IVD Medical Device Registration in Indonesia
Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements by the government in Indonesia.
Why Register Your IVD Medical Device in Indonesia?
Access to a Growing Market
Access to a Growing Market
The demand for advanced diagnostic solutions is on the rise in Indonesia, driven by increased healthcare spending and a growing awareness of the importance of early disease detection. By registering your IVD device in Indonesia, you tap into a large and emerging market with significant growth potential.
Regulatory Compliance
Regulatory Compliance
Registering your IVD device ensures compliance with the regulatory requirements set by the Indonesian Ministry of Health. This compliance not only helps in avoiding legal issues but also builds trust and credibility with healthcare providers.
Potential Market Entry and Expansion
Potential Market Entry and Expansion
Successfully registering your IVD device is the first step towards establishing a strong market presence in Indonesia. It enables collaborations with local distributors, healthcare institutions, and government programs. Additionally, it lays the foundation for future product launches and market expansion strategies.
Our IVD Medical Device Registration Services
Regulatory Strategy
Tailored regulatory strategy based on your medical device's classification and target market in Indonesia.
Dossier Preparation
Compiling and reviewing all necessary documentation in compliance with Kemenkes requirements.
Submission Management
Managing the entire submission process, including communication with Kemenkes.
Post-Market Compliance
Assist in adverse event reporting, change notifications and more.
Registration Process Overview
Step 1: Classification
Medical devices in Indonesia are classified into three main categories as it dictates the regulatory requirements and submission details:
- Medical Devices (Alat Kesehatan)
- In Vitro Diagnostics (Diagnostik in Vitro)
- Household Health Supplies (Perbekalan Kesehatan Rumah Tangga or PKRT)
Medical devices in Indonesia are classified based on risk in accordance with the ASEAN Medical Device Directive (AMDD):
- Class A: Low Risk
- Class B: Low to Moderate Risk
- Class C: Moderate to High Risk
- Class D: High Risk
- Class 1: Low Risk
- Class 2: Moderate Risk
- Class 3: High Risk
Step 2: Submission
Prepare and submit the necessary documents to the regulatory authority. This includes:
- product specifications
- labelling
- evidence of compliance with safety and performance standards
Step 3: Evaluation
The submission process is facilitated through the Kemenkes platform, which integrates the ASEAN Common Submission Dossier Template (CSDT). Once submitted, your application will be assessed by the regulatory authority to ensure all criteria are met.
Step 4: Approval
After a successful evaluation, the Indonesian Ministry of Health will issue a Distribution Approval Number or NIE (Nomor Izin Edar), also known as the Product Approval Licence. This authorization allows you to market and distribute your device within Indonesia.
Step 1: Classification
Medical devices in Indonesia are classified into three main categories as it dictates the regulatory requirements and submission details:
- Medical Devices (Alat Kesehatan)
- In Vitro Diagnostics (Diagnostik in Vitro)
- Household Health Supplies (Perbekalan Kesehatan Rumah Tangga or PKRT)
Medical devices in Indonesia are classified based on risk in accordance with the ASEAN Medical Device Directive (AMDD):
- Class A: Low Risk
- Class B: Low to Moderate Risk
- Class C: Moderate to High Risk
- Class D: High Risk
- Class 1: Low Risk
- Class 2: Moderate Risk
- Class 3: High Risk
Step 2: Submission
Prepare and submit the necessary documents to the regulatory authority. This includes:
- product specifications
- labelling
- evidence of compliance with safety and performance standards
Step 3: Evaluation
The submission process is facilitated through the Kemenkes platform, which integrates the ASEAN Common Submission Dossier Template (CSDT). Once submitted, your application will be assessed by the regulatory authority to ensure all criteria are met.
Step 4: Approval
After a successful evaluation, the Indonesian Ministry of Health will issue a Distribution Approval Number or NIE (Nomor Izin Edar), also known as the Product Approval Licence. This authorization allows you to market and distribute your device within Indonesia.
Typical Fees and Timeline (biaya dan timeline)
Payment must be made within 7 (seven) calendar days. For whatever reason if payment is not processed within the deadline, the submission will expire, and a new submission will be required
- Arm sling
- Body waste receptacle
- Cane
- Cane, crutch and walker tips and pads
- Cold pack
- Crutch
- Dental floss
- Elastic bandage
- Floatation cushion
- Hernia support
- Hot or cold disposable pack
- Hot/cold water bottle
- Ice bag
- Limb orthosis
- Manual breast pump
- Manual toothbrush
- Mechanical wheelchair
- Mechanical walker
- Medical adhesive tape and adhesive bandage
- Medical disposable bedding
- Medical insole
- Moist heat pack
- Nipple shield
- Non-resorbable gauze/sponge for external use
- Ophthalmic eye shield
- OTC Denture cleanser
- Patient scale
- Protective garment for incontinence
- Scented or scented deodorized menstrual pad
- Stand-on patient scale
- Teething ring
- Therapeutic massager
- Truncal orthosis
- Unscented menstrual pad
- Tissue and cotton
- Laundry Preparation
- Cleaner
- Baby and mother care products
- Antiseptic and disinfectant
- Fragrance
Class | Fee | Timeline |
---|---|---|
Class A | IDR 1,500,000 | Maximum of working 45 days |
Class B and Class C | IDR 3,000,000 | Maximum of 60 days |
Class D | IDR 5,000,000 | Maximum of 80 days |
Class | Fee | Timeline |
---|---|---|
Class A | IDR 500,000 | Maximum of working 34 days |
Class B, C and D | IDR 1,000,000 |