Medical Device
Medical Device Registration Services in Indonesia
Given Indonesia’s reliance on imported medical devices, foreign investors should consider investing in this sector. With medical device registration services in Indonesia, you can avoid roadblocks to your business’s growth.
A. Medical Device License: How to Obtain One
Before entering the Indonesian market, every medical device must be registered with the Indonesian government. The Ministry of Health of the Republic of Indonesia is the primary government agency in charge of ensuring the safety and compliance of these products (MOH).
Before issuing a medical device license, the MOH will evaluate and classify each product based on risk level, using Indonesian Ministry of Health regulations and guidance, ranging from class A (the lowest) to class D (the highest). In general, the more complicated the document registration process, the higher the risk. In this case, seeking expert assistance will save time.
B. Requirements for Medical Device Registration in Indonesia
In Indonesia, the registration of medical devices begins with the eligible party applying the MOH’s online system. In addition, the applicant must submit administration and technical quality documents, an executive summary of the product, a device description, risk analysis, and manufacturer information.
Foreign investors may face difficulties in providing these documents and complying with regulations and MOH requests because they require in-depth knowledge of processes. Even registered products are not permitted to enter the Indonesian market unless the Distribution License for Medical Devices is obtained. Contact us for help with medical device registration.
C. Medical Device Registration Services in Indonesia With Abisnis
- STARTING A COMPANY
According to Indonesian law, only a legal company can register and distribute medical devices throughout the country. This could make it difficult for foreign investors to enter the market. Abisnis, a well-known market-entry consulting firm in Indonesia, assists you with registering your company and obtaining a medical device import license with fewer obstacles. - PRODUCT LICENSE HOLDER SERVICES
Abisnis is eligible to register medical devices in Indonesia as a registered company with a Medical Device Distributor License (IDAK). Foreign investors do not need to incorporate a legal entity in Indonesia to register their medical devices under a Special Purpose Agreement. - EXTENSION OF DISTRIBUTION LICENSE FOR MEDICAL DEVICES
A medical device distribution license is valid for five years and must be renewed at least nine months before it expires. Contact Abisnis to renew your license before it expires and avoid having to re-register your medical equipment.
D. Medical Device Registration Services in Indonesia: The Workflow
| PROCEDURE Legal Entity Registration at the Ministry of Health -> Class Determination and Product Registration |
| BASIC REQUIREMENTS 1. Manufacturer/Principal Overseas - Letter of Authorization - Certificate of Free Sales - ISO Certification of Manufacturing Site 2. Indonesia legal entity - Import License - Medical Device Distributor License - Trade Business License - Company Tax ID |
E. Why Choose Abisnis for Medical Device Registration in Indonesia?
- SEAMLESS PRODUCT REGISTRATION
We handle the registration of your medical device with minimal complications thanks to our knowledge of Indonesian regulations. - WE ALWAYS HAVE SOLUTIONS
We can register your medical devices securely and seamlessly, whether you have a company or not. - ONE-STOP SERVICES
In addition to medical device registration, our consultants can quickly get your medical products Halal certified. - TIME AND COST SAVING
Abisnis handles your time-consuming paperwork for product registration and eliminates delays.
