6 Foreign Devices Recalled Last WeekFebruary 8, 2018
CFDA: Be Prepared to Have Company Name in Chinese on Your Device LabelFebruary 8, 2018
Monthly Updates Digest from CFDA edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.
News coverage area: CFDA policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.
- CFDA announced initiation of marketing-authorization holders program for medical devices in Shanghai on Jan 5th.
- CFDA issued standardization plan for medical devices (2018-2020) on Jan 29th. Development of standardization for active device, passive device and IVD are addressed.
CFDA issued 9 industry standard documents on Jan 24th:
- Anesthesia: industry standard of oxygen humidifier
- Dental: industry standard of hose assembles for dental pneumatics
- Dental: industry standard of root canal preparation for dental use
- Dental: industry standard of rotary polishing device for dental use
- Diagnostics: industry standard of technical characteristics of c-arm x-ray
- Hematology: industry standard of continuous hemodialysis machine
- Orthopedics: industry standard of ultrasonic bone tissue surgery equipment
- Sterilization: industry standard of products and processes of moist heat
- Urology: industry standard of camera system for endoscope
CFDA issued 14 technical review guidelines from Jan 3rd to Jan 10th:
- Cardiology: technical review guideline on Insulin assay reagent
- Clinical trial design: clinical trial design guideline on medical devices
- Hematology: technical review guideline on Apolipoprotein B assay reagent
- Hematology: technical review guideline on Apolipoprotein A1 assay reagent
- Hematology: technical review guideline on plasma concentration system
- Hematology: technical review guideline on Homocysteine assay reagent
- Hematology: technical review guideline on whole blood and blood components storage bag
- Hematology: technical review guideline on Alanine Amino transferase assay reagent
- Hematology: technical review guideline on disposable infusion pump (non-electrical source)
- Hematology: technical review guideline on D-dimer assay reagent (Immunoturbidimetry)
- Hematology: technical review guideline on C-peptide assay reagent
- International clinical trial: guideline on acceptance of international clinical data for medical devices
- Oncology: technical review guideline on clinical evaluation of proton/carbon ion therapy system
- Urology: technical review guideline on urinalysis reagent strip
- CFDA issued adverse event alerts on powdered medical gloves and disposable delivery kit on Jan 16th.
- CFDA issued recalls for 81 medical products from Jan 3rd to Jan 30th. They are 47 foreign manufacturers on the list, including Smith & Nephew, Philips, GE, Hologic, Thermo Fisher, Siemens, etc.
- CFDA granted 4 approvals for innovative medical device through breakthrough therapy program on Jan 10th.
- United Imaging: Medical Linear Accelerator System
- Edwards Lifesciences: Transcatheter heart valve and accessory
- Bohui: Repair patch with Anastomotic stoma
- RaySoultion: Positron emission and X-ray tomography scanning system
- CFDA granted approval for epidermal growth factor receptor (EGFR) mutation test kit on Jan 19th. This is the first CFDA approved device indicated for non-small cell lung cancer.
- CFDA issued directory of registered medical devices on Jan 22nd. There 22 imported class III and 49 imported class II devices on the list.
- CFDA granted approval for absorbable dura sealant on Jan 31st. This is the first CFDA approved device indicated as a dura substitute for the repair of dura mater.