Repeat Medical Device Procurement from China: Control What Changes

Create the approved baseline

Keep the signed specification, model, accessories, packaging, labeling, document versions, approved sample and commercial terms in one SKU record.

Ask what changed

• Components, materials or software
• Manufacturing site or subcontractor
• Packaging, labeling or instructions
• Registration or certificate status
• MOQ, lead time or shipping method

Use batch-level evidence

Define which production, inspection, traceability or release records must accompany each order. The exact evidence depends on the device, contract and destination-market responsibilities.

Plan replenishment backwards

Combine production time, inspection, document preparation, export handling, transit, customs and local release into the reorder point. Unit price alone does not protect availability.