Indonesia

Learn Indonesia's cosmetic PIF requirements, ingredient compliance rules, and common pitfalls to avoid.

Discover the documents required for Indonesia medical device and IVD registration, including dossier requirements, legalization, submission and common FAQs.

Understand Indonesia halal certification requirements for health supplements, including BPJPH registration, ingredient review, and halal labeling obligations.

Learn how Indonesia halal cosmetic certification works, including BPJPH requirements, halal labeling rules, ingredient compliance, and registration obligations.

Learn which products are covered by Indonesia's halal framework, the labeling and manufacturing obligations, and phased compliance timelines.

Learn how to register medical devices in Indonesia, including Authorized Representative rules, classification, dossiers, timelines, and fees.

Learn about license validity and renewal rules for medical devices in Southeast Asia.

Explore fast-track medical device registration in Southeast Asia, cut timelines by 6–12 months, and accelerate market entry with Cisema.

Learn how the medical device markets of Thailand, Indonesia, and the Philippines differ in terms of regulation, healthcare growth, and commercial opportunity.

Enter Southeast Asia’s dental market with a clear strategy: navigate regulatory complexity, sequence market entry, and retain control of registrations to scale efficiently.

Learn about Cisema’s redesigned website with faster performance, clearer navigation and expanded Asia Pacific coverage.

Indonesia’s BPOM has strengthened clinical trial approval procedures and introduced detailed requirements for cosmetic clinical trials.

Indonesia removes IDAK renewals, mandates SDAK and IPAK transitions, and shortens correction timelines under risk-based licensing.

New policy streamlines COVID-19 Antigen RDT registration and renewal applications.

Applicable for new registrations, renewals, and variations, the Standardized Medical Device Specification Template improves data consistency and regulatory review efficiency.

Indonesia’s Ministry of Health now enforces annual internal audits for medical device distributors under PP No. 28/2025.

Indonesia has expanded retail access for selected low-risk medical devices, opening new sales channels to benefit consumers.

Indonesia revises medical device and IVD registration timelines under Permenkes 11/2025, extending approval timelines.

Indonesia’s Ministry of Health will temporarily close key medical device licensing and registration systems from December 2025 to January 2026

BPOM confirms pharmaceutical authorization, GMP oversight, and regulatory authority remain unchanged under the Indonesia–US trade agreement.

Indonesia’s BPS has updated KBLI business classification codes, impacting licensing, OSS data, and compliance for regulated sectors.