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​相關證書

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ISO 13485

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002, the previously published ISO 13485, and ISO 13488.

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GMP

GMP Certification in Taiwan Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product in Taiwan.

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CE

CE marking is an administrative marking with which the manufacturer or importer affirms its conformity with European health, safety, and environmental protection standards for products sold within the European Economic Area. It is not a quality indicator or a certification mark. The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense like the FCC Declaration of Conformity used for selling certain electronic devices in the United States.

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中華民國專利證書

為落實行政院四大新興智慧型產業「發明專利產業化」政策，提升發明專利審查效能，加速產業創新應用之重大政策目標，經濟部智慧財產局(以下簡稱智慧局)於民國99年1月5日研提「經濟部智慧財產局清理專利積案計畫」，同年6月24日經行政院同意參考日本及韓國將專利申請案前案檢索等事項委託審查之方式，由政府出資捐助成立外圍組織財團法人專利檢索中心，並於民國101年3月15日正式登記成立。

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中華民國專利證書

為落實行政院四大新興智慧型產業「發明專利產業化」政策，提升發明專利審查效能，加速產業創新應用之重大政策目標，經濟部智慧財產局(以下簡稱智慧局)於民國99年1月5日研提「經濟部智慧財產局清理專利積案計畫」，同年6月24日經行政院同意參考日本及韓國將專利申請案前案檢索等事項委託審查之方式，由政府出資捐助成立外圍組織財團法人專利檢索中心，並於民國101年3月15日正式登記成立。

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​歷年獎項

  • 2010 – MD-670P+ – MEDIPHAR TAIPEI, Excellence Award

  • 2007 – 康定公司 – 台灣醫療生技同業公會 同業楷模獎

  • 2005 – MD-750 – 藥物科技研究發展 銅質獎

  • 2004 – MD-680P – 台北國際醫療暨生技展 創意新產品獎

  • 2004 – MD-680P – 藥物科技研究發展 銀質獎

  • 2000 – HD-21 – 經濟部創新研究獎

  • 1999 – MD-600P – 經濟部創新研究獎

  • 1999 – HD-21 – 經濟部台灣精品獎

  • 1998 – HD-7/HD-11 – 經濟部創新研究獎

  • 1997 – MD-600P – 經濟部台灣精品獎

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