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Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment-2026/1/14
2026-01-15查看详情 > -
Document: Medicinal products for human use: monthly figures - January 2026-2026/2/13
2026-02-14查看详情 > -
Document: Cardiac valves - Notified Body 0344 - 07/12/2021 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)-2026/3/24
2026-03-25查看详情 > -
Page: Plasma master file certificates-2026/4/28
2026-04-29查看详情 > -
关于公开征求《新药获益-风险评估技术指导原则》意见的通知-2022/11/8
2022-11-14查看详情 > -
Draft Guidance: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act-2023/4/5
2023-04-06查看详情 > -
Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)-2023/9/29
2023-10-07查看详情 > -
Document: Training module EV-M8 - Considerations on the international transfer of personal (health) data in ICSRs -SUSARs originating in the EU-2025/1/7
2025-01-08查看详情 > -
国家药监局关于批准注册376个医疗器械产品的公告(2025年1月)(2025年第16号)-2025/2/12
2025-02-14查看详情 > -
Document: Pilot on advice from expert panels to manufacturers of high-risk medical devices: Interim report on the experience with the pilot from February 2023 to December 2024-2025/3/24
2025-03-25查看详情 >