Monthly CFDA News Roundup covers government announcement, 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.
When fully implemented, the label of all devices in China will include a unique device identifier in human- and machine-readable form. Within 60-day grace period, the license holder of the medical device shall upload the product identification and related data to CFDA UDI database.
For more information about the UDI draft plan, please click HERE.
For English version of the draft plan, please email info@ChinaMedDevice.com.
For more information about the Decree, please click HERE.
For official CFDA link of the Decree, please email info@ChinaMedDevice.com.
The standards also specify the modifications, effective dates, and give recommendations for registration application. CFDA will issue standards in 20 days after adoption, for the betterment of transparency of regulatory operation.
For more information about the Standard Revision Plan, please click HERE.
For official CFDA link of the Plan, please email info@ChinaMedDevice.com.
3 CFDA national chiefs and 7 provincial leaders have been demoted on August 16, as result of the recent vaccine scandal. Public awareness and government alertness over QMS system have been elevated to a new level.
For more information about the demotion, please click HERE.
CFDA issued 7 guidelines including 3 for IVDs:
Technical Review Guideline on Nasogastric Tube
Technical Review Guideline on Disposable Sterile Catheter
Technical Review Guideline on Custom Denture
Technical Review Guideline on Intrauterine Device
Technical Review Guideline on Methicillin-Resistant Staphylococcus Aureus (MRSA) Reagent
Technical Review Guideline on Chromosomal Abnormalities Detection Reagent
Performance Evaluation Guideline of Next Generation Sequencing (NGS) Based Cancer Biomarker
For official CFDA link of any guideline mentioned above, please email info@ChinaMedDevice.com.
Johnson & Johnson: Contact lens
Philips: Mobile digital x ray machine
GE: Single-photon emission computed tomography
Medtronic: Disposable cutterhead
DePuy Orthopaedics: Artificial knee joint
BioMérieux: Gram-positive bacteria flashcard (class I recall)
Biomet Orthopedics: Knee joint
Zimmer: Metal intramedullary nail
Mako Surgical: Orthopedic surgery navigation system
Arrow: Central venous catheter
Teleflex Medical: Disposable laryngeal tube
For the reasons of recall and the model numbers, please email info@ChinaMedDevice.com.
For more information about Clinical Inspection, please click HERE.
Aipute: Anchor Balloon Dilatation Catheter
For complete English version of the guideline, please email info@ChinaMedDevice.com.
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, RA, 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 250+ companies’ success.