Monthly CFDA News Roundup (January 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.

Policies:

1. CFDA announced initiation of marketing-authorization holders program for medical devices in Shanghai on Jan 5^th.
2. CFDA issued standardization plan for medical devices (2018-2020) on Jan 29^th. Development of standardization for active device, passive device and IVD are addressed.

Industry Standards:

CFDA issued 9 industry standard documents on Jan 24^th:

• 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

Guidelines:

CFDA issued 14 technical review guidelines from Jan 3^rd to Jan 10^th:

• 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

QA/recall/AE:

1. CFDA issued adverse event alerts on powdered medical gloves and disposable delivery kit on Jan 16^th.
2. CFDA issued recalls for 81 medical products from Jan 3^rd to Jan 30^th. They are 47 foreign manufacturers on the list, including Smith & Nephew, Philips, GE, Hologic, Thermo Fisher, Siemens, etc.

Approvals:

1. CFDA granted 4 approvals for innovative medical device through breakthrough therapy program on Jan 10^th.

• 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

2. CFDA granted approval for epidermal growth factor receptor (EGFR) mutation test kit on Jan 19^th. This is the first CFDA approved device indicated for non-small cell lung cancer.
3. CFDA issued directory of registered medical devices on Jan 22^nd. There 22 imported class III and 49 imported class II devices on the list.
4. CFDA granted approval for absorbable dura sealant on Jan 31^st. This is the first CFDA approved device indicated as a dura substitute for the repair of dura mater.

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, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.