Indonesia Medical Device Registration
Indonesia is home to over 277 million people and offers a fast-evolving healthcare landscape fueled by urbanization, rising demand for modern diagnostics and treatment, and increased investment in public and private healthcare infrastructure. With more than 3,000 hospitals and over 10,000 public health centers, the country presents strong growth opportunities 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 Sistem Registrasi Alat Kesehatan platform. All devices, from low risk class A to high risk class D, require a valid medical device distribution license (Izin Edar) before market entry. The requirements apply to both domestically produced and imported medical devices in Indonesia.
Cisema provides end-to-end support for Indonesia medical device registration, including feasibility evaluations, risk analysis, documentation readiness, regulatory strategy, and quality control inspections. While Cisema does not currently act as a license holder in Indonesia, we assist foreign manufacturers in preparing their registration license application before appointing a local distributor, independent license holder, or distributor license holder.
Whether targeting a single product or managing multiple registrations, Cisema’s guidance supports the entire evaluation process, from device description and classification to dossier preparation and submission under the ASEAN Medical Device Directive. Our services enable manufacturers to align with indonesian regulations, navigate regulatory process flow, and integrate Indonesia into a broader ASEAN market access plan.
Our Services for IVD & Medical Device Market Registration in Indonesia
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
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
