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 China Med Device, LLC (www.ChinaMedDevice.com) a consulting firm specializing in China CFDA regulatory, CRO and market access services.
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Highlights:
- Innovative Medical Device Special Approval Procedures will propel China to the leadership in market acceptance of innovative applications. Meanwhile, 4 cardiovascular companies got innovation approvals this month.
- 2017 Medical Device Adverse Event Report and 2018 National Inspection Plan of Medical Devices have been published; 2 class I recalls issued.
- 2018 Medical Device Industry Standard Revision Plan, covering 99 standards, has been announced; 9 technical review guidelines issued.
Policy
- CFDA issued “Innovative Medical Device Special Approval Procedures (Revised Draft for Feedback)”. It specifies the additional documents for foreign manufactures to apply for the special approval. Within 60 days after the application is received by CFDA, the agency will notify the applicant whether it has been approved. Read More
- Hainan provincial government published “Regulation for Urgently Needed Imported Medical Devices in Hainan”. Before CFDA registration approval, imported medical device can be clinically used in qualified healthcare facilities.
- CFDA announced “2018 National Inspection Plan of Medical Devices”. The Plan covers orthopedics, dental devices, IVDs, etc. It specifies inspection items, related standards, responsible departments, and procedure of inspecting, retesting and appealing.
For English version of above documents, please email info@ChinaMedDevice.com
Government Report
CFDA issued “2017 Medical Device Adverse Event Report”. China National Adverse Event Surveillance Center received 376,157 reports in the year of 2017, increased by 6.49% from 2016. Reports from healthcare facilities account for 86.83% of the total, and those from manufacturers account for 10.83%. In terms of device category, Class III and Class II devices account for 40.99% and 48.16% of the total respectively.
The 10 most reported medical devices are:
For English version of the Report, please email info@ChinaMedDevice.com.
Standard
CFDA issued “2018 Medical Device Industry Standard Revision Plan” for feedback. The Plan covers 99 industry standards for medical devices and IVDs, such as mass spectrometer, assisted reproduction device and 3D printed dental device.
For English version of the Plan, please email info@ChinaMedDevice.com.
Guideline
CFDA issued 9 guidelines in the month of May:
- Active device: Technical Review Guideline on Surgical Microscope
- Active device: Technical Review Guideline on Tonometer
- Active device: Technical Review Guideline on Pulse Wave Velocity and Ankle-Brachial Index Product
- Active device: Technical Review Guideline on Electronic Laryngoscopy
- Active device: Technical Review Guideline on Endoscope Reprocessor
- Active device: Technical Review Guideline on Apnea Monitor
- Passive device: Technical Review Guideline on Cleaning Bench
- Passive device: Pre-Clinical Trial guideline on Coronary Drug-Eluting Stent
- Passive device: Clinical Trial Guideline on Coronary Drug-Eluting Stent
QA/recall/AE
CFDA announced recall notices from 21 foreign manufacturers for 27 medical devices. GE, Philips, Siemens, Medtronic, Abbott, BD are on the list.
Among them are 2 class I recalls: implantable defibrillator by Abbott, and blood lead analyzer by Magellan. Class I recall is the most urgent type of recall CFDA issues. Read More……
- Smith & Nephew: 1) locking plate; 2) bone needle; 3) knee surgical device; 4) external fixation system; 5) RF plasma surgery system
- Philips: 1) infant incubator; 2) x-ray angiographic system; 3) defibrillator
- GE: 1) mobile x-ray system; 2) x-ray bone density detector; 3) infant incubator
- Medtronic: 1) heater/cooler system; 2) plasma filter
- Boston Scientific: 1) pelvic floor repair system; 2) pacemaker wire
- Abbott: implantable defibrillator
- Magellan: blood lead analyzer
- Siemens: gentamicin assay kit
- 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
- Biomet Othopedics: knee replacement
- ConvaTec: intra-abdominal pressure monitor
- DiaMed: blood grouping reagent IH-card
For the reason of recall and the model number, please email info@ChinaMedDevice.com.
New Approval
- CFDA published Directory of Registered Medical Devices for April 2018. 52 domestic class III, 23 imported class III and 32 imported class II medical devices have been approved. GE, Siemens, Medtronic, Abbott, Johnson & Johnson, BD, Baxter are on the list.
- CFDA granted Innovation Approvals to 4 cardiovascular devices manufacturers:
- Medtronic: percutaneous implanted aortic valve system
- Biosense Webster(Israel): 3D multichannel radiofrequency balloon catheter
- Quanjing Hengsheng: intravascular imaging system
- Aipute: pressure-induced ablation catheter
- CFDA granted Priority Review status to silk fibroin film, by XingyueBio.
For regulations about CFDA Innovation Approval and Priority Review, please contact us at info@ChinaMedDevice.com
Keep yourself updated with CFDA News Roundup, click HERE to opt-in. We also publish market access newsletter, click HERE
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, post market compliance. We are certified as legal agent. 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+ companies’ success.