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HONG KONG:  MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

HONG KONG: MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

  • 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

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QT ACTIVITY: Qualtech Shares Its Key Insights regarding China's New Regulations (RSAMD) via a Joint Webinar – JULY, 2021

QT ACTIVITY: Qualtech Shares Its Key Insights regarding China's New Regulations (RSAMD) via a Joint Webinar – JULY, 2021

  • 2021-08-02 06:36:08

On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.

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QT Webinar: China Medical Device Registration

QT Webinar: China Medical Device Registration

  • 2021-06-25 08:59:13

Qualtech Consulting would like to invite you to our free online Webinar on the subject of the ”China Medical Device Registration – New Regulation for Supervision and Administration of MDs (RSAMD)”, which has gone into effect on June 1, 2021.

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China: Notice on Registration of Medical Device Technical Dossier–May, 2021

China: Notice on Registration of Medical Device Technical Dossier–May, 2021

  • 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

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