{"id":16533,"date":"2025-10-15T09:44:18","date_gmt":"2025-10-15T02:44:18","guid":{"rendered":"https:\/\/investinasia.id\/blog\/?p=16533"},"modified":"2025-10-20T15:17:21","modified_gmt":"2025-10-20T08:17:21","slug":"indonesia-medical-product-registration-guide","status":"publish","type":"post","link":"https:\/\/investinasia.id\/blog\/indonesia-medical-product-registration-guide\/","title":{"rendered":"Indonesia Medical Product Registration: A Complete Guide"},"content":{"rendered":"

Registering a medical product in Indonesia demands strict compliance with dual authorities (BPOM for drugs, Kemenkes for devices), precise dossier preparation, and ongoing post-market vigilance. With proper planning, you can navigate classification, evaluation, and licensing within reasonable timelines.<\/p>\n

Regulatory Landscape & Business Foundation<\/h2>\n

Indonesia\u2019s regulatory architecture separates drugs and supplements under BPOM<\/a> from medical devices \/ household health supplies (PKRT) under the Ministry of Health \/ Kemenkes. A successful registration strategy first ensures you choose the correct path.<\/p>\n

Before dossier submission, you must establish legal presence or representation in Indonesia. Foreign firms often set up a PT PMA<\/a> entity or appoint a Local Authorized Representative (LAR). Domestic entities must register via OSS, obtain NIB<\/a>, and secure appropriate business licenses.<\/p>\n

Pharmaceutical Registration (Drug Products)<\/h2>\n
\"Indonesia
Indonesia Medical Product Registration: A Complete Guide (pexels.com)<\/figcaption><\/figure>\n

Classification & Applicant Criteria<\/h3>\n

Pharmaceuticals fall into categories such as prescription (G), OTC, or narcotics. For registration, BPOM defines categories 1\u20137 (new drugs, generics, variations, renewals).
\nLocal manufacturers must hold a valid pharmaceutical industry license and CPOB \/ GMP certification. Imported drugs require a LoA, GMP from origin country, and authorization via a domestic entity.<\/p>\n

Dossier & Evaluation Timeline<\/h3>\n

Your dossier is divided into administrative, quality, non-clinical, and clinical modules. For imported drugs, notarized LoA and certificate of free sale (or equivalent) are critical.
\nUnder Regulation No. 23 of 2025, evaluation times have been adjusted: e.g. generic emergency use may be reviewed in 5 working days, new drug standard evaluation ~300 working days. Expect the whole process to take 12\u201324 months depending on complexity.<\/p>\n

Import Permit & Renewal<\/h3>\n

Each import requires an SKI (Import Certificate) tied to one shipment. Licenses (Izin Edar) typically last 5 years and require renewal well in advance.<\/p>\n

Also read; 13 Leading Companies in the Health Sector in Indonesia<\/a><\/strong><\/p>\n

Medical Device & PKRT Registration<\/h2>\n

Risk Classification & Requirements<\/h3>\n

Devices are categorized into Classes A, B, C, D based on invasiveness, duration of contact, risk. Higher classes need more rigorous evidence (clinical data, biocompatibility tests).
\nForeign manufacturers need to appoint a single LAR and the LAR must have IDAK, and within a year, CDAKB certification.<\/p>\n

Submission Format & Process<\/h3>\n

You must use the ASEAN CSDT dossier template and submit via Regalkes \/ ASPAK. The pre-submission step classifies your device and generates a PNBP (fee) notice.
\nProcessing times range by class (e.g. Class A ~15 days, Class D ~45 days), assuming complete dossier submission.<\/p>\n

Post Market & Renewal<\/h3>\n

You must maintain PMS: adverse event reporting via e-watch, regular product testing, facility audits, and biannual reporting. Licenses must be renewed (often 2\u20135 years validity).<\/p>\n

For PKRT products, classification is by risk (Class 1\u20133). The submission is simpler than medical devices but still requires safety\/efficacy data, labeling in Bahasa Indonesia, and dossier to the Ministry of Health.<\/p>\n

Also read: Pharma and Healthcare Investment Incentives in Indonesia: Market Outlook, Tax Holidays, and KEK MedTech Advantage<\/a><\/strong><\/p>\n

Strategic Tips & Common Pitfalls<\/h2>\n
\"Indonesia
Indonesia Medical Product Registration: A Complete Guide (pexels.com)<\/figcaption><\/figure>\n