Medical Device Registration Services in Indonesia
Given Indonesia’s reliance on imported medical devices, this sector presents a treasured opportunity for foreign investors. Avoid any obstacles that may hurdle your business expansion objectives with medical device registration services in Indonesia..
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.
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.
Medical Device Registration Services in Indonesia with Indo Prime
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, Indo Prime, 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), Indo Prime 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 Indo Prime Indonesia to extend your license before it expires and avoid re-registration of your medical equipment.
Medical Device Registration Services in Indonesia: The Workflow
Why Choose Indo Prime Indonesia for Medical Device Registration?
With our expertise in Indonesia’s regulations, we handle the registration of your medical device with minimum obstacles.
With or without establishing a company, we can get your medical devices registered securely and seamlessly.
In addition to medical device registration, our consultants can get your medical products Halal certified in a seamless way.
Indo Prime Indonesia handles your hefty paperwork requirements for product registration and rules out delays.
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Frequent Asked Questions
There are two main types, namely, primary business licenses and non-primary business licenses. The primary ones commonly apply to various industries, such as general and industrial business licenses. Additional non-primary ones are included, depending on the operations of your business. Examples of non-primary business licenses are operational and commercial licenses.
Yes, you must apply for it to be able to issue work permits for your foreign employees. This permanent business license is also a prerequisite for the applications for other business licenses and import licenses.
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