Ningbo Baichen Medical Devices Co., Ltd. held its September Summary Meeting: Record-breaking Performance and Further Upgraded Strategic Layout

On October 17, 2025, Baichen held its monthly summary meeting at its Ningbo headquarters.(The following is a brief summary of the important contents of the meeting)

Highlights: Record-breaking Performance, Outstanding Performance in Overseas Markets.

Data released at the meeting showed that the company's sales in September increased by 30% year-on-year, with significant growth in the European market and continued stable growth in the Middle East and Southeast Asia. Within the core electric wheelchair product line, carbon fiber series sales exceeded expectations, and orders for aluminum alloy products exceeded three times the same period last year. Cross-border e-commerce channels performed particularly well.

Qualification Growth: ISO 13458 Quality System Certification in 2025

The foreign trade department reported on the latest certification progress at the meeting. The 2025 13485 quality system audit was successfully passed.

A Passport to Global Market Access: Medical device regulations in many countries and regions around the world (such as the EU, Canada, Australia, and Japan) recognize or directly adopt ISO 13485 as a quality management system requirement. Certification is a prerequisite for product marketing in these markets. Complying with Chinese regulations: In China, the ISO 13485 standard serves as a key reference for the Medical Device Supervision and Administration Regulations and its supporting regulations. Certification is a key support for applications for medical device registration certificates and production/operation licenses, significantly improving the efficiency and approval rate of drug regulatory authorities.

Streamlining the EU CE certification process: For EU market entry, ISO 13485 provides core evidence of compliance with the quality management system requirements of the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Device Regulation). Certification significantly simplifies the CE technical file review process.

Adoption of the new ISO 13458 strengthens Baichen's market competitiveness and brand reputation.

Strong trust: ISO 13485 certification is the most powerful demonstration to customers, regulators, and partners of a company's ability to consistently provide safe and effective medical devices.

Winning clients and bidding advantages: An increasing number of hospitals, purchasers, and large-scale projects require ISO 13485 certification as a supplier qualification. Possessing this certification provides significant bidding qualifications and a competitive advantage.

Enhanced brand image: It represents the company's commitment and professionalism in quality management and is a crucial component of its brand value and reputation.

Baichen Medical will continue to uphold the philosophy of "innovation-driven development" to provide higher-quality mobile solutions to users around the world.

 Ningbo Baichen medical Devices Co.,LTD.,

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