CFDA Issued Three New Medical Device Registration Guidelines - Regulatory News - Medical Devices

September 13^th 2017, China Food and Drug Administration (CFDA) issued three new registration guidelines.

Guideline List

Infrared Breast Examination Instrument Registration Guidelines (2017 revised version)
Medical Ozone Gynecological Therapeutic Apparatus Registration Guidelines (2017 revised version)
Bone Tissue Surgery Equipment Registration Guidelines (2017 revised version)

Guideline Applicable Scope

Guideline	Applicable Scope
Infrared Breast Examination Instrument Registration Guidelines (2017 revised version) CN: 紅外乳腺檢查儀注冊技術審查指導原則（2017年修訂版）	This guideline applies to the mammary gland detection devices by infrared radiations method. According to the ‘Medical Device Classification Catalog’, the MD code is Class II 6821 medical electronic equipment.
Medical Ozone Gynecological Therapeutic Apparatus Registration Guidelines (2017 revised version) CN:醫用臭氧婦科治療儀注冊技術審查指導原則（2017年修訂版）	The guideline applies to the ozone treatment preparation for gynecological diseases. According to the ‘Medical Device Classification Catalog’, the MD code is Class II 6826 physical therapy equipment.
Bone Tissue Surgery Equipment Registration Guidelines (2017 revised version) CN: 骨組織手術設備注冊技術審查指導原則（2017年修訂版）	This guideline applies to the network power supply, battery or specific power supply for surgery tools (such as drilling, sawing, grinding, milling, shaver, etc.). To perform surgical treatment of human tissue in surgery or orthopedic surgery. (Such as drilling, milling, cutting, grinding, etc.). And the non-therapeutic bone tissue surgical equipment that is used for the planing of organisms’ hard tissues and soft tissues in surgery, orthopedics or otolaryngology and cosmetic surgery.

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