R&G Bio Medical Device Manufacturing Co., Ltd. operates its quality management system in accordance with ISO 13485:2016. This page explains how customers and partners can report a product quality issue and how we handle each complaint from receipt to closure.

1. Scope

This process applies to quality complaints concerning any product manufactured and supplied by R&G Bio, including tattoo needle cartridges, PMU cartridges, syringes, hypodermic needles, needle-free injector components, and related sterile disposables. Examples include: damaged or deformed packaging, compromised sterile barrier, needle defects (bent, blocked, or unsealed), incorrect labeling, or performance that does not match agreed specifications.

2. How to Submit a Complaint

Submit quality complaints by email to [email protected] or via WhatsApp at +86 18057404072, including:

  • Your company name, contact person, and order / invoice number
  • Product name, specification, and affected quantity
  • Production batch / lot number and expiry date (printed on each unit’s packaging)
  • Clear photos or video of the issue, plus packaging labels where possible
  • A brief description of the issue and when it was discovered

Batch traceability: every sterile unit we ship carries its production batch, manufacture date, and expiry date. Keeping this information enables us to investigate within hours rather than weeks.

3. What Happens Next

  • Acknowledgment (within 2 business days): we confirm receipt and assign a complaint reference number.
  • Investigation: our quality team reviews retained samples and production records for the reported batch, and may request return of affected units for physical inspection.
  • Containment: where a batch-level issue is suspected, related inventory is placed on hold pending the investigation outcome.
  • Corrective / Preventive Action (CAPA): confirmed root causes are addressed through our CAPA system under ISO 13485, including process or inspection changes where needed.
  • Closure and feedback: you receive the investigation conclusion and the agreed resolution (replacement, credit note, or explanation) in writing.

4. Timelines

Initial acknowledgment is provided within 2 business days. A preliminary investigation result is normally available within 10 business days of receiving complete information (including samples where requested); complex investigations are kept open with status updates until closed.

5. Adverse Events and Field Safety

Our products are supplied to professional distributors and healthcare-related businesses. If a product you received from us is associated with a patient or user safety incident in your market, notify us immediately at [email protected] so we can support any required reporting to the relevant regulatory authority in accordance with applicable vigilance requirements.

6. Records

All complaints, investigation records, and CAPA outcomes are retained as part of our quality records in accordance with our ISO 13485 quality management system and applicable regulatory retention periods.

Contact

R&G Bio Medical Device Manufacturing Co., Ltd.
No. 703, Xincheng Avenue, Zengcheng District, Guangzhou City, Guangdong Province, China
Quality complaints: [email protected]
Phone / WhatsApp: +86 18057404072

Last updated: September 18, 2026