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Registration Service of Medical Devices: CRC services Medical Device Business License Medical Device Registration Contract Research Organization ISO 13485 Quality System Certification GMP CE Certification Service FDA Registration (Filing) Software Integrity Verification Service Production process validation service ISO 15378 Medical Package System Certification ISO 13485 Internal Auditors Training Regulatory Services For Medical Devices
Information security service of medical: ISO 27001 Information Security Certification ISO 20000 Information Service Certification Information system grade protection filing Business Continuity Management Services Internal Auditor Training
Medical Software Development: Software of Good Supply Practice(GSP) Production System Development Customized software development

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醫療器械注冊變更根據《醫療器械監督管理條例》（國務院令第650號）的規定，已注冊的第二類、第三類醫療器械，醫療器械注冊證及其附件載明的內容發生變化，申請人應當向原注冊部門申請注冊變更，并按照相關要求提交申報資料。 Time:2018/7/4 15:49:27 View:3753
醫療器械首次注冊流程根據《醫療器械監督管理條例》（國務院令第650號）的規定，對醫療器械按照風險程度實行分類管理。第Ⅰ類是風險程度低，境內生產企業需要在所在地市藥監局進行備案，境外醫療器械生產企業需要委托境內代理人在CFDA進行備案。第Ⅱ類是具有中度風險，境內生產企業需要在所在地省（直轄市）藥監局進行注冊，境外醫療器械生產企業需要委托境內代理人在CFDA進行注冊。第Ⅲ類是具有較高風險，均需要在CFDA進行注冊。 Time:2018/6/29 11:31:24 View:3852

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