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Service introduction
关于医疗器械产品在印尼销售的相关规定
政府法规要求外国企业不得在印度尼西亚经营医疗产品，除非有当地经销商或者成立了外商直接投资有限公司。
医疗器械产品要想在印尼进行销售，企业需要办理医疗器械分销商许可证 (IDAK)、分销医疗器械的良好规范（CDAKB），以及医疗器械分销许可证（AKD/AKL）。
印尼医疗器械产品销售需要办理的证件
1、医疗器械分销商许可证 (IDAK)
1）医疗器械分销商许可证 (IDAK) 是由印尼卫生部长颁发给分销商而已经采用适当分销方法分销医疗器械的证书。
2）要供应大量医疗器械的公司或分销商必须办IDAK 认证。目的是为了保障进口和整个印尼分销医疗器械分销链的安全、质量和功效。
3）医疗器械分销许可证的类型可分为：
辐射电子医疗器械 (Alat Kesehatan Elektromedik Radiasi)
非辐射电子医疗器械 (Alat Kesehatan Elektromedik Non Radiasi)
无菌非电子医疗器械 (Alat Kesehatan Non Elektromedik Steril)
非无菌非电子医疗器械 (Alat Kesehatan Non Elektromedik Non Steril)
体外诊断产品 IVD (Produk Diagnostik In Vitro)
4）IDAK 许可证的有效期为 5 年，还可以延期。
2、分销医疗器械的良好规范（CDAKB）
分销医疗器械的良好规范（CDAKB）是对医疗器械分销活动和质量保证的一个指南。CDAKB 的概念相当于 ISO。
医疗公司或医疗分销公司必须先办理IDAK认证、然后办理CDAKB认证，最后才可以办理 AKL/AKD 认证。
3、医疗器械分销许可AKL/AKD
无论是本地医疗器械（AKD）还是进口医疗器械（AKL），只要是在印尼进行分销的医疗器械产品都必须取得医疗器械分销许可证。
分为4个风险登记，类似国内三类医疗器械。
服务周期
一般情况下，办理IDAK 许可证需要20个工作日，办理CDAKB 证书需要3个月时间，而办理AKD/AKL根据风险等级需要6-45个工作日认证完成。
配套服务
印尼相关医疗器械销售许可的办理需要提供印尼公司章程、营业执照等相关资料，因此建议配套熊猫出海印尼公司注册服务一起进行。
熊猫出海
为您定制一站式出海解决方案
① 投资咨询——找准企业出海方向
② 商务考察——实际掌握海外情况
③ 投资报告——确定企业落地策略
④ 建厂选址——选址选对事半功倍
⑤ 园区入驻——快速落地安全投产
⑥ 尽职调查——知己知彼百战不殆
⑦ 财法税合规——风险把控行稳致远
⑧ ODI境外投资备案——资金通道安全合规
⑨ 公司注册——专业团队便捷高效
⑩ 物流服务——专属定制跨境方案
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