Indonesia
7 articles
Indonesia's Device Registry: 78K Registrations, 76% Imported, Expiry Cliff
Analysis of Indonesia's Kemenkes device registry reveals 75.8% of registrations are imports (AKL), China supplies 36.5% of imported devices, and 17.2% of all registrations expire in 2026.
Indonesia Medical Device Registration Cost: LAR Pricing Models and Cash Flow
Compare Indonesia LAR pricing models for medical device registration, including hourly, annual, and flat-fee structures, AKD/AKL cash flow, and importation fee mechanics.
ASEAN Device Entry: Distributor Qualification and Test Report Reuse Matrix
Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.
Indonesia AKD Registration: Halal and CDAKB Requirements Explained
Clarifies when Indonesian medical devices need BPJPH Halal certification, how AKD registration works, and why CDAKB obligations usually sit with local distributors.
Indonesia e-Katalog Medical Device Procurement: JKN, TKDN, Market Access
Guide to Indonesia's e-Katalog procurement system for medical devices, including MoH catalogs, JKN reimbursement, TKDN local content rules, registration, and distributor requirements.
Indonesia Medical Device Registration: The Complete Guide for Foreign Manufacturers
Guide to registering medical devices in Indonesia, covering BPOM/MoH classification, CSDT dossiers, Regalkes submissions, local representatives, Halal deadlines, and market entry.
Medical Device Registration in Southeast Asia: ASEAN Harmonization & Country Guide
Navigate medical device registration across ASEAN — the AMDD framework, country-by-country requirements for Indonesia, Thailand, Malaysia, Philippines, Vietnam, and Singapore.