Subsequent steps for selling electric wheelchairs in the United States after CE certification

Subsequent steps for selling electric wheelchairs in the United States after CE certification
With the increasing global aging, the demand for electric wheelchairs is growing. As one of the important markets in the world, the United States has strict regulatory requirements for the import and sale of electric wheelchairs. After obtaining CE certification, if you want to sell electric wheelchairs in the United States, you still need to follow a series of complex steps and processes to ensure that the product complies with the regulations of the U.S. Food and Drug Administration (FDA).

I. FDA 510(k) certification

(I) Preparation stage
Develop an application information list: According to the electric wheelchair products and FDA-related regulations and guidelines, develop a 510(k) application information list. The list should include all materials and requirements required for writing 510(k) application documents, such as drawings, specifications, raw materials, test items and test plans.
Select comparative products: Select comparative products based on the preliminary materials provided by the customer (such as instructions, product manuals, etc.) and the characteristics of the electric wheelchair. Comparative products should be similar products that have been legally sold in the U.S. market and are infinitely close to the application products.
Prepare test samples: The test samples should include the customer’s application products and selected comparative products.
Apply for DUNS number: DUNS number is the unique identification code of the company’s identity and is required when applying for FDA certification.

(II) Testing phase
Contact the testing agency: Contact a qualified testing agency to obtain a quotation, explain the testing items and testing requirements, etc.
Product testing: The laboratory tests the product, and the testing items usually include ISO 7176 system testing and biocompatibility testing, etc.

(III) Document preparation and submission
Prepare 510(k) documents: Prepare 510(k) application documents based on the test results and prepared materials, and submit the documents to the FDA.
FDA acceptance administrative review: After receiving the application documents, the FDA will conduct an administrative review.
FDA technical review: After the administrative review is passed, the FDA will conduct a technical review.

(IV) Obtain K number
Review passed: If the 510(k) application is approved, the FDA will issue a K number, indicating that the product can be sold in the US market.
Product registration/listing: After obtaining the K number, it is necessary to register/list the product in the FDA system (MDL: Medical Device Listing).

2. Facility Registration and Company Registration
Facility Registration: The company needs to register the facility (Establishment Registration) with the FDA, provide the company’s basic information, the address of the production facility, etc.
Company Registration: At the same time, the company also needs to register the company and designate the US Agent and Official Correspondent registered with the FDA.

3. Quality Management System (QMS)
Establish QMS: Manufacturers must establish a quality management system that complies with the ISO 13485 standard to ensure product consistency and compliance. This includes requirements in design and development, quality control during production, and supply chain management.
Factory Audit: The notified body may conduct a factory audit of the manufacturer’s production facilities to confirm that the production process complies with the ISO 13485 quality management system standard.

4. Post-marketing Supervision
Establish a post-marketing supervision system: According to the requirements of MDR, manufacturers need to establish a post-marketing supervision system (PMS) to continuously monitor the performance and safety of the device in the market. By collecting user feedback and reporting adverse events, ensure the continued safety of the device in actual use.
Report adverse events: If any adverse events that may affect the safety of patients or users occur during use, the manufacturer must report to the relevant notified bodies and regulatory agencies through the Vigilance System.

V. Annual Audit and Recertification
Annual Audit: Notified bodies usually conduct annual audits to confirm the manufacturer’s quality system and product compliance.
Recertification: If there are technical changes or design changes, recertification may be required.

VI. Compliance Strategy and Market Access Recommendations
Test and pre-test in advance: Manufacturers should conduct pre-tests in accredited laboratories before formally applying for certification to ensure that the electric wheelchair meets all relevant standards and reduce possible delays in the certification process.
Keep the quality management system updated: The quality management system is the key to CE certification compliance. Manufacturers should ensure that all production processes, design changes, and production process changes are included in the management of the quality system.
Maintain close communication with the notified body: Maintain good communication with the notified body throughout the certification process to ensure that the required documents and test samples are provided in a timely manner to improve certification efficiency.
Through the above steps, manufacturers can ensure that electric wheelchairs are sold in compliance with the US market, meet the strict requirements of the FDA, and provide safe and reliable products to American consumers.