1. What international certifications are required for wheelchair exports?
Depending on the service area, three types of certifications require special attention:
EU market: CE Certification (EN12184 Medical Equipment Standard) + ISO13485 Quality System
North American market: FDA Registration (21 CFR 890.3850) + UL Electrical Safety Certification
Asia-Pacific Markets: Japan JIS T9203 certification / Australia TGA registration + China GB/T 12996 standard
In 2023, while representing our German client, we completed the MDR new regulation upgrade ahead of schedule, enabling the product to enter the EU market three months earlier than similar products.
II. How to Design the Optimal Transportation Plan?
A comprehensive consideration of product characteristics and target markets is required: