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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.

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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. Contact our consultants for seamless medical device registration.

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Medical Device Registration Services in Indonesia With Cekindo

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, Cekindo, 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), Cekindo is eligible to register medical devices in Indonesia. Under a Special Purpose Agreement, foreign investors do not need to incorporate a legal entity in Indonesia to register their medical devices.

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 Cekindo to extend your license before it expires and avoid re-registration of your medical equipment.

Medical Device Registration Services in Indonesia: The Workflow

Understanding The Different Types of Visas in Indonesia

Why Choose Cekindo for Medical Device Registration in Indonesia?

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

What Our Clients Say

michal_jerabek_cekindo business partner
Sedbergh, Ltd.
My Linh Hoangova
ELC Group
(CFLD), Mr. Max Yang, President, Indonesian Region
China Fortune Land Development Co., Ltd.
DESMI Testimonial - Cekindo
DESMI
Konstantin-Simonov
PT AESK

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.

Herewith we want to express our appreciation to PT. Cekindo Business International and their team for all the support on medical devices services so far. We would like to take this opportunity to thank Cekindo for taking the time to listen to our needs. Whenever a need has arisen, we have always received their consistent, timely and quality support. We would not hesitate to recommend Cekindo team for any related activity or services.

After comparing several consultants, I found Cekindo is a international and professional organization with good understanding of local market. Cekindo helped our company to set up our first Indonesian entity, and also helps with day-to-day operation.  Cekindo 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.

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.

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.

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FAQs

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

Currently, Indonesia holds a four-grade risk evaluation system as follows:

  • Category A (low risk) - if mishandled or not used properly, medical device is not harmful to humans.
  • Category B (low to moderate risk) - if mishandled or not used properly, medical device can have some serious effects but will not be considered as a serious accident to humans.
  • Category C (moderate to high risk) - if mishandled or not used properly, medical device can have very serious effects but will not be considered as a serious accident to humans.
  • Category D (high risk) - if mishandled or not used properly, medical device can have some serious effects and will be considered as a serious accident to humans.