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2026 China NMPA Bluebook is here:
On June 11, CFDA published “4th Batch of Clinical Exempted Medical Devices and IVDs (Draft)” for feedback. 85 medical devices and 277 IVDs have been
The GCP requirements on medical devices have intensified. On June 25, CFDA issued the first notification in 2018 for the upcoming clinical inspections for 9
On June 25, China State Council released a draft amendment to overhaul the medical device regulations. On June 27, Grace Palma, CEO of China Med Device,
The last time the NMPA (CFDA) “Medical Device Supervision and Management Regulations” were completely overhauled was in 2014 with a supplemental update in 2017. Today
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
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
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
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
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
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
CFDA granted 4 medical devices Innovation Approval, and 1 device Priority Review on May 22. Johnson & Johnson and Medtronic are on the list. Innovation
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