When COVID-19 hit, the demand for medical equipment in Indonesia increased rapidly. However, this was not matched by the existing stock of equipment. Therefore, the need for the importation of medical equipment in Indonesia has also increased. So how about importing medical equipment to Indonesia?
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Medical Equipment in Indonesia
Basically, most of the medical products and devices in Indonesia are from imports. The imported devices are also many sophisticated devices. In addition, Indonesia also imports some raw materials that are not available in Indonesia.
This is because Indonesia still can not produce these medical products. However, recently, the Indonesian government is trying hard to ensure that Indonesia can independently meet the needs of its medical community.
Types of Medical Devices and Equipment in Indonesia
The importation of medical devices and equipment in Indonesia is divided into 3 areas, namely:
1. Medical Devices.
First, this category concerns devices that are commonly used in the medical world. Examples of this category such as masks to heart stents.
2. In-vitro Diagnostic Devices.
Second, in vitro diagnostic devices are devices that are normally used in performing medical tests. For instance, including blood test kits, donor kits, etc.
3. PKRT (Household Health Care Services).
Third, household health care service or PKRT, are tools, materials, or a mixture of materials for the preservation and maintenance of human health. Generally, this is intended for households and public institutions.
Medical Devices Classification in Indonesia
Whether you want to import medical devices into Indonesia or distribute them, knowing which class of the device is important.
This is because medical device class affects the registration requirements. Henceforth, the higher the class of the medical device, the more information is required regarding registration requirements.
Based on these risks, medical devices are classified into four classes, as follows:
1. Low Risk / Class A
Class A is a medical device that has a low risk when used. Examples of medical devices that fall into this category include film viewers, surgical instruments, surgical gloves, and oxygen masks.
2. Low to Moderate Risk / Class B
Class B is a medical device that poses a low-to-moderate risk when used. For example, blood pressure cuff, steam sterilizer.
3. Moderate to High Risk / Class C
Class C is a medical device that poses a moderate to high risk when used. Patient monitor and X-Ray Machine are the example of this classification.
4. High Risk / Class D
Last, the riskiest medical device will be put into Class D. For instance, Cardiac Stent and Pacemaker are the device that belongs to the class D.
Documents Required to Import Medical Devices into Indonesia
Before importing medical devices from Indonesia, you need to prepare some documents. For example:
1. HS Code of The Product
First, it is essential to find out the HS code of your products. Inside the HS Code, you will find some important information, such as import taxes and additional documents required or lartas.
To check them, you can use our HS Code explorer for simple and faster looking. For example, I will find the HS Code of the surgical mask after clicking the link above.
After that, click on the result. In order to import surgical masks to Indonesia, you need to pay several taxes first. Moreover, pay attention also to the additional documents or lartas.
2. Distributor License
Second, make sure to obtain the distributor license before importing medical devices and equipment to Indonesia. Obtaining distributor license came from the Ministry of the health of Indonesia.
If you wish to apply for a distribution permit, the applicant must be a medical device distributor or a medical device manufacturer who already holds a medical device manufacturing certificate.
You can also check the detail of the Distributor license inside the HS Code.
How to Import Medical Devices into Indonesia
All medical devices to be imported, distributed, or used in the territory of Indonesia must first obtain a distribution permit.
If you wish to apply for a distribution permit, the applicant must be a medical device distributor or a medical device manufacturer who already holds a medical device manufacturing certificate.
Hence, having a legal company in Indonesia is necessary to import medical devices into Indonesia. However, handling all the administration and the bureaucracy will take time to finish.
Subsequently, the process of importing itself can be inefficient for your business if you handle it alone. Especially if you want to focus on your core business first.
Therefore, using third-party services such as Kickrate’s Importer of record (IoR) may be beneficial for your import-export activities. We will handle all the administration and bureaucracy for you. Contact us for more information.
