Blog

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: […]
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 […]
November 9, 2018

Our Client, RTI Surgical®, to Acquire Paradigm Spine

Congratulate our client and long-term partner, RTI Surgical, on acquiring Paradigm Spine! RTI Surgical, a global surgical implant company, has signed an agreement to acquire Paradigm Spine, a leader in […]
November 8, 2018

NMPA(CFDA) Suggests Improving Definition Process and Transparency of Combination Products

With the development of the medical technology, the NMPA(CFDA) started to strengthen the management of the combination products. In 2018, CFDA held a symposium on “Preliminary attribute definition and evaluation […]
November 6, 2018

CFDA Monthly Roundup (October)

Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com), […]
November 1, 2018

CFDA: 27 Medical Device Guidelines Released in One Day

CFDA issued 27 device guidelines on Oct.8th, covering benefit-risk assessment, cardiovascular, urology and orthopedic devices and immune oncology IVDs, etc. Whether you are renewing or doing new registration, your medical […]
October 30, 2018

China Med Device, LLC to Present on New England Healthcare Executive Network

NEW ENGLAND HEALTHCARE EXECUTIVE NETWORK MEETING CHINA’S FUNDING OPTIONS AND MARKET ACCESS ACCELERATE TIME TO MARKET IN CHINA’S HEALTH SYSTEM NOVEMBER 5, 2018, 7:30AM TO 10:00AM Location: FOLEY HOAG LLP […]