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Medical Devices → Japan

日本市场准入：需符合当地法规 + 进口许可 + 税务注册

Lead time 4-8 weeks
Cost range USD 1,000-5,000
HS code 9018
Duty rate —
VAT / tax 10%

Technical standards

Reference standards for this product category — verify applicability with your testing lab before export.

Standard No.OrganizationTitleYear
ISO 11607-1:2019 ISO 最终灭菌医疗器械包装 2019
ISO 14971:2019 ISO 医疗器械风险管理 2019
ISO 10993-1:2018 ISO 医疗器械生物学评价 第1部分：风险管理中的评价与试验 2018
ISO 11138-1:2017 ISO 医疗保健产品灭菌 生物指示物 2017
ISO 10993-11:2017 ISO 医疗器械生物学评价 第11部分：全身毒性试验 2017
ISO 10993-4:2017 ISO 医疗器械生物学评价 第4部分：血液相容性 2017
ISO 13485:2016 ISO 医疗器械质量管理体系 2016
ISO 10993-6:2016 ISO 医疗器械生物学评价 第6部分：植入后局部反应 2016

Required certifications

CertificationWhat it coversStatus
当地合规认证 需按当地法规办理 Required

Labeling requirements

Common non-compliance risks

Frequently asked

需要 日本 税号吗？
B2C 销售通常需要注册当地税号，否则无法在平台销售。
认证周期多久？
一般 4-8 周，视产品复杂度。
费用大概多少？
参考 USD 1,000-5,000，复杂产品更高。

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Full compliance report

Complete certification list, testing checklist and official source links — cross-verified with China-side requirements.

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