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SFDA Medical Devices Classification

 

Form of Operation/Type of device Contracting or inserted Device 
Temporary Use Short-term use Long term use
Skin,Cavity and Tract Trauma Tissue Blood Circulation Central Circulation Skin,Cavity and Tract Trauma Tissue Blood Circulation Central Circulation Skin,Cavity and Tract Trauma Tissue Blood Circulation Central Circulation
Passive Device Device for transportation and storage of pharmaceutical liquid 2 2 3 2 2 3 2 3 3
Device for alternation of blood and body fluid / / 3 / / 3 / / 3
Device for medical dressing 1 2 2 1 2 2 / / /
Surgical instrument (inserted) 1 2 3 2 2 3 2 3 3
Reusable surgical instrument 1 1 2 / / / / / /
Disposable aseptic surgical device 1 2 3 2 3 3 2 3 3
Implantables / / / / / / 3 3 3
Device for contraception and birth control 2 2 3 2 3 3 3 3 3
Device for sterilization and cleaning 2 2 2 2 2 2 2 2 2
Other contacting passive device 1 2 3 2 2 3 2 3 3
Active Device Device for Treatment through energy 2 2 3
Device for diagnostic monitoring 2 2 3
Device for body fluid transportation 2 3 3
Device for ionized radiation 2 3 3
Other general active device 2 2 /
 
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