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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.



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.



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.



  • 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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