CFDA Updates

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: […]
December 3, 2018

Era of transformation: 2018 NMPA (CFDA) Major Regulation Updates

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

More IVD Clinical Trials to Receive NMPA (CFDA) Clinical Audit

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 […]
November 26, 2018

NMPA (CFDA) New IVD Clinical Guideline: 11 Requirements You Should be Prepared for!

NMPA (CFDA) published draft IVD Clinical Trial Guideline for feedback on November 22nd, 2018 during the U.S. Thanksgiving holiday. After initial clinical guideline issued in September 2014, NMPA (CFDA) has […]