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Ten categories of medical devices to be registered in Indonesia

In order to ensure the service quality of medical institutions and ensure the health and safety of the people, the Indonesian government has formulated the Import and Production Guidelines for the Medical Device Market. The guidelines were issued by the Ministry of Health and Welfare on October 6, 2005 and came into effect on March 1, 2006. The guidelines only address the following ten categories of sterile devices:

1. Cardiac stents;

2. Drug-containing stents;

3. Catheters;

4. Keratoscopy;

5. Syringe;

6. Bone adhesive;

7. Heart valves;

8. Intravenous infusion needle;

9. Orthopedic implants;

10. Artificial implants.

The import of the above 10 categories of products into Indonesia requires the approval of the Ministry of Health and Welfare, registration and import authorization in accordance with the procedures set out in the Medicines and Cosmetics Act of Indonesia.

How to enter the Indonesian market faster

The Indonesian government does not regulate or officially define most medical devices. Most medical devices are not licensed to enter the Indian market. The quality of the product is evaluated by the buyer, i.e. public hospital, private hospital or doctors. Generally speaking, products approved by the US Food and Drug Administration (FDA) and the EU CE are of good quality and performance and will be given priority. However, the Indonesian market is very price sensitive and there will be a large market for low-cost medical devices.

Ten categories of medical devices to be registered in Indonesia

How to enter the Indonesian market faster

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