Professional Medical Device Marketing Authorization (NIE)
made Easier with Us
A dedicated authorization number for imported medical devices. We help accelerate compliance with Ministry of Health standards so your healthcare technology can be legally distributed without unnecessary delay.
What is a Medical Device NIE?
A Marketing Authorization Number (NIE) is an authorization issued by the Ministry of Health (AKD/AKL) for medical devices to ensure the function, safety, and quality of medical products.
WHY IS AN AKL MARKETING AUTHORIZATION IMPORTANT FOR YOUR BUSINESS?
Credibility and Safety Assurance
An official marketing authorization demonstrates that your medical device has passed the required safety and quality assessments. It is essential for building trust among physicians, hospitals, and healthcare professionals.
Broader Access to the Healthcare Market
It is mandatory for distributing products to public and private hospitals, clinics, and pharmacies, as well as for participating in medical procurement tenders through the e-Catalogue.
Legal Risk Mitigation
Protects your business from administrative sanctions, product seizure, and potential criminal liability arising from the distribution of unauthorized medical devices.
Competitive Advantage
Products with an AKL NIE have a significantly stronger market position and bargaining power.
Simple in
4 Steps
A simple, transparent, and hassle-free process. We handle the administrative complexity so you can focus on growing your business.
Free Consultation
Discuss your business needs with our expert team.
Submit Documents
Send the required documents securely online.
Application Process
Our legal team handles the process with the relevant authorities.
Documents Completed
Your official documents are completed and delivered to you.
Choose Your Package
Transparent pricing with no hidden fees. Build a strong legal foundation for your business with Awan Kusuma.
Basic Package
Essential assistance with an AKL NIE application, suitable for first-time applicants.
- Initial consultation on requirements and required documents
- Assistance with document collection
- NIE registration submission to the Ministry of Health/BPOM
- Process monitoring until the NIE is issued
- Company Documents
- ISO 13485 Certificate (Quality Management System for Medical Devices)
- Certificate of Free Sale (CFS)
- Technical file
- Certificate of Analysis (CoA)
- Import documents
- Other Supporting Documents
Premium Package
Comprehensive support, including laboratory testing and document revisions, for a more efficient process.
- All features included in the Basic Package
- Assistance with laboratory testing in Indonesia
- Revision of technical documents
- Consultation on medical device regulations and requirements
- Assistance until the product is ready for market
- All requirements included in the Basic package
- Product samples for laboratory testing
- Additional documents requested by the Ministry of Health/BPOM
Enterprise Package
An end-to-end solution for larger businesses, from licensing through marketing strategy.
- All features included in the Premium Package
- Support in resolving issues during the registration process
- Document translation service
- Post-issuance NIE support
- Consultation on product marketing and distribution strategy
- All requirements included in the Basic and Premium packages
- Product marketing or distribution plan
Real Proof of
Trust
First-hand experiences from clients who have used our Medical Device Marketing Authorization (NIE) service.
"I have always been satisfied with Awan Kusuma's services. Their team handled my business licensing issues professionally and provided valuable insight and guidance for future licensing matters, helping my business operate smoothly."
Feli
Client
"During my time using your services, everything was truly pleasant and easy to work with. They were responsive, communicative, and all my needs were handled well and on time. Most importantly, they were incredibly trustworthy, which gave me peace of mind throughout the process. Thank you for helping me handle everything. If I have any more legal needs in the future, I'll definitely use your services again."
Misshell
Client
"The service from the Awan Kusuma Legalitas Team has been very helpful for a layperson like me in determining the type of business allocation. They are very capable and professional. Thank you, Awan Kusuma Legalitas."
Rudy
Client
Contact Us
Have a specific question about our Medical Device Marketing Authorization (NIE) service?
Frequently Asked
Questions
Find quick answers to common questions about Medical Device Marketing Authorization (NIE).
A distributor must hold a Medical Device Distribution Standards Certificate (SDAK, formerly IPAK), while a manufacturer must hold a Production Certificate. Without the applicable facility authorization, the system will not accept a product marketing authorization application.
It's easy. Click the 'Contact Us via WhatsApp' button on this page, or fill out the contact form, and our team will contact you in less than 1 business day.
No need. The entire consultation and document collection process can be done online. The notarial deed can be signed anywhere or through a special power of attorney.
