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CFDA Requires Applicant Name of Foreign Medical Device to Be in Chinese - November 2017

CFDA Requires Applicant Name of Foreign Medical Device to Be in Chinese - November 2017

  • 2020-02-15 06:22:45

According to the “Regulations for the Supervision and Administration of Medical Devices,” "Provisions for Medical Device Registration,” “Provisions for In-vitro Diagnostic Reagent Registration,” and “Provisions for Instructions and Labels of Medical Devices,” when applying for medical device listing in China, the applicant name shall be in Chinese.

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 TFDA Holds Conference for 3D Printing Guideline Draft in Taipei - November 2017

TFDA Holds Conference for 3D Printing Guideline Draft in Taipei - November 2017

  • 2020-02-15 06:16:53

n order to ensure that the 3D printing production of medical equipment is scientific, safe and effective, and to uphold consumer protection, the Taiwanese Food and Drug Administration (TFDA) commissioned the national Cheng Kung University to develop a draft of "the product management guideline for 3D printing medical device,” which is applicable to medical devices which use 3D printing technology in their manufacturing process.

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