CFDA issued "Medical Device Standards Planning 2018-2020" on Jan.29, 2018.
Based on this New Standards Planning, CFDA will establish and revise about 300 Medical Device Standards from 2018 to 2020, the key standards include the following scopes:
1. Medical Device Quality Management Standardization key fields
Medical Device Quality Management field, Medical Device Risk Management field and Medical Device Clinical Trial field.
2. Active Medical Device Standardization Key Fields
(1). Speed up International Medical Electrical Equipment General and Specific standards convert to domestic standards, establish general basic standards and related implementation plan and training materials.
(2). Medial Robot, Active Implant, Medical Software, PET-MRI multi-tech combination, Respiratory and Anesthesia machine, Medical Device Disinfection and Sterilization Devices, Intra-oral Digital Radiography, Medical Extracorporeal Circulation Equipment, Radiation Therapy and Nuclear Medicine, Ultrasound, Physics Therapy, Medical Laboratory, X-ray Diagnosis and Medical Laser fields.
3. In-active Medical Device Standardization Key Fields
(1). Speed up International Medical Device Biological Evaluation Standards conversions, further improve General and Specific Biological Evaluation Methodology's standardization system.
(2). New Surgical Equipment, New Infusion Apparatus, Birth Control, Reproductive and Contraceptive Devices, New Medical joint, New Hygienic Materials and surgical dressing, additive manufacturing (as 3D printing), Dental Digital Materials Quality Evaluation, Tissue Engineering, Nanometer Medical Device, Allogeneic Materials, Absorbable Implant Devices, New Biological Materials and Devices, Contact Lens and Intraocular Filling Materials.
4. IVD
Traceability and Reference Measurement System, Molecular Diagnosis Techniques such as High Throughput Sequence, Mass Spectrum techniques in IVD, Infectious Diseases IVD Agents and POCT.
Please pay more attention to the above mentioned medical device standards changes or new standards in the upcoming 3 years.
The link to original document was issued by CFDA only in Chinese is as follows: http://www.sfda.gov.cn/WS01/CL0845/223587.html
If you are interested in this Medical Device Standards Planning with more detailed information, please feel free to contact julianiu@ramed.top.
RAMED Biosciences provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.