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CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

  • 2022-01-26 08:31:11

Clinical trial data is one of the important supporting documents for evaluating the safety and effectiveness of medical devices. Standardizing the collection, sorting, analysis, and submission of medical device clinical trial data will not only improve the quality of clinical trial implementation and management but also assist the regulatory agency to understand and review the development of clinical trials quickly and efficiently.

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QT Webinar: Japan Medical Device Registration

QT Webinar: Japan Medical Device Registration

  • 2021-09-06 06:11:51

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "Japan Medical Device Registration". Our event is scheduled to be held on September 17th (Friday), 2021.

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THAILAND:  Medical Device Registration Exemption Criteria, Methods and Conditions  prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

THAILAND: Medical Device Registration Exemption Criteria, Methods and Conditions prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

  • 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

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