water electretAs core components of medical purification systems, water electret devices (Water Electret Device) have significant technical barriers for import. According to the 2025 revised Medical Device Import Supervision Regulations, such equipment must meet dual standards ofMedical EquipmentISO 13485andquality management certificationand CE IVD in vitro diagnostic device directive
Three major risks of self-import
Mismatch between import license and equipment parameters
Comparative analysis using a $500,000 equipment import as example:
Latest regulatory requirements for hydrocharging equipment imports:
Recommended focus areas for importersCharge decay rateAccording to new regulations, medical-grade equipment decay rate must be ≤5%/year (previous standard ≤8%/year), industrial-grade equipment ≤12%/year. Professional agencies can provide pre-testing services to avoid additional costs from post-arrival technical rectification.
? 2025. All Rights Reserved. Shanghai ICP No. 2023007705-2 PSB Record: Shanghai No.31011502009912