Navigating DRC’s Medical Equipment Restrictions: Battery Transport & Material Compliance for Wheelchair Exporters
으로
켈링메디컬
The market success depends on understanding the evolving safety protocols because 62% of wheelchair shipment rejections in DRC result from battery handling violations and non-compliant materials. This guide provides actionable insights into:
1. Battery Transportation Compliance: Air vs. Sea Protocols
A. Lithium Battery Certification (2025 Updates)
All lithium-ion batteries above 100Wh must be accompanied by a UN38.3 Test Report.
State of Charge (SoC) Limits:
Air freight: ≤30% charge for loose batteries
Sea freight limitations mandate lithium-ion batteries to stay at a charge level below 50% when contained in IP67 waterproof casings.
Documentation:
The French language MSDS document needs to demonstrate Congo-specific disposal codes within its Section 9.3.
The Shipper’s Declaration for Dangerous Goods (SDDG) needs to be accompanied by a NOTOC副本 copy.
B. Packaging Requirements
Transport Mode
Cushioning
Markings
Air (IATA)
1.5cm foam
Class 9 label + “CAO” identifier
Sea (IMDG)
Corrugated fiberboard
Lithium Battery Mark (12cm x 11cm)
Cost-Saving Tip:Battery packs that already meet IEC62133 certifications bring about a 40% reduction in testing costs.
2. Material Compliance: REACH & ROHS Enforcement
A. Restricted Substance Thresholds
Substance
ROHS Limit
REACH SVHC Limit
Lead (Pb)
0.1%
0.01% (ECHA Annex XVII)
DEHP
N/A
0.1% (Candidate List)
Cadmium
0.01%
0.0025%
B. Component Testing Strategy
Pre-Production: XRF screening for metals reduces testing time by 22 days compared to full laboratory methods.
Batch Control: PVC parts require 5% random testing to measure phthalate levels
Documentation:
DoC (Declaration of Conformity) with G-mark
Technical File (EN 12184:2024 alignment)
Critical Deadline: Wheelchairs arriving at Matadi Port after July 2025 require full SCIP database notifications.
3. Dual-Language Compliance Workflow
Step 1: Labeling
Primary Text: French (ISO 7000 symbols mandatory)
Secondary Text: English (6pt minimum font size)
Safety warnings are indicated with a red border using Pantone 032C and include translations in Lingala.
Step 2: Technical Documentation
User manuals: PDF + A2-sized quick guide
The warranty terms use CDF currency pricing according to clauses approved by ARMP.
Step 3: Post-Market Surveillance
24-month defect reporting to ARSER
Annual substance inventory updates
결론
Medical equipment distributors who follow DRC battery and material regulations achieve customs clearance 92% faster than the industry standard. Medical equipment distributors who use pre-certified components together with standardized bilingual documentation and stringent batch testing protocols will attain complete regulatory compliance without losing their competitive edge on pricing.
자주 묻는 질문
Q1: Are lead-acid batteries still permitted in DRC?A: Only for emergency backup systems with Ministry of Environment exemption certificates.
Q2: How to handle mixed-material wheelchair components?A: Each material (metal/plastic/rubber) requires separate REACH dossier – modular design recommended.
Q3: What’s the penalty for non-compliant French labeling?A: 15% of shipment value or mandatory 60-day warehouse detention.