Starting from November 1, 2026, the revised Good Manufacturing Practice for Medical Devices of China officially takes effect. Material balance has become a mandatory general requirement covering all categories of medical devices under this China local regulation. For medical device manufacturers, lot control and data traceability of packaging materials are critical to passing regulatory audits on material balance calculation. This article outlines three key compliance points.
Material balance has been moved from the appendix into the main text of the revised GMP. It requires manufacturers to document material balance calculation within batch records for every lot or unit produced.
Material balance compares the sum of actual output / consumption plus collected waste against the theoretical quantity, within an approved permissible deviation.
Printed packaging materials are classified as high-risk materials and require lot-by-lot material balance calculation. If the result falls outside approved limits, the batch shall be quarantined immediately and a deviation investigation launched. The batch cannot be released until risks are fully resolved and root causes confirmed.
The regulation does not make MES deployment compulsory. However, companies using digital systems must ensure electronic records are authentic, accurate, complete, timely and traceable, with user permission control, audit trails and data backup. Many Chinese medical device manufacturers are implementing MES for automatic material data capture and electronic batch records.
Reliable digital traceability depends on standardized incoming material data. As part of material balance calculation, packaging materials require clear lot marking, accurate delivery quantities and accessible test certificates to support trustworthy traceability inside customers’ systems.
| Test Item | Martin Internal Control | General Standard |
|---|---|---|
| Initial bioburden | ≤30 CFU/100cm² | ≤100 CFU/100cm² |
| Particle contamination | ≤50 /100cm² | ≤90 /100cm² |
| Seal integrity (dye penetration) | No leakage after >30 seconds static hold | Observation window: 5–30 seconds |
Tighter internal specifications reduce quality variation, helping customers rule out packaging as a contributing factor and focus investigation on production processes.
Martin Medical Packaging operates under ISO 13485. Our sterile barrier systems are validated to ISO 11607 and manufactured in a Class 10,000 (ISO Class 7) cleanroom. Full lot traceability runs from raw material receiving to finished goods dispatch.
Every shipment of thermoformed trays, lidding and sterile pouches carries clear lot identification, reconciled delivery quantities and retrievable inspection records, delivering standardized data for customers to meet China’s material balance requirements and integrate with their digital quality systems.
For lot traceability statements or summaries of our internal control standards, please contact your sales engineer or call +86-756-8988 909.
