Quality Commitment

At Tongchen Biotechnology, we are committed to maintaining the highest standards of quality in all our products and processes. Our certifications demonstrate our dedication to excellence and compliance with international standards.

All our manufacturing processes follow strict quality control procedures, and our facilities are regularly audited to ensure compliance with international standards. We continuously invest in improving our quality management systems to better serve our customers.

Our Certifications

ISO 9001 Certificate

ISO 9001:2015

Quality Management System Certification

Certificate No: CN19/30009

Valid until: December 2026

ISO 13485 Certificate

ISO 13485:2016

Medical Devices Quality Management

Certificate No: MD19/30045

Valid until: November 2026

CE Certificate

CE Marking

European Conformity for Medical Devices

Certificate No: CE-2024-001

Valid until: March 2027

GMP Certificate

GMP Certification

Good Manufacturing Practice

Certificate No: GMP-CN-2024-001

Valid until: January 2027

FDA Registration

FDA Registration

US Food and Drug Administration

Registration No: 3012345678

Renewed annually

Environmental Certificate

ISO 14001:2015

Environmental Management System

Certificate No: EMS19/30078

Valid until: October 2026

Quality Standards & Compliance

Manufacturing Standards

  • ISO 13485:2016 Medical Devices Quality Management
  • Good Manufacturing Practice (GMP)
  • Cleanroom Class 100,000 standards
  • Traceable raw material sourcing

Testing & Validation

  • Comprehensive batch testing
  • Stability and shelf-life studies
  • Performance validation protocols
  • Third-party laboratory verification

Documentation & Records

  • Complete batch documentation
  • Quality control records retention
  • Change control procedures
  • Regulatory compliance tracking

Certificate Downloads

Download our certificates for your records and verification purposes.