Medical Device Registration - Insightof Consulting

Medical Devices Product Registration

Ensuring Compliance for Safe Medical Device Distribution

Legal Compliance

It is mandatory for all medical devices to be registered with the Ministry of Health before being distributed in Indonesia.

Market Access

Gain entry to one of Southeast Asia’s largest and growing healthcare markets.

Patient Safety

Contribute to the overall well-being of the Indonesian population by ensuring your products are safe and effective.

What is Medical Device Product Registration?

Medical Device Product Registration is the legal process required to ensure your medical devices meet the regulatory standards set by the Indonesian Ministry of Health. It ensures that only safe, effective, and compliant products are available for use in Indonesia.

Medical Device Category

Electromedic Radiation

Medical devices that use radiation for diagnosis or treatment, such as X-ray or radiation therapy machines.

Electromedic Non-Radiation

Medical devices that use electrical energy but do not emit radiation, like ECG machines or ultrasound devices.

Non-Electromedic Sterile

Medical devices that do not use electricity and are sterile, such as surgical instruments or implants.

Non-Electromedic Non-Sterile

Non-electric medical devices that are not sterile, including bandages and splints

Diagnostic In-Vitro

Medical devices used to test samples outside the body, such as blood test kits or lab equipment.

Medical Device Classification

Class 1A (Low Risk)

Includes devices such as hospital beds and bandages.

Class 2B (Low-Moderate Risk)

Includes devices like infusion pumps and diagnostic equipment.

Class 2C (Moderate-High Risk)

Includes devices such as ventilators and surgical lasers.

Class 3D (High Risk)

Includes devices like implantable pacemakers and defibrillators.

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How to Register Your Medical Device

Identify Your Product Category and Class

Based on medical device category and medical device classification.

Prepare the Necessary Documents

Company registration and licensing documents , Product specifications and labelling, Risk classification and assessment reports, Clinical trial data (for Class 2C & 3D), Declaration of Conformity

Ensure Warehouse Compliance

Meet storage, labeling, and traceability standards.

Submit Your Application

Apply through the Directorate General of Pharmaceutical and Medical Devices (Regalkes)

Pay the PNBP Fee

Complete payment of the Non-Tax State Revenue fee.

Receive Your IDAK Certificate

Obtain certification after your application is approved.

Basic Document Requirement

Notarial Deed of Company Establishment

Business Identification Number (NIB) – 46691

Taxpayer Identification Number (NPWP)

Building/Warehouse Floor Plan and Equipment

Pictures of Workspaces and Warehouse

SOP for Storage, Reception and Distribution of Goods

Technical Responsible Person (PJT)

Technician

Have any questions about Medical Device Registration?

We’re here to help! Our team of experts provides clear guidance and support to ensure a seamless registration process, from understanding regulations to obtaining approval.

INSIGHTOF Consulting

Your Regulatory Experts

Address

Wisma PMI 6th Floor Jl. Wijaya I No.63, RT.8/RW.1, Petogogan, Kec. Kby. Baru, Kota Jakarta Selatan, Daerah Khusus Ibukota Jakarta 12160

Mail Address

marketing@insightof.co.id

+62 897 6470 070

Phone

(021) 7279 3812

Working Hours

Mon to Fri : 08:00 AM – 17:00 PM

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