21 CFR 801 翻译稿中英文对照.pdf

801.1 Medical devices; name and place of business of manufacturer, packer or distributor. 医疗器械，制造商、包装商或分销商的经营名称和地址 (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. 器械包装的标标识上应醒目地标明制造商、包装商或分销商的经营名称和地址。 (b) (b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for Company, Incorporated, etc., may be used and The may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. 对于制造商、包装商或分销商的名称，要提供公司的真实名称，在公司名称的前 后可列出该公司特定部门的名称。公司名称可以使用Company,Incorporated 等的缩写，其中的The可以省略。对于个体企业、合伙企业、或社团法人来说， 应当给出开展经营活动时使用的名称。 (c) (c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, Manufactured for ___, Distributed by _____, or any other wording that expresses the facts. 如果包装标识的单位名称不是制造单位，则应当对此名称加以限制，以表明与此 标识上的单位与该产品的关系，可使用Manufactured for ___,或 Distributed by _____说明。 (d) (d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revi