What qualifications do electric wheelchair manufacturers need to have for export?

What qualifications do electric wheelchair manufacturers need to have for export?
As a type of medical device, the export of electric wheelchairs involves a series of qualifications and certification requirements. The following are the main qualifications that electric wheelchair manufacturers need to have when exporting:

1. Comply with the regulatory requirements of the target country
US FDA certification
Electric wheelchairs are classified as Class II medical devices in the United States and need to submit 510K documents to the FDA and undergo technical review by the FDA. The principle of 510K is to prove that the declared medical device is substantially equivalent to the device that has been legally marketed in the United States

EU CE certification
According to EU Regulation (EU) 2017/745, electric wheelchairs are classified as Class I medical devices. After Class I medical devices undergo relevant product testing and obtain test reports, and after compiling technical documents that meet the standards according to regulatory requirements, they can be submitted to the EU authorized representative for registration and CE certification can be completed.

UKCA certification
Electric wheelchairs and electric scooters are exported to the UK. According to the requirements of UKMDR2002 medical device regulations, they are Class I medical devices. Apply for UKCA certification as required.

Swiss certification
Electric wheelchairs and electric scooters are exported to Switzerland. According to the requirements of oMedDO medical device regulations, they are Class I medical devices. According to the requirements of Swiss representatives and Swiss registration

2. National standards and industry standards
National standards
“Electric wheelchairs” is a Chinese national standard that stipulates the terminology and model naming principles, surface requirements, assembly requirements, dimensional requirements, performance requirements, strength requirements, flame retardancy, climate, power and control system requirements, and corresponding test methods and inspection rules for electric wheelchairs.

Industry standards
“Safety Technical Specifications for Lithium-ion Batteries and Battery Packs for Electric Wheelchairs” is an industry standard, and the competent department is the Ministry of Industry and Information Technology

3. Quality management system
ISO 13485 and ISO 9001
Many electric wheelchair manufacturers will pass ISO 13485 and ISO 9001 quality management system certification to ensure that product quality and management systems meet international standards

4. Battery and charger safety standards
Lithium battery safety standards
The lithium batteries used in electric wheelchairs need to comply with the corresponding safety standards, such as GB/T 36676-2018 “Safety requirements and test methods for lithium-ion batteries and battery packs for electric wheelchairs”

5. Product testing and performance evaluation
Performance testing
Electric wheelchairs need to be tested for performance according to international standards such as the ISO 7176 series to ensure their safety and reliability
Biological testing
If it is an electric wheelchair, biological testing is also required to ensure that the material is harmless to the human body
Safety, EMC and software verification tests
Electric wheelchairs also need to complete safety, EMC and software verification tests to ensure the electrical safety and electromagnetic compatibility of the product

6. Export documents and compliance declaration
EU authorized representative
Exporting to the EU requires a compliant EU authorized representative to assist manufacturers in quickly and accurately solving various problems
Declaration of conformity
The manufacturer needs to issue a declaration of conformity to prove that the product complies with all applicable regulatory requirements

7. Other requirements
Packaging, labeling, instructions
The packaging, labeling, instructions, etc. of the product need to comply with the regulatory requirements of the target market
SRN and UDI application
Under the MDR requirements, wheelchairs exported as medical devices must complete the application of SRN and UDI and enter them into the EUDAMED database

In summary, electric wheelchair manufacturers need to follow a series of qualification and certification requirements when exporting products to ensure that the products can enter the target market smoothly. These requirements not only involve the safety and effectiveness of the product, but also include quality management systems, battery safety standards, product testing and performance evaluation and other aspects. Compliance with these regulations is the key to ensuring that electric wheelchair manufacturers can successfully compete in the global market.