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CHINA: CFDA publishes the notice on examination of medical device - January 2018

CHINA: CFDA publishes the notice on examination of medical device - January 2018

  • 2020-02-14 14:54:11

Before undergoing registration application in China, medical devices shall be sent to medical device inspection agencies for examination to ensure that the products meet national standards. CFDA has issued a notice on the examination work to ensure the efficiency of registration of medical devices. The details of the notice are as follows:

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China: CFDA releases the interpretation of the basic requirements of the clinical evaluation for IVD reagents exempt from the clinical trials - December 2017

China: CFDA releases the interpretation of the basic requirements of the clinical evaluation for IVD reagents exempt from the clinical trials - December 2017

  • 2020-02-14 15:22:02

The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.

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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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