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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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Important Note
Due to the reorganization of the Chinese government in 2018,
CFDA (China Food and Drug Administration) was renamed to NMPA (National Medical Product Administration), and its food supervision function has been transferred to SAMR (State Administration for Market Regulation of China);
GACC (General Administration of Quality Supervision, Inspection and Quarantine of China) was abolished, and its import and export trade supervision function has been transferred to GACC (General Administration of Customs of China),
Therefore, all
CFDA and SFDA on this website default to NMPA, GACC defaults to GACC; 
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