February 09, 2018

Medical device standards are a unified basis for the development, production, operation, use and management of medical devices. These are also important indications of the development of medical device industry. In order to optimize the standard management mechanism of medical devices, CFDA has released the three-year plan (2018-2020) for medical device standards. The objectives of the 3-year plan are as follows:

1.   To promote the revision of standards in major areas with particular needs in:

(1)    Medical Device Quality Management: For example, "Medical Device Quality Management", "Medical Device Risk Management", "Medical Device Clinical Trial Management"

(2)    Active Medical Devices: Some standards were updated, such as medical robots, active implants, and medical software. In addition, the multi-technologymedical devices were also included such as PET-MRI, medical respiration and anesthesia equipment. The medical equipment for sterilization, the field of oral digital equipment, the field of radiotherapy and nuclear medicine equipment, the medical ultrasound equipment, the physical therapy device, the medical laboratory equipment, the X-ray diagnostic equipment, and medical laser equipment. "

(3)    Non-active Medical Devices: Some standards were updated, such as "Newly-designed surgical instruments, newly-designed infusion devices, auxiliary reproductive devices, newly-designed medical connectors, hygienic materials and dressings, the field of oral digital material, tissue engineering, nano-related medical devices, allogeneic materials, absorbable implants, new biomaterials and their products, contact lens care products, eye filler."

(4)    In-vitro diagnostic medical devices: such as "traceability and reference measurement systems, high-throughput sequencing and other new molecular diagnostic techniques, mass spectrometry in the clinical applications, infectious diseases, in vitro diagnostic reagents, POCT field. "

2.   To strengthen the relationship between CFDA and International Standard Organizations (e.g., Verband Deutscher Elektrotechniker (VDE), the American Institute of Electrical and Electronics Engineers (IEEE), etc.).

3.   To establish the standardization of medical device information thruogh an online platform. This will result in a faster information dissemination of applicable standards for the management of certain medical devices. The users can download the standards and inquire on the platform.



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