MoH Indonesia Medical Device Registration
Get comprehensive support for medical device registration in Indonesia through Cisema’s local office in Jakarta. From feasibility assessments and risk analysis to regulatory strategy, documentation, and quality control inspections, we act as your local medical device license holder and registration partner, helping foreign manufacturers meet Indonesian regulatory requirements and achieve market entry.
Whether registering a single product or managing multiple registrations, Cisema supports every stage of the Indonesia medical device registration process, from device description and classification to dossier preparation and submission under the ASEAN Medical Device Directive. We help manufacturers navigate medical device registration requirements, ensure regulatory compliance, and integrate Indonesia into a broader ASEAN market access plan.
Indonesia Healthcare Market Overview
With more than 287 million people, Indonesia is one of Southeast Asia’s largest healthcare markets. Urbanization, rising demand for modern diagnostics and treatments, and continued investment in healthcare infrastructure are driving market growth. More than 3,000 hospitals and 10,000 public health centers create a substantial market for companies aiming to register medical devices and in vitro diagnostics (IVDs).
Medical device registration in Indonesia is governed by the Ministry of Health through the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes), with digital submissions processed via the e-regalkes system. All medical devices, from low-risk Class A to high-risk Class D, require a valid medical device distribution license (Izin Edar) before they can be marketed in Indonesia.
Cisema's Indonesia Medical Device & IVD Registration Services
Cisema provides regulatory consulting tailored to the Ministry of Health requirements and the ASEAN Common Submission Dossier Template (CSDT) framework. We support foreign clients in achieving early compliance, registration success, and efficient route-to-market execution.
Regulatory Strategy & Classification
Documentation Readiness & Feasibility Review
Regulatory Intelligence & Local Adaptation
Strategic ASEAN Integration
Ongoing Regulatory Intelligence & Alerts
Medical Device Change Management & Post-Market Surveillance Services
Cisema supports medical device manufacturers with regulatory change management and post-market surveillance in Indonesia, helping maintain product registration and compliance throughout the product lifecycle.
Device Change & PMS Impact Assessment
Regulatory Change & Compliance Support
Regulatory Intelligence & Impact Assessment
Post-Market Safety & Vigilance
Quality Control Inspection Services for Medical Devices & IVDs in Indonesia
Cisema’s quality control services verify that your products comply with Indonesian and international IVD and medical device regulations, including CE, FDA, and ISO 13485 standards. Our support includes:
Incoming Goods Inspections
In-Process Monitoring
Final Product Inspection
Custom Audits
Why Work with Cisema?
Local expertise with global reach
Our bilingual teams bridge international quality standards with local regulations
Proven track record
Over 20 years supporting market approvals and compliance in China and Asia Pacific
End-to-end solutions
From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle
Industry breadth
Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods
Cisema's Indonesia Office
PT CISEMA INDONESIA GROUP
HQ Menara Caraka, 9th Fl Unit 929 Jl. Mega Kuningan Barat Blok E.4.7. 1 Mega Kuningan Area Kelurahan Kuningan Timur, Kecamatan Setiabudi Kota Administrasi Jakarta Selatan, RT.5/RW.2, Kuningan, Kuningan Tim., Kecamatan Setiabudi, Jakarta, Daerah Khusus Ibukota Jakarta 12950, Indonesia
