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最新公告 Bulletin Board
Medical Device Regulatory Updates

Medical Device Regulatory Updates

PUBLISHED MDCG GUIDELINES

  • There are several guideline documents published by MDCG which has impact on the industry. Please follow this link and perform impact assessment on your organisation.

COVID-19

  • List of COVID-19 essential Medical Devices (MDs and IVDs) available from now. Please follow this link to find out the details.
  • European standards for medical supplies made freely available to facilitate increase of production. For more info follow this link.

WHAT IS THE STATE OF PLAY OF THE IMPLEMENTATION OF EUDAMED

  • The development and implementation of EUDAMED is a high priority for the Commission
  • The Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional
  • The module on Actor registration will be the first module made available. Deployment of the module takes place at the latest by March 2021
  • The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be displayed as soon as they are functional.

UDI

  • Through implementing Decision (EU) 2019/939 of 6 June 2019, 4 issuing entities were designated to provide manufacturers with a list of UDIs to assign on medical devices.



醫療器械法規更新


發佈醫療器械協調小組(MDCG)指南

  • 醫療器械協調小組發佈了若干指南檔,對該行業產生了影響。 請點擊此連結瞭解適用於您組織的影響進行評估。

新型冠狀病毒 COVID-19

  • 與COVID-19相關的醫療器械(MDs和IVDs)清單已經提供。 請點擊此連結來瞭解具體產品。
  • 歐盟免費提供針對醫療供需品的醫療標準,以促進該類產品的產能。 有關更多資訊,請點擊此連結

歐盟醫療器械資料庫(EUDAMED)推行的最新資訊

  • 歐盟醫療器械資料庫的完善和推行是歐盟委員會的高優先順序事項
  • 委員會與醫療器械協調小組(MDCG)達成協議,不同模組上線後,會立即推行這些模組
  • 企業註冊模組是第一個上線的模組。 該模組最遲於2021年3月開啟。
  • UDI/器械註冊模組(第二個模組)和證書和公告機構模組(第三個模組)預計將於2021年5月啟用。在這之後,其餘的模組將逐步上線使用。

醫療器械唯一標識

  • 按照2019年6月6日歐盟第2019/939號決定, 4個機構被推薦給醫療器械製造商,這些機構可以向製造商提供用於醫療器械唯一器械標識的清單。
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