印度尼西亚医疗器械注册
From device classification to MoH approval, we manage every step of your Indonesian market entry. Our team handles the documentation, the regulatory submissions, and the in-country representation — so your product reaches market without delays.
医疗器械分销许可证 (IDAK)
We manage the full IDAK application process, ensuring your local distributor holds a valid distribution license under Ministry of Health requirements before product distribution begins.
良好分销规范证书（CDAKB）
We align your quality systems, SOPs, and facility documentation to meet CDAKB standards — a mandatory prerequisite for medical device distribution in Indonesia.
向卫生部注册医疗器械
We handle product classification, technical dossier preparation, and end-to-end submission for all device risk classes through the Ministry of Health's Regalkes system.
Local Authorised Representative (LAR)
We act as your official in-country representative with the Ministry of Health — giving your products a compliant registration structure that stays independent from your distribution arrangements.
Why Medical Device Registration in Indonesia
Stalls Before It Starts
Most delays in Indonesian medical device registration come from the same three sources.
Understanding them upfront is the first step toward a faster, more predictable approval process.
01
Device classification does not map to CE or FDA risk classes
The Ministry of Health uses a four-class risk framework (Class A to D) that does not directly correspond to CE marking categories or FDA clearance pathways. Wrong classification means the wrong documentation — and rejections that set your timeline back by months.
02
Indonesia requires documentation your existing regulatory files do not cover
An Indonesian MoH dossier goes beyond a CE technical file or 510(k). Specific labeling requirements, Bahasa Indonesia translations, local quality system alignment, and IDAK prerequisites are mandatory — and missing any one of them is enough to trigger a clarification request or rejection.
03
Mandatory local representation can lock you into a single distributor
Indonesian regulations require product registrations to be held by a licensed local entity. Without a neutral licence holder structure, your product approval becomes tied to a single distributor — making it difficult to change commercial partners without losing your registration.
无缝合规支持
端到端服务
我们负责从许可证申请到产品注册的整个监管流程。.
监管专业知识
我们的团队拥有深厚的知识和丰富的经验，能够应对复杂的监管环境。.
速度与效率
我们行之有效的策略可以加快印尼市场的注册和审批流程。.
定制支持
提供个性化指导和专属支持，确保旅程顺畅无忧。.
End-to-End Medical Device Registration Support in Indonesia
Medical device registration in Indonesia is governed by the Ministry of Health through the Regalkes system and covers three mandatory requirements: a distribution license (IDAK), Good Distribution Practice compliance (CDAKB), and product registration approval (AKL/NIE). Every device — from Class A consumables to Class D implantables and IVDs — must be registered under a licensed local entity before it can be legally imported, marketed, or distributed in the Indonesian market.
Product Registration Indonesia provides a single, coordinated service framework that covers every step of the registration pathway. We begin with device classification and documentation scoping under MoH guidelines, align your technical files to Indonesian submission standards, and manage the full submission and follow-up process directly with the Ministry. For manufacturers that require in-country representation, we serve as your Local Authorised Representative — holding registrations on your behalf and maintaining your market access independently of any single distributor arrangement.
市场准入支持
为进入印度尼西亚市场的国际制造商提供灵活的市场准入方案，支持体外诊断和医疗产品注册。.
Initial Consultation
Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.
分销商选择
我们协助识别和评估符合监管和商业要求的合格本地分销商。.
Export/Import Assistance
We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.
公司注册支持
当您准备在当地设立分支机构时，我们将协助您在印度尼西亚合法注册公司。.
Initial Consultation
Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.
分销商选择
我们协助识别和评估符合监管和商业要求的合格本地分销商。.
Export/Import Assistance
We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.
公司注册支持
当您准备在当地设立分支机构时，我们将协助您在印度尼西亚合法注册公司。.
咨询表
我们的团队随时准备与您探讨您的业务需求，并解答您的任何疑问。请填写我们的咨询表格，我们将在一个工作日内回复。.
其他联系我们的方式。.
- [email protected]
- +6221 5086 5603
- +62813 8543 0755
- 周一至周五 上午9:00 - 下午5:00
常见问题 (FAQ)
What are the requirements for medical device registration in Indonesia?
How are medical devices classified under Indonesian MoH regulations?
What is the difference between IDAK and CDAKB in Indonesia?
Can a foreign manufacturer register a medical device in Indonesia without a local company?
What is a Local Authorised Representative (LAR) for medical devices in Indonesia?
What documents are required for medical device registration in Indonesia?
What does medical device labeling in Indonesia require?
How does IVD registration in Indonesia differ from standard medical device registration?
How long does medical device registration approval take in Indonesia?
What happens after a medical device is registered in Indonesia?
具有战略领导力
Hussein H. Mashhour 博士，医学博士
作为我们的首席运营官 (COO)，侯赛因·H·马什胡尔医学博士 (Dr. Hussein H. Mashhour, MD) 在印尼最复杂的监管领域拥有十余年的产品注册和许可实战经验。他的战略指导确保我们的运营流程和客户服务建立在成熟高效的流程之上。选择一位在合规和运营方面都经验丰富的领导者，开启您的旅程，您将获得只有他才能提供的信心和清晰的指导。.
