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
. Special attention should be paid to HS code classification during import declaration. Current classifications:
Medical-grade water electret equipment: 9018.90.6000 (5% tariff + 13% VAT)
Three major risks of self-import
Missing technical documents
According to General Administration of Customs statistics for first half of 2025, abnormal declaration rate for self-clearance of water electret equipment reaches 38%, mainly concentrated in:
Failure to provide original manufacturers Material Safety Data Sheet (MSDS)
Expired version of Electromagnetic Compatibility report (EMC)
Logistics configuration errors
Equipment damage due to non-use of anti-static packaging
Temperature deviation exceeding ±2℃ in temperature-controlled containers
Compliance risks
Failure to complete medical device registration (especially involving FDA 510(k) certification)
Full Process Breakdown of Professional Agency Services
Mismatch between import license and equipment parameters
Standard operating procedures for quality agency services include six key phases:
Equipment parameter compliance pre-review
Preliminary technical assessment (3-5 working days)
Matching applicable tariff preferential policies
Document preparation phase (7-10 working days)
Agency service for medical device import filing certificate
International transportation management (depending on transportation mode)
Professional anti-vibration packaging solution design
Real-time temperature and humidity monitoring system configuration
Cost comparison: Self-operation VS Professional agency
Comparative analysis using a $500,000 equipment import as example:
Time Cost
Self-operation: Average processing time 68 days
Professional agency: Controlled cycle within 45 days
Cost of funds
Port demurrage difference: Self-operation averages $12,000
Tariff benefits: Professional agencies can save 3-5% comprehensive tax rate
Hidden Costs
Technical rectification costs reduced by 80%
Insurance claim success rate increased to 95%
Key policy change highlights for 2025
Latest regulatory requirements for hydrocharging equipment imports:
Import license validity period shortened from 3 years to 2 years
New customs inspection items addedElectret charge density testingProject
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.