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) a consulting firm specializing in China CFDA regulatory, CRO and market access services.
Hainan government published “Registration Guidance on Urgently Needed Imported Medical Device”. The Guidance specifies the application dossier preparation for initial registration, renewal and supplement. The devices need to be home-country-approved. Within 7 days, Hainan CFDA office shall notify the applicant whether if the medical device has been approved. For State Council’s announcement on Hainan medical device policy, click Here.
For English version of the guidance, please email info@ChinaMedDevice.com.
CFDA issued two draft guidelines for feedback. Feedbacks need to be summited by July 20.
- Ophthalmology: Clinical Trial Guideline of Femtosecond Laser for Cutting Corneal Flap (draft)
- Oncology: Technical Review Guideline on Disposable Biopsy Needle (draft)
CFDA announced recall notices from 3 foreign manufacturers:
- Johnson & Johnson: polypropylene non-absorbable suture
- Stryker: intramedullary nail
- Biomet: knee meniscus component
CFDA issued innovation approval notice (2018 No.7) to 5 domestic medical device manufacturers. No foreign companies are on the list.
- Genomics: BRCA1/2 gene mutation detection kit
- Xiansida: oligosaccharide detection kit
- Hangtian Taixin: ventricular assist device
- Seemine SMA: memory alloy wrist fixator
- Shenzhen Jingcheng: magnesium-degradable bone repair material
For translated innovation approval draft guideline, please email 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, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.