Monthly CFDA News Roundup covers policies, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.
- Hainan has become the first independent province for imported medical device approval, followed by the establishment of Hainan Free Trade Zone.
- Quality requirement has escalated. Newly-instituted CFDA issued second national quality notice since March 2018; Shanghai published the first local recall report.
- CFDA issued directory of medical device approvals for March 2018. 52 domestic devices, 8 imported class III and 34 imported class II devices have been approved.
Hainan has been granted to be the first independent province for imported medical device approval, China State Council announced on April 4th. Imported medical devices can be clinically used in Boao City, Hainan province without CFDA registration approval, as long as they are approved by Hainan Province FDA office. Read More
On April 13th, Chinese President Xi Jinping announced that Hainan has been established to be the first provincial free trade zone.
CFDA issued 7 Technical Review Guidelines in April 2018:
- Active device: Technical Review Guideline on Insufflator
- Active device: Technical Review Guideline on Medical Cooler
- Active device: Technical Review Guideline on Electrical Urinometer
- Active device: Technical Review Guideline on Electrical Vaginal Microscopy
- Active device: Technical Review Guideline on Oral Surface X-Ray Machine
- Passive: Technical Review Guideline on Soft Lense
- IVD: Technical Review Guideline on Assisted Reproduction Water
- Shanghai published the quarterly recall report. Total 63 medical devices have been voluntarily recalled in Shanghai for the first quarter of 2018, including 58 imported devices (92%) and 5 domestic devices (8%). Foreign manufacturers include Roche, Siemens, GE, Philips, Abbott, Becton Dickinson, Boston Scientific, Smith&Nephew, etc. This is the first recall report published by local CFDA office. Read More
- CFDA announced recall notices from 15 foreign manufacturers for 20 medical devices. Philips, GE, Medtronic, Smith&Nephew, Boston Scientifics and Becton Dickinson are on the list.
- Philips: infant incubator
- Philips: x-ray angiographic system
- Philips: defibrillator
- GE: mobile x-ray system
- GE: infant incubator
- Medtronic: heater/cooler system
- Medtronic: plasma filter
- Smith & Nephew: locking plate
- Smith & Nephew: bone needle
- Boston Scientific: pelvic floor repair system
- Becton Dickinson: vacuum blood collection tube
- Edwards Lifesciences: oximetry monitor
- Stryker: ultrasonic surgical aspirator system
- Maquet: ventilator
- Zimmer Biomet: hip stem
- Beckman Coulter: automatic urine analyzer
- Mindray: automatic immunoassay analyzer
- Bellco Hoxen: plasma filter
- Biotronik: peripheral stent
- Deerfield Imaging: MRI system
- CFDA issued national quality notice #2 (2018). Defects have been found on 26 medical devices from 19 manufacturers, and labeling issues have been found in 12 medical devices. 2 foreign manufacturers are:
- Riben Gongye Zhushihuishe (エレクトロニクス工業株式会社): electric potential therapy device
- Limmer Laser GmbH: intensive phototherapy
- CFDA published directory of medical device approvals for March 2018. 52 domestic, 8 imported class III and 34 imported class II devices have been approved. GE, Medtronic, Abbott, Boston Scientific, FUJIFILM, Bayer are on the list. For the complete list of manufacturers, please email info@ChinaMedDevice.com
For more detailed English documents, please contact us at info@ChinaMedDevice.com
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing and Boston. Our management team has 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.