日本市场准入：需符合当地法规 + 进口许可 + 税务注册
Reference standards for this product category — verify applicability with your testing lab before export.
| Standard No. | Organization | Title | Year |
|---|---|---|---|
| ISO 15190:2020 | ISO | 医学实验室 安全要求 | 2020 |
| ISO 15189:2012 | ISO | 医学实验室 质量和能力要求 | 2012 |
| Certification | What it covers | Status |
|---|---|---|
| 当地合规认证 | 需按当地法规办理 | Required |
Complete certification list, testing checklist and official source links — cross-verified with China-side requirements.