Medical device packaging solutions

📋 Industry Overview

The core of medical device packaging lies in compliance and safety. From the mandatory requirements for UDI labeling to the selection of suitable sterilization methods, every step is strictly governed by the YY/T 0313 standard and the ISO 13485 quality system. Lexiang Packaging provides medical device enterprises with end-to-end services ranging from customized packaging boxes to UDI label printing, supporting EO sterilization/gamma radiation sterilization-compatible packaging, piece-by-piece variable data printing, and small-batch production with a minimum order of 50 sets. This helps enterprises reduce inventory risks while maintaining compliance and accelerate the launch of new products.

💡 LeXiang Solutions

⚠️ What packaging challenges does your industry face?

• ❌ Sterilization Method Incompatible with Packaging Materials Packaging design team and sterilization process team work separately, lacking collaborative verification processes. Sterilization validation (IQ/OQ/PQ) typically starts only after packaging samples are completed, at which point issues discovered have already caused double waste of cost and time.；Sterilization validation failure results in scrapping of entire packaging batches, with economic losses of 50,000-200,000 RMB per batch. Sterilization method adjustments require re-registration changes, extending market launch cycle by 3-6 months.
• ❌ UDI Implementation Progress Lagging UDI involves two levels: product identifier (PI) and production identifier (PI). PI includes variable unit-level information such as batch number, serial number, and expiration date. Traditional printing methods cannot achieve different codes per unit in mass production, requiring switch to digital variable data printing.；UDI implementation delay → required by regulatory authorities to remove from shelves for rectification → affects hospital supply qualification. Some provinces have incorporated UDI into bidding evaluation items, with non-compliant items directly deducted.
• ❌ High Inventory Pressure Under Small-Batch Multi-Order Demands Offset plate-making fee is 2000-5000 RMB per design. The plate cost amortization logic determines that minimum order quantities must be large. To amortize plate costs, companies must print large quantities at once, but actual monthly consumption per product may be only 200-500 pieces, with inventory turnover days exceeding 200 days.；Packaging inventory occupies 500,000-2,000,000 RMB in capital per year. Some devices have printed packaging scrapped due to label information changes (such as registration certificate number updates), with scrap rate of 15-30%.
• ❌ Frequent Label Information Changes Causing Scrap Label system changes are driven by regulatory approval. Companies cannot predict or stock up in advance. Fixed plates for offset/flexographic printing require re-plating for each change, with a cycle of 15-30 days from approval to delivery, during which production lines may come to a standstill.；Each label change causes direct material loss of 30,000-80,000 RMB. Production line downtime loss during change period is 50,000-150,000 RMB per day.
• ❌ Incomplete Packaging Validation Documents, Failing Unannounced Inspections Packaging validation involves multiple links including material testing (breathability/seal strength/microbial barrier), sterilization validation, and transportation testing, with a validation cycle of 30-60 days. To rush market launch, companies often simplify validation processes, leaving compliance risks.；Regulatory unannounced inspection failure → production suspension and rectification → affects supply continuity to all hospitals. Serious violations may result in registration certificate suspension.

Lexiang Solution

📦 Applicable Products

❓ FAQ