Medical Device Registration Indonesia
Overview
The Medical Device and Product Licensing Service assists in registering your medical devices and products in Indonesia. We ensure compliance with the Ministry of Health (MOH) regulations through the e-Certification system. Business Hub Asia guarantees adherence to all licensing procedures, enabling the legal sale and use of your products within the Indonesian market.
Free ConsultationKey Features
Medical Product Classification Consultation
Identify the medical device category (class A, B, C, D) and type of license required, including risk and surveillance status.
Medical Device Registration Permit (AKL/Akes)
Register local and imported medical devices through the Ministry of Health's e-Registration system to obtain an official distribution permit number.
Application for Medical Device Distribution License (IPAK)
Assistance for medical device distributors and importers includes audit support and distribution facility documentation.
Technical Document Preparation & Labeling
Assistance in preparing technical documents, test results, quality certificates (ISO 13485), and label design according to the requirements of the Ministry of Health.
Assistance for Imported Medical Product Registration
Medical device registration requires: overseas principal appointment letter (LoA), CPP/FSC, and country of origin certification.
Minimum Requirements
Company legality
NIB, NPWP, Deed, SIUP
Distributor License
Medical Device Distributor License (for distributors)
Technical & Clinical Docs
Product technical specifications & clinical/laboratory test certificates
Importer Documents
Circulation permit holder documents (for imported products)
Labeling Requirements
Product label and packaging in the Indonesian language
Sectors requiring Medical Device License
Medical Device Manufacturers & Importers
Laboratories & Diagnostic Companies
Hospitals & Clinics
Medical Technology Company
Process and Timeline
1
Product Consultation & Classification
Determine the product category (Class A-D based on risk). Classification affects complete requirements. Estimated time: 1-2 business days.
2
Technical Document Collection & Validation
Gather technical files, ISO 13485 certificates, clinical studies, Indonesian labels & manuals. Estimated time: 10-20 working days depending on complexity.
3
Submission via Ministry of Health e-Registration
Upload documents via Regalkes (Ministry of Health’s specialized OSS system). Inspection time:
Class A: ~15 days
Class B-C: ~30 days
Class D: ~45 days
4
Evaluation & Verification Process by MOH
Examination of device completeness and eligibility, possible manufacturer/importer audit. Estimated time: Included in the above estimate.
5
Issuance of Circulation License
Upon completion of the evaluation, issuance of a certificate for distribution. Estimated time: Immediately after evaluation is completed.
*The total time required for medical device registration is about 2-3 months. The medical device license is valid for 5 years and can be renewed.
Important Consideration
- All medical devices to be marketed in Indonesia must have a distribution license from the Ministry of Health.
- Products with a high risk classification (class C and D) require more stringent paperwork and technical evaluation.
- The distribution license is valid for 5 years and can be extended.
- Imported products must have an authorized local distributor who possesses a Medical Device Distributor Permit (IPAK).
Frequently Asked Questions
What kind of products are required to have a medical device license?
All types of medical equipment, from thermometers and medical masks to ventilators and surgical instruments, are required to have a distribution permit from the Ministry of Health before being marketed.
What is the difference between AKL and AKD?
AKL (Local Medical Device): for products manufactured in Indonesia.
AKD (Medical Device Distribution): for imported products.
Does my product have to be laboratory tested first?
Yes. Testing is required to prove the safety, effectiveness, and quality of the product, depending on the risk classification.
Who can apply for a distribution license?
Local manufacturers or authorized distributors (who have an IPAK) can apply for a distribution license for medical devices.
What is the process for imported products?
To import medical devices, applicants need to submit: a letter of appointment from the foreign manufacturer, a Certificate of Free Sale or Certificate of Pharmaceutical Product, and technical documentation that adheres to Indonesian regulations.
Can one company have more than one medical device license?
Yes, because each product and type of medical device requires a separate distribution permit number.
Register Your Products with Confidence
Navigate the complex product registration process for food, cosmetics, health, and other regulated products efficiently and compliantly.
Disclaimer
The content provided on this website is published by PT. Bisnis Hub Asia (“we“, or “us“) for general informational purposes only. While every effort is made to ensure the accuracy and timeliness of the information presented, we make no representations or warranties, express or implied, as to the completeness, accuracy, reliability, suitability, or availability of any content, products, or services described on this website. Any reliance placed on such information is strictly at the user’s own risk.
We are a private, independent entity and are not affiliated with, authorized by, or acting on behalf of the Government of the Republic of Indonesia, its ministries, agencies, or any officially appointed representatives. This website does not provide, offer, or promote any official government documents or services, including but not limited to:
-
Business identification numbers (Nomor Induk Berusaha – NIB);
-
Tax refunds or rebates;
-
Stay Permit or electronic travel authorizations;
-
Passports or other immigration-related documents.
Any references to such services are provided solely for general informational purposes and should not be construed as an offer or facilitation of official services.
We are committed to ensuring the protection of your personal data in accordance with Law No. 27 of 2022 on Personal Data Protection. Any personal information collected through this website will be processed for the purposes clearly stated in our [Privacy Statement]. We do not sell or misuse personal data under any circumstances.
By accessing and using this website, you acknowledge and agree to the terms set out in this Disclaimer. You further agree to use this website and the information provided responsibly and in compliance with applicable laws and regulations.
For further information or questions regarding this Disclaimer, please contact us via the channels provided on our Contact page.
Disclaimer
The content provided on this website is published by PT. Bisnis Hub Asia (“we“, or “us“) for general informational purposes only. While every effort is made to ensure the accuracy and timeliness of the information presented, we make no representations or warranties, express or implied, as to the completeness, accuracy, reliability, suitability, or availability of any content, products, or services described on this website. Any reliance placed on such information is strictly at the user’s own risk.
We are a private, independent entity and are not affiliated with, authorized by, or acting on behalf of the Government of the Republic of Indonesia, its ministries, agencies, or any officially appointed representatives. This website does not provide, offer, or promote any official government documents or services, including but not limited to:
-
Business identification numbers (Nomor Induk Berusaha – NIB);
-
Tax refunds or rebates;
-
Visas or electronic travel authorizations (e-Visa, e-VoA);
-
Passports or other immigration-related documents.
Any references to such services are provided solely for general informational purposes and should not be construed as an offer or facilitation of official services.
We are committed to ensuring the protection of your personal data in accordance with Law No. 27 of 2022 on Personal Data Protection. Any personal information collected through this website will be processed for the purposes clearly stated in our [Privacy Statement]. We do not sell or misuse personal data under any circumstances.
By accessing and using this website, you acknowledge and agree to the terms set out in this Disclaimer. You further agree to use this website and the information provided responsibly and in compliance with applicable laws and regulations.
For further information or questions regarding this Disclaimer, please contact us via the channels provided on our Contact page.
Meet the Expert
Meet the Expert
Edy Tama, SH, LLM.
Chief Operating Officer at Business Hub Asia
Edy Tama is a seasoned legal and compliance executive with over 20 years of experience in Indonesia and Southeast Asia. As COO at Business Hub Asia, he oversees day-to-day operations and ensures regulatory integrity across legal, licensing, and client service teams. His core expertise is in corporate law, regulatory compliance, and risk management for international clients in emerging markets.
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