營業項目：產品查驗登記

• QSD 品質系統文件、PMF工廠資料查驗登記、CGMP確效
• 領證後之法規事務維護及管理
• 國內許可證之保管、維護及管理
• 國內臨床試驗或bridging studies之計畫書(Protocol)，執行，協調工作
• 藥品，醫療器材健保給付價申請事務
• 國內行銷或銷售人員之產品訓練課程
• 醫療器材－Class I,II,III,以及IVD
• 藥品－新藥、學名藥（包含處方藥、指示用藥、成藥）
• 膠囊狀以及錠狀食品
• 含藥化妝品
• 動物用藥，疫苗

大家好，

 AMERICAS | ASIA PACIFIC | EMEA

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ISO 13485:2003 is a quality system standard designed specifically for medical device companies, and is the most commonly chosen path for companies to meet the QMS requirements in Europe, Canada, Japan, Australia and other countries.The ISO 13485 standard has many of the same requirements as ISO 9001:2008. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer feedback and more.

Although implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada, ISO 13485:2003 is mandatory for Class II, III and IV medical device manufacturers, with additional requirements imposed under Canadian law. Compliance with Japan’s Ministerial Ordinance #169 is quite similar to ISO 13485 with additional requirements imposed under Japan law.

Medical Device Vigilance Reporting in Taiwan

修正前後比較

2014下半年 查驗登記新規定

醫療器材優良流通規範 (草案)

想把鏡片賣給大陸嗎?首先要通過CFDA審查

其中鏡片著色劑部分是審查重要標準之一