Health Supplement Registration in Indonesia
Many supplement brands run into trouble simply because their product gets misclassified at the start. PRI manages your health supplement registration from dossier preparation through BPOM approval, so your product is positioned correctly from day one.
Health Supplement BPOM Registration
We handle dossier preparation, classification review, label compliance, and the full BPOM submission and evaluation process for your health supplement product.
Health Supplement Business Permit
We support Good Distribution Practice (CDOB) verification, including temperature mapping requirements set by BPOM for imported and locally manufactured supplement products.
License Holder / Local Authorised Representative
For brands without a local entity, we can act as license holder or Local Authorised Representative to fulfil BPOM's in-country representation requirement alongside your registration.
Why Pharmaceutical Registration in Indonesia Is Particularly Challenging for Foreign Manufacturers
Most delays and rejections trace back to a handful of recurring issues. Catching them early saves both time and budget.
01
Confusion over whether a product is a supplement or a medicine
Many brands assume their product will be evaluated the same way a medicine is, or vice versa. In reality, BPOM treats supplements and pharmaceutical products through entirely different regulatory pathways, with different documentation, timelines, and evaluation criteria. Getting this classification wrong at the start often means restarting the process later.
02
Dosage limits and health claims that are easy to breach without realising it
BPOM sets specific upper limits for vitamins and minerals in registered supplements, and prohibits claims that suggest a product can treat or prevent disease. Brands accustomed to less restrictive markets often submit labels or formulations that unintentionally cross these lines, leading to rejection or rework.
03
No local entity to hold the registration
BPOM requires every supplement registration to be held by a licensed entity based in Indonesia. Foreign brands without a local company need a structure in place before submission can even begin, which catches many manufacturers off guard partway through planning their market entry.
シームレスなコンプライアンスサポート
エンドツーエンドのサービス
当社は、ライセンスから製品登録までの規制の全過程を管理します。.
規制に関する専門知識
当社のチームは、深い知識と経験を組み合わせて、複雑な規制環境に対応します。.
スピードと効率
当社の実績ある戦略により、インドネシア市場における登録および承認のプロセスが加速されます。.
カスタマイズされたサポート
スムーズで安心できる旅を実現するために、個別のガイダンスと専用のサポートを提供します。.
End-to-End Health Supplement Registration Support in Indonesia
Health supplement registration in Indonesia is regulated by BPOM under Regulation No. 17/2022 and related technical guidelines, which govern how a food supplement product is classified, evaluated, and approved before it can legally enter the Indonesian market. Every product, from vitamins and minerals to herbal extracts marketed as supplements, must go through a structured registration pathway before distribution can begin.
PRI provides dietary supplement registration support that covers the full pathway, starting with a classification review to confirm your product is positioned correctly under BPOM’s framework. We then prepare your registration dossier, including formulation data, stability documentation, and labeling aligned to Indonesian requirements, before managing the full bpom health supplement registration submission and evaluation process on your behalf.
For brands that do not yet have a legal entity in Indonesia, we can also serve as license holder, fulfilling the in-country representation that BPOM requires alongside your registration. This sits alongside our core registration work rather than replacing it, giving you a single point of contact for both the regulatory and structural requirements of entering the market.
市場参入支援
Flexible market entry options supporting food supplement registration for international manufacturers entering Indonesia.
Initial Consultation
Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.
販売代理店の選択
当社は、規制および商業上の要件に準拠した適格な現地販売業者の特定と評価をお手伝いします。.
Export/Import Assistance
We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.
会社設立サポート
現地に拠点を設立する準備ができたら、インドネシアでの法令遵守を遵守した会社設立をお手伝いします。.
Initial Consultation
Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.
販売代理店の選択
当社は、規制および商業上の要件に準拠した適格な現地販売業者の特定と評価をお手伝いします。.
Export/Import Assistance
We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.
会社設立サポート
現地に拠点を設立する準備ができたら、インドネシアでの法令遵守を遵守した会社設立をお手伝いします。.
お問い合わせフォーム
弊社のチームは、お客様のビジネスニーズについてご相談に応じ、ご質問にもお答えいたします。お問い合わせフォームにご記入いただければ、1営業日以内にご返信いたします。.
弊社に連絡するその他の方法。.
- [email protected]
- +6221 5086 5603
- +62813 8543 0755
- 月～金 午前9時～午後5時
よくある質問（FAQ）
What is health supplement registration in Indonesia and why does BPOM require it?
What criteria does BPOM use to classify a product as a health supplement rather than a medicine?
What documents are required for dietary supplement registration in Indonesia?
How can a foreign supplement brand register a product in Indonesia without a local company?
What health claims are allowed on supplement product labels in Indonesia?
Are there limits on vitamin and mineral dosages in registered supplements?
How long does health supplement registration in Indonesia typically take?
How long is a supplement registration valid before it needs to be renewed?
Can BPOM inspect manufacturing facilities for foreign supplement brands?
What compliance obligations apply after a supplement product is approved?
許可された成分と効力に関する決定版ガイド
インドネシアの医療機器メーカー向けの新しいハラール認証規則について、簡潔かつ実践的な概要を解説します。2026年までにコンプライアンスを維持し、円滑な市場参入を実現するための、主要な期限、関係当局、そして段階的な手順をご紹介します。.
戦略的リーダーシップ
フセイン・H・マシュア博士（医学博士）
最高執行責任者（COO）であるフセイン・H・マシュア博士（医学博士）は、インドネシアの最も複雑な規制分野における製品登録およびライセンス取得において、10年以上にわたる献身的な実務経験を有しています。彼の戦略的な監督の下、当社の業務手順と顧客サービスは、実証済みの効率的なプロセスに基づいて構築されています。コンプライアンスとオペレーションの両方に精通した専門家リーダーならではの自信と明確さを持って、お客様の旅を始めましょう。.
