Навигация по ограничениям на медицинское оборудование в DRC: Транспортировка батарей и соблюдение требований к материалам для экспортеров инвалидных колясок

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

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

B. Component Testing Strategy

1. Pre-Production: XRF screening for metals reduces testing time by 22 days compared to full laboratory methods.

2. Batch Control: PVC parts require 5% random testing to measure phthalate levels

3. 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

Заключение

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.

ЧАСТО ЗАДАВАЕМЫЕ ВОПРОСЫ

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.

Get DRC-Compliant Wheelchair Solutions Today 📩 Электронная почта: inquiry@shkeling.com 📲 WhatsApp: +86 182 2182 2482 🔍 Certified Products: Keling Medical Wheelchairs

Ask about our pre-certified battery packs & REACH-compliant component kits!