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December 14, 2018
In order to strengthen the management of medical devices clinical trials, the National Medical Products Administration(NMPA, formally CFDA) launched the Notice of First Batch Medical Device Clinical Trial Inspection Results […]
December 14, 2018
From January 1st, 2019, China requires foreign company names to be provided in Chinese. The Chinese company name must meet following requirements: Use simplified Chinese. Chinese company name should be […]
December 10, 2018
NMPA (CFDA) published Guideline for Imported Medical Device Legal Agent (Draft) for feedback on Aug 3rd, 2018. The draft guideline lists 3 responsibilities for legal agents for the first time: […]
December 3, 2018
Do you know the NEW Registration Holder System for Medical Devices in China? Do you know the NEW post-market surveillance requirements in China? Do you know the latest clinical requirements […]
November 30, 2018
The compliance with the NMPA (CFDA) clinical trial requirements in China is getting more strictly audited and reinforced. On November 13th, NMPA (CFDA) issued the 2nd notification in 2018 for […]