meeting in business

Medical Device License: how to obtain one

The Indonesian government requires every medical device to be registered before entering the local market. The main government body that ensures the safety and compliance of these products is the Ministry of Health of the Republic of Indonesia (MOH).

Before issuing a medical device license, the MOH will evaluate and classify every product based on risk level by referring to Indonesian Ministry of Health regulations and guidances, ranging from class A (the lowest) to class D (the highest). In general, the higher the risk, the more complicated the document registration process. In this case, seeking assistance from experts will save time.

Talk to our experts

Requirements for medical device registration in Indonesia

The registration of medical devices in Indonesia starts with the eligible party applying through the MOH’s online system. The applicant must also submit several documents such as administration and technical quality documents, an executive summary of the product, a device description, risk analysis, and manufacturer information.

Providing these documents and aligning with the regulation and MOH requests can be challenging for foreign investors as they require an in-depth knowledge of processes. Even registered products are not entitled to enter the Indonesian market unless they are granted the Distribution License for Medical Devices.

Register your product
woman in office

Medical Device Registration Services in Indonesia with InCorp

According to domestic law, only a legal company in Indonesia can register and distribute medical devices across the country. This could pose a great challenge for foreign investors to enter the market. As a notable market-entry consulting firm in Indonesia, InCorp, with its comprehensive business solutions, helps you with the registration of your company and assists you in obtaining a medical device import license with fewer hurdles.

As a registered company with a Medical Device Distributor License (IDAK), InCorp is eligible to register medical devices in Indonesia.

A medical device distribution license is valid for five years, and distributors need to extend the license at least nine months before it expires. Contact InCorp Indonesia to extend your license before it expires and avoid re-registration of your medical equipment.

Medical Device Registration Services in Indonesia: The Workflow

medical device registration in Indonesia

Why Choose InCorp Indonesia for Medical Device Registration?

1
SEAMLESS PRODUCT REGISTRATION

With our expertise in Indonesia’s regulations, we handle the registration of your medical device with minimum obstacles.

2
WE ALWAYS HAVE SOLUTIONS

With or without establishing a company, we can get your medical devices registered securely and seamlessly.

3
ONE-STOP SERVICES

In addition to medical device registration, our consultants can get your medical products Halal certified in a seamless way.

4
TIME AND COST-SAVING

InCorp Indonesia handles your hefty paperwork requirements for product registration and rules out delays.

Pandu Biasramadhan

Senior Consulting Manager at InCorp Indonesia

An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.

Get in touch with us.

Lead Form

Disclaimer: The information is provided by PT. Cekindo Business International (“InCorp Indonesia/ we”) for general purpose only and we make no representations or warranties of any kind.

We do not act as an authorized government or non-government provider for official documents and services, which is issued by the Government of the Republic of Indonesia or its appointed officials.

We do not promote any official government document or services of the Government of the Republic of Indonesia, including but not limited to, business identifiers, health and welfare assistance programs and benefits, unclaimed tax rebate, electronic travel visa and authorization, passports in this website.

Frequent Asked Questions

Yes, license holder and distributor of medical devices must have Medical Device Distribution License (Izin Penyalur Alat Kesehatan/IPAK).

There will be specific documents from Manufacturing/Factory, Indonesian Legal Entity, and Product documents. Contact InCorp Indonesia for more details.

The medical devices license called Izin Edar Alat Kesehatan (AKL) will be valid up to 5 years, depending on the Letter of Authorization from the Principle (product owner).

Yes, there are 2 options you may choose. The first option is appointing an existing distributor and the second option is appointing InCorp Indonesia to be the license holder.

In general, the registration will take between 3 to 6 months. However, it all depends on the classification of your medical device. Class 1A, it may take 3 - 4 months, class 2B and 2C may take 4-5 months and class 3D may take up to 6 months

What Our Clients Say

China Fortune Land
Development Co,. Ltd
After comparing several consultants, I found InCorp Indonesia is a international and professional organization with good understanding of local market. InCorp Indonesia helped our company to set up our first Indonesian entity, and also helps with day-to-day operation. InCorp Indonesia showed high level of professionalism. Jump start the business in Indonesia, take care of routine process, therefore we can focus more on our core business.
Desmi
Cekindo provided outstanding services in registering our representative office in Indonesia in a timely manner. Their financial services have been helping us a lot — our local employees feel secure working for our company. Cekindo became our reliable partner with quick response on our needs. Their flexibility and full support of our business in Indonesia are the main reasons to continue in our cooperation.
PT AESK
We chose Cekindo because we considered Cekindo as a professional company with a good attitude and a streamlined business model. Cekindo met all our expectations as it created the atmosphere of accountability and transparency. The most significant added values that we received from cooperation with Cekindo are the time we saved and mistakes we avoided.
Sedbergh, Ltd.
We were searching for suitable partner for the begining of our operation on Indonesian market. After short exploration and recommendation from our business partners we decided for Cekindo. Local knowledge, orientation at our business problematics, contacts and language. In a friendly approach combined with professional service. Consultation before the project – avoids so much unnecessary act of “foreigners” worse overview of the Indonesian legislative.
LEC GROUP
We were searching for suitable partner for the begining of our operation on Indonesian market. After short exploration and recommendation from our business partners we decided for Cekindo. Local knowledge, orientation at our business problematics, contacts and language. In a friendly approach combined with professional service. Consultation before the project – avoids so much unnecessary act of “foreigners” worse overview of the Indonesian legislative.
Our Clients Find This Helpful. Please Review.
Rating: 4.6/5. From 14 votes.
Please wait...