1671 Have consulted
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
关于熊猫出海
Southeast Asia business inspection
In order to help customers explore markets, seek business opportunities, and understand the economic situation, Panda Overseas tailors on-site inspection plans for companies that intend to carry out investment activities overseas, and provides comprehensive, refined, and customized inspection services to allow companies to conduct on-site inspections for customers. Conduct in-depth investigations and research on markets, suppliers, competitors, etc. to help companies make correct investment decisions. Service area:None
Overseas factory site selection|factory construction
Site selection is an important step before an enterprise actually puts into operation. The decision-making issue of site selection usually affects the enterprise's investment income, operating costs, tax policy preferences, sales channels, enterprise competitiveness, enterprise resource utilization, and the sustainable development of the enterprise, etc. Many aspects. Service area:None
BOI certificate application-Thailand
Applying for an "Investment Promotion License" from BOI is currently a favored way of investing in Thailand by Chinese-funded enterprises. Service area:Thailand
Monthly accounting and tax filing-Vietnam
Vietnam is a member of the World Trade Organization. Both domestic and foreign-funded enterprises adopt unified tax standards and implement different tax rates and exemption periods for projects in different fields. The main taxes in the current tax system are: corporate income tax, value-added tax, import and export tax, special sales tax, personal income tax, resource tax, agricultural land use tax, non-agricultural land use tax, environmental protection tax, property tax, stamp tax, and house tax. wait. Service area:Vietnam
"Compliance Management of "Going Global" Enterprises" Total 9 sections
Enterprises going overseas tax compliance Risk prevention solution
811 Learned ￥198.00
International engineering and labor tax practice sharing Total 9 sections
One Belt One Road Liang Hongxing international engineering
717 Learned ￥198.00
"Individual Income Tax Practices for Overseas Dispatched Personnel of "Going Global" Enterprises" Total 7 sections
go out Corporate overseas dispatch Personal Income Tax Practice
882 Learned ￥198.00
"Challenges and Responses to International Taxation for "Going Global" Enterprises—Cross-Border Taxation" Total 11 sections
go out corporate state tax Cross-border taxation
818 Learned ￥198.00
How to respond to tax audits in 2022? Total 8 sections
Responses tax inspection
814 Learned ￥30.00
Interpretation of tax incentives for investment in Southeast Asia Total 2 sections
Southeast Asia tax incentives Southeast Asia tax policy
788 Learned ￥30.00
Land holding restrictions for foreign-funded enterprises investing in Southeast Asia Total 1 sections
Southeast Asia Investment Overseas property purchase
898 Learned ￥30.00
2024 Southeast Asia E-commerce Market Insights Report
Free
In-depth Insight Report on the Globalization of Chinese Enterprises: Southeast Asia
Free
United Nations: World Investment Report 2024
Free
State Administration of Taxation: Tax Guidelines for “Going Global” (Revised Version 2024)
Free
In-depth Insight Report on the Globalization of Chinese Enterprises - Industry
Free
Overview of China's overseas investment in the first half of 2024
Free
China's Outward Investment and Cooperation Development Report 2023·Ministry of Commerce
Free
Overview of China’s Overseas Investment in 2023
Free