December

December 21, 2018

ChinaMed Device, with Goldman Sachs and Other Industry Leaders, Interviewed by Bloomberg on European Effects of U.S-China Trade War

On Dec 18, ChinaMed Device, LLC is interviewed by Bloomberg on European effects of U.S-China Trade War. Other interviewees include Goldman Sachs, BS Global Wealth Management, and European Union Chamber […]
December 18, 2018

What are the CFDA interpretation of the combination products attributes?

In order to guide the applicant to make proper application, NMPA(CFDA) has published the summary of the attribute definition results of drug-device combination products starting from 2009 to the present. […]
December 14, 2018

9 Clinical Trials Have Compliance Issues in NMPA Inspection

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

NMPA (CFDA): Be Prepared to Have Company Name in Chinese on Your Device Label and IFU

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

3 New Requirements for Legal Agent in China

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: […]