CFDA implements this 3-year plan to support central government’s effort to make medical device regulations more consistent with international standards. 300 standards for medical devices and IVDs could be expected by the end of 2020.
1. Active Device Standardization
Focused areas: Medial Robot, Implantable Device, Medical Software, PET-MRI, Respiratory and Anesthesia Equipment, Disinfection and Sterilization Devices, Digital Radiography, Medical Extracorporeal Circulation Device, Radiation Therapy and Nuclear Medicine, Ultrasonic Equipment, Medical Laboratory and X-ray Equipment.
2. Passive Device Standardization
Focused areas: Novo Surgical Equipment, Infusion Device, Assisted Reproductive Technology (ART), Surgical Dressing, 3D Printing, Dental Digital Material, Tissue Engineering, Nanometer Medical Device, Allogeneic Material, Absorbable Implant Device, New Biological Materials and Device, Contact Lens and Intraocular Filling Material.
3. IVD Standardization
Focused areas: High Throughput Sequencing (HTS), Mass Spectrometry IVD, IVD for Infectious Diseases and Posterior Occipital Cervical Thoracic (POCT) System.
4. Quality Management Standardization
The Plan also addresses the quality management and international cooperation issues. CFDA will increase the threshold for medical device quality system. The exchange of staff and idea with other countries and international standard associations is to be speeded up, accelerating the improvement of standardization system. For the digital management of standard system, CFDA will publicize content of standards in 20 days after official adoption, for the betterment of transparency of regulatory operation.
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.