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Announcement on Review Results for Medical Devices’ Priority Approval Application (2019 No.6)

302019-05

Announcement on Review Results for Medical Devices’ Priority Approval Application (2019 No.6)
China NMPA announced the following enterprise whose applications have acquired priority approval: Medtronic Inc. and Ustar Biotechnology Ltd.The details of the approval as...
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NMPA Notice on Guidelines of the Registration Technical Review for Synthetic Resin Teeth and Other Two Products

242019-05

NMPA Notice on Guidelines of the Registration Technical Review for Synthetic Resin Teeth and Other Two Products
China NMPA has recently published “Guidelines of Registration Technical Review for Synthetic Resin Teeth”, “Guidelines of Registration Technical Review for Intrau...
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NMPA Issued the Guidelines of the Registration Technical Review on the Shelf Life of Active Medical Device

172019-05

NMPA Issued the Guidelines of the Registration Technical Review on the Shelf Life of Active Medical Device
China National Medical Product Administration (NMPA) has recently published a notice for “The guidelines of registration technical review on the shelf life of active medic...
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NMPA Announced 25 Batches of Medical Device Products That Did Not Comply with the Standard Regulations

142019-05

NMPA Announced 25 Batches of Medical Device Products That Did Not Comply with the Standard Regulations
Notice regarding the Inspection Result from The Center for Medical Device Evaluation (CMDE)In an effort to strengthen the management of quality control and to ensure the...
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Notice on the Application for Certificate Authority (CA) for Medical Device Registration Electronic Information System

142019-05

Notice on the Application for Certificate Authority (CA) for Medical Device Registration Electronic Information System
According to the request of General Office of the Communist Party of China and General Office of the State Council, National Medical Product Administration (NMPA) h...
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Official Announcement on Four Medical Organizations within Hong Kong Special Administrative Region of the People's Republic of China in Charge of Domestic Clinical Trials (Published on April 30, 2019)

092019-05

Official Announcement on Four Medical Organizations within Hong Kong Special Administrative Region of the People's Republic of China in Charge of Domestic Clinical Trials (Published on April 30, 2019)
Published on Jun 28, 2019China NMPA announced the following enterprises whose applications fully comply with the prerequisite criteria and are accepted into the special review...
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