--- source: https://asaptic.com/standard/product/medical-device title: China export standards for Home/clinical medical device - Cross-Standard | Asaptic description: Cross-Standard comparison pages for Home/clinical medical device, grouped by destination market. --- # China export standards for Home/clinical medical device - Cross-Standard | Asaptic CROSS-STANDARD · TOPIC PILLAR # China export standards for Home/clinical medical device Home-use and clinical medical devices—ranging from diagnostic monitors and infusion pumps to respiratory aids and surgical instruments—are among the most stringently regulated product categories in international trade. Exporting such devices from China requires establishing conformity not only to electrical safety (IEC 60601 series) and biocompatibility (ISO 10993) standards, but also to market-specific regulatory pathways: FDA 510(k) or PMA in the United States, CE under MDR 2017/745 in the European Union, MHRA registration in the United Kingdom, and TGA registration in Australia, among others. Risk classification, technical file requirements, quality management system certification, and post-market surveillance obligations all vary. The pages below compare the approval pathway, classification system, and documentation requirements for each market covered. 10 Comparison collection Index updated: 2026-06-14 [Browse all comparisons](/standard/browse) Comparison collection ## Comparisons by destination market ### Australia (RCM/AS-NZS) - [Australia (RCM/AS-NZS)](/standard/medical-device-china-to-australia) - Home/clinical medical device · View comparison ### Brazil (INMETRO) - [Brazil (INMETRO)](/standard/medical-device-china-to-brazil) - Home/clinical medical device · View comparison ### Canada (Health Canada / CSA) - [Canada (Health Canada / CSA)](/standard/medical-device-china-to-canada) - Home/clinical medical device · View comparison ### European Union (CE) - [European Union (CE)](/standard/medical-device-china-to-eu) - Home/clinical medical device · View comparison ### India (BIS/ALMM) - [India (BIS/ALMM)](/standard/medical-device-china-to-india) - Home/clinical medical device · View comparison ### Japan (PSE/JET) - [Japan (PSE/JET)](/standard/medical-device-china-to-japan) - Home/clinical medical device · View comparison ### Mexico (NOM / COFEPRIS) - [Mexico (NOM / COFEPRIS)](/standard/medical-device-china-to-mexico) - Home/clinical medical device · View comparison ### Saudi Arabia (SASO/SABER) - [Saudi Arabia (SASO/SABER)](/standard/medical-device-china-to-saudi) - Home/clinical medical device · View comparison ### United Kingdom (UKCA) - [United Kingdom (UKCA)](/standard/medical-device-china-to-uk) - Home/clinical medical device · View comparison ### United States (UL/FCC) - [United States (UL/FCC)](/standard/medical-device-china-to-us) - Home/clinical medical device · View comparison Browse all comparisons [Browse all comparisons](/standard/browse) **Related product pillars** [Grid-tied PV inverter](/standard/product/pv-inverter) · [Battery energy storage (BESS)](/standard/product/bess) · [EV charger](/standard/product/ev-charger) · [Industrial electric motor](/standard/product/industrial-motor) · [Sodium-ion battery storage (Na-ion)](/standard/product/na-ion-storage) · [Perovskite / tandem PV module](/standard/product/perovskite-pv) · [Water electrolyzer (green hydrogen, AEM/PEM)](/standard/product/electrolyzer) · [Data-center liquid cooling (cold plate / CDU)](/standard/product/datacenter-cooling) · [GaN fast charger / power adapter](/standard/product/gan-charger) · [Air-source heat pump](/standard/product/heat-pump) · [LED luminaire](/standard/product/led-luminaire) · [Electric bicycle (e-bike)](/standard/product/e-bike) · [Toys & children's products](/standard/product/toys) · [Cosmetics & personal care](/standard/product/cosmetics) · [Food-contact materials](/standard/product/food-contact) · [Lithium battery / power bank](/standard/product/lithium-battery) · [Refrigerator / cold appliance](/standard/product/refrigerator) · [PPE / respirator (mask)](/standard/product/ppe-respirator)