Professional assistance for medical device registration, licensing, CDAKB certification, and regulatory compliance in Indonesia.
Medical devices are instruments, machines, implants, reagents, or equipment used for diagnosing, preventing, monitoring, treating, or rehabilitating human health conditions. These products range from simple devices such as thermometers and blood pressure monitors to advanced medical technologies such as ventilators, laboratory instruments, and imaging systems.
The demand for medical devices in Indonesia continues to grow along with the development of hospitals, clinics, laboratories, and healthcare facilities. As a result, many companies import, manufacture, and distribute medical devices to meet market needs.
Because medical devices directly impact patient safety, they must comply with strict regulatory requirements before being distributed in Indonesia.
Why Medical Device Licensing Services Are Needed
The regulatory process for medical devices in Indonesia is complex and involves administrative, technical, and compliance requirements. Companies must understand product classification, documentation standards, and evolving regulations issued by the Ministry of Health.
Medical device licensing services help companies handle these requirements efficiently. With professional assistance, businesses can reduce administrative errors, accelerate approval processes, and ensure compliance with applicable regulations.
Medical Device Regulations in Indonesia
Medical device distribution in Indonesia is regulated by government authorities, particularly the Ministry of Health.
Key regulations include:
- Law No. 17 of 2023 on Health
- Ministry of Health regulations on medical devices
- Marketing authorization requirements
- Good Distribution Practice for Medical Devices (CDAKB)
- OSS-RBA risk-based licensing system
These regulations ensure that all medical devices meet safety, quality, and performance standards before entering the market.
Services in Medical Device Licensing
Medical Device Registration
Registration is a mandatory process before medical devices can be legally distributed in Indonesia. It includes review of technical, administrative, and safety documentation.
Consultants assist in preparing documents and managing the submission process until approval is obtained.
Marketing Authorization
Marketing authorization is required to legally sell medical devices in Indonesia. Without it, products cannot enter the market.
Consulting services help ensure compliance and manage the approval process effectively.
CDAKB Certification
CDAKB ensures that distributors maintain proper systems for storing and distributing medical devices safely and effectively.
It includes warehouse management, documentation systems, and quality control procedures.
OSS-RBA Assistance
Medical device companies must comply with OSS-RBA business licensing requirements, including correct business classification and regulatory commitments.
Consultants assist with registration, classification updates, and licensing compliance.
Process of Medical Device Licensing
1. Product Classification
Determining risk level and regulatory category.
2. Documentation Preparation
Preparing technical and legal documents.
3. Submission
Submitting applications through the official system.
4. Evaluation
Regulatory review of submitted documents.
5. Approval
Issuance of license for legal distribution.
Challenges in Medical Device Licensing
- Incorrect product classification
- Missing technical documents
- Changing regulations
- System input errors
- Lack of regulatory understanding
Benefits of Using Medical Device Licensing Services
- Faster approval process
- Lower rejection risk
- Regulatory compliance assurance
- Professional guidance
- Time and cost efficiency
- Easier market access
Contact Us
Biruni Consulting provides professional assistance for medical device licensing, registration, CDAKB certification, and OSS-RBA compliance in Indonesia.
We help companies ensure full regulatory compliance and smooth market entry for medical devices.
If you need professional medical device licensing services, Biruni Consulting is ready to support your business
