, and have established and preserved fairly complete data archives regarding the imported medical instruments, with a preservation period of no less than 10 years;
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