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| Country | Manufacturing Capacity (tons/year) | Regulatory Compliance | Quality Certification | Lead Time (days) |
|---|---|---|---|---|
| USA | 5000 | FDA Approved | ISO 9001 | 30 |
| Germany | 3000 | CE Marked | ISO 13485 | 25 |
| China | 8000 | NMPA Approved | ISO 9001, ISO 14001 | 20 |
| India | 2000 | DCGI Approved | ISO 9001 | 35 |
| Japan | 4000 | MHLW Approved | JIS Mark | 15 |