CFDA implements this 3-year plan to support central government's effort to make medical device regulation more consistent with international standards. 300 standards for medical devices and IVDs could be expected by the end of 2020.
Keep up to date with CFDA changes and subscribe to our Weekly CFDA News Roundup. Click HERE or email info@ChinaMedDevice.com
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 Materials, Absorbable Implant Devices, New Biological Materials and Devices, Contact Lens and Intraocular Filling Materials.
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 adoption, for the betterment of transparency of regulatory operation.
Keep yourself updated with CFDA monthly changes, click HERE to opt-in. For our market access monthly newsletter, click HERE
For more detailed information or translated English version of all the documents, please contact us at info@ChinaMedDevice.com
About China Med Device, LLC
We provide turn-key solutions for western medical device/IVD companies to enter China with regulatory and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our management team in Boston and Beijing have processed 1,200+ certificates. Email info@ChinaMedDevice.com or visit www.ChinaMedDevice.com
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------