How to obtain international certification information for electric wheelchairs?

How to obtain international certification information for electric wheelchairs?

Obtaining international certification information for electric wheelchairs mainly involves the following steps and requirements:

1. Understand the applicable regulations and standards
Electric wheelchairs have different certification requirements in different countries and regions. In the EU, electric wheelchairs need to comply with the requirements of the Medical Device Regulation (MDR) [Regulation (EU) 2017/745] and the Machinery Directive (MD) [2006/42/EC]. In addition, the Electromagnetic Compatibility Directive (EMC Directive) [2014/30/EU] and the Low Voltage Directive (LVD) [2014/35/EU] need to be considered.

2. Conformity assessment and certification steps
Product classification and conformity path selection: Determine the classification of the electric wheelchair and select the appropriate conformity assessment path. Electric wheelchairs are generally classified as Class I medical devices, but because they involve power drives, they may need to be reviewed by a notified body
Clinical evaluation: Manufacturers need to conduct clinical evaluations to prove the safety and effectiveness of the device
Risk management: Risk management is performed in accordance with ISO 14971 to identify and reduce risks that may exist during the device life cycle
Technical document preparation: Including product description, clinical evaluation report, risk management report, manufacturing and quality control documents, etc.
Declaration of Conformity (DoC): The manufacturer needs to sign and issue a declaration of conformity stating that the electric wheelchair complies with all applicable EU regulations and standards
Notified body review: Select a notified body to review and approve the product’s technical documents, risk management, clinical evaluation, etc.

3. Specific requirements for CE certification
The CE certification of electric wheelchairs in the EU needs to follow the EN 12184 standard, which specifies the specific requirements and test methods for electric wheelchairs. The test content includes mechanical safety testing, strength and stability testing, brake system testing, and electrical safety and performance testing

4. Requirements for FDA 510K certification
In the United States, electric wheelchairs, as Class II medical devices, must pass the FDA’s 510K document review. This includes steps such as standard applicability analysis, existing document and data retrieval, market comparison and document writing

5. Obtaining an approval letter
After passing the FDA 510K certification, the electric wheelchair will receive an approval letter, which is a key document confirming product compliance

6. Other certifications
In addition to CE and FDA 510K certification, electric wheelchairs may also need to pass other international certifications, such as CB certification (International Electrotechnical Commission Electrical Product Conformity Testing Certification)

By following the above steps and requirements, manufacturers can ensure that electric wheelchairs meet the regulatory requirements of the international market, thereby legally and safely entering the target market.