【CODEX】医疗器械经营监督管理办法（3-4）-EN
第三章 经营质量管理
Chapter III Administration of Distributing Quality
第三十条 医疗器械经营企业应当按照医疗器械经营质量管理规范要求，建立覆盖质量管理全过程的经营管理制度，并做好相关记录，保证经营条件和经营行为持续符合要求。
Article 30.The medical device distributor shall establish a distributing management system covering all the processes of quality management and make good relevant records according to the requirements of Good Supply Practices for Medical Devices so as to ensure that the distributing conditions and behaviors conform to the requirements constantly.
第三十一条 医疗器械经营企业对其办事机构或者销售人员以本企业名义从事的医疗器械购销行为承担法律责任。医疗器械经营企业销售人员销售医疗器械，应当提供加盖本企业公章的授权书。授权书应当载明授权销售的品种、地域、期限，注明销售人员的身份证号码。
Article 31.The medical device distributor shall take legal responsibility of its office(s) or the selling and buying medical device behaviors of the sales person(s) in its name. The sales person of a medical device distributor shall provide a letter of authorization with an official seal while selling the medical device. The letter of authorization shall clearly indicate the variety, region and time limit of the authorized selling product as well as the ID number of the sales person.
