Indonesia

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.

Cisema offers regulatory insight and market access strategy for medical devices in Thailand, Indonesia, and the Philippines.

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

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

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