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.
Get Expert HelpKey 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.