Blog

June 25, 2018

CFDA Cracking Down on Labeling—36% Defects Have Labelling Issues

On June 22, CFDA published Quality Notice #47 and identified 64 defects for 9 types of medical devices: nerve and muscle stimulator, ultrasonic atomizer, disposable vaginal dilator, insulin pimp, oxygen […]
June 23, 2018

Weekly CFDA News Roundup (June 11th to June 18th) 

Weekly CFDA News Roundup covers government reports, 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) […]
June 14, 2018

CFDA:Regulation Updates for Blood-Related Medical Device

This year, CFDA has issued 8 technical guidelines, 1 innovation approval and 1 class I recall for blood-related medical devices. Guideline: Technical Guideline on Continuous Glucose Monitoring Device; Technical Guideline […]
June 13, 2018

Weekly CFDA News Roundup (June 3rd to June 10th)

Weekly CFDA News Roundup covers government reports, 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) […]
June 11, 2018

Monthly CFDA News Roundup (May 2018)

Monthly CFDA News Roundup covers policies, government reports, 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) […]
June 8, 2018

It’s Official: CFDA Innovation Approval Guideline Effective Dec 1, 2018

On November 5, 2018, NMPA (CFDA) published final guideline “Special Review and Approval Procedure for Innovative Medical Devices” per CFDA notice No.13 2014. The guideline focuses on establishing a gradation […]
June 6, 2018

New Batch of Innovative and Priority Devices was Approved by CFDA; J&J and Medtronic were Included

CFDA granted 4 medical devices Innovation Approval, and 1 device Priority Review on May 22. Johnson & Johnson and Medtronic are on the list. Innovation Approvals: Medtronic: percutaneous implanted aortic […]
June 6, 2018

CFDA: Abbott and Magellan Got Level I Recall

CFDA quality requirements have escalated. In the month of May, CFDA announced 31 Medical Device Recall Notices from 21 foreign manufacturers. 1.      There are 2 level I recalls; level I […]
May 30, 2018

Join Our Webinar: Key Ingredients for Effective China SDA(CFDA) CER and Clinical Trial

Which is your clinical pathway in China, CER or Clinical Trials? How to get oversea clinical data accepted by China SDA? How can you use CFDA unapproved device in China […]
May 29, 2018

Weekly CFDA News Roundup (May 20th to May 26th)

Weekly CFDA News Roundup covers government reports, policies, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) a […]
May 24, 2018

Big Opportunity in Precision Medicine Market

The global application of molecular diagnostics has gradually evolved from the initial diagnosis of infectious diseases to the current personalized treatment and genetic disease screening, which has highly promoted precision […]
May 24, 2018

Immuno-Diagnostics: Continuous Growth Market in China

According to the statistics of China Blueprint for In Vitro Diagnostic, as of 2016, the size of China’s immunodiagnostic market reached 16.2 billion RMB (2.61 billion USD), accounting for 33% […]