Quasi Medicine Registration
Indonesia has introduced a new regulatory category for quasi-medical products, which bridges the gap between consumer goods and medicinal products. Our quasi medicine registration service supports international manufacturers in classifying, registering, and legally marketing quasi medicine products in Indonesia in line with the latest BPOM regulatory framework.
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。.
Why Choose Our Quasi Medicine Registration?
Indonesia’s Food and Drug Authority (BPOM) has introduced stricter supervision for traditional medicines, quasi medicines, and health supplements, redefining how certain products must be classified and registered. Products that were previously classified as cosmetics or consumer goods may now be categorized as quasi-medicines, triggering new regulatory obligations.
Our service helps international manufacturers navigate this evolving framework by providing clear regulatory positioning, documentation strategy, and BPOM submission support. We reduce the risk of misclassification, enforcement action, or forced product withdrawal by ensuring your product is registered under the correct category from the start.
This service is especially critical for products with:
- Functional or preventive claims
- Pharmacological or bioactive ingredients
- Borderline positioning between cosmetics, supplements, and medicines
我们服务的范围和优势
Structured quasi-drug registration in Indonesia supports compliant market entry.
我们支持符合卫生部要求的持牌医疗器械分销商的设立和审批。.
Preparation of technical documentation, labeling review, and structured BPOM submission for quasi-drug products.
Coordination with BPOM during evaluation, clarification handling, and approval monitoring to reduce delays.
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。.
执照持有人服务
对于没有本地实体的制造商，我们作为中立的许可证持有者，确保注册的安全性和可转让性。.
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。.
别名服务
我们通过在经批准的本地结构下注册产品，无需立即设立公司，从而加快产品进入市场的速度。.
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。.
执照持有人服务
对于没有本地实体的制造商，我们作为中立的许可证持有者，确保注册的安全性和可转让性。.
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。.
别名服务
我们通过在经批准的本地结构下注册产品，无需立即设立公司，从而加快产品进入市场的速度。.
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。.
- info@productregistrationindonesia.com
- +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 is a quasi-medicine product in Indonesia?
Why did Indonesia introduce stricter rules for quasi-medicines?
Do foreign manufacturers need to register quasi-drug products before import?
What types of products are commonly classified as quasi-medicines?
How is quasi-medicine different from cosmetics or supplements?
What documents are required for quasi-medical registration?
Can BPOM reclassify my product during evaluation?
Yes. BPOM may reclassify a product if it determines that claims or ingredients fall outside the initially proposed category.
We help manage this risk through early regulatory assessment and positioning strategy.
Can Product Registration Indonesia support reformulation or claim adjustment if required?
Why should international manufacturers work with Product Registration Indonesia for quasi-medical registration?
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。.
