Before a medical device can be legally marketed in Indonesia, it must obtain the appropriate registration. Two terms commonly used in this process are AKD and AKL. 

Although both refer to medical device registration, the main difference lies in where the product is manufactured. 

What is AKD? 

AKD, or Alat Kesehatan Dalam Negeri, applies to medical devices manufactured in Indonesia. 

Products under this category are registered as domestically manufactured medical devices. This pathway is relevant for Indonesian manufacturers, product owners working with local manufacturing partners, and companies planning to localize production in Indonesia. 

However, local production must still comply with applicable licensing, quality, and technical documentation requirements before the product can be legally distributed. 

In simple terms: 

Manufactured in Indonesia = AKD 

What is AKL? 

AKL, or Alat Kesehatan Luar Negeri, applies to medical devices manufactured outside Indonesia. 

Imported medical devices must obtain AKL registration before they can be legally imported, distributed, and marketed in the country. 

Foreign manufacturers generally need to work with an eligible local company to manage the registration and fulfill regulatory obligations in Indonesia. The appointment of this local party should be carefully considered, as it may affect registration control, importation, distribution arrangements, and long-term market strategy. 

In simple terms: 

Manufactured outside Indonesia = AKL 

Why Does the Difference Matter? 

The registration category is based on the product’s manufacturing location, not the location of the company’s headquarters. 

For example, a foreign company manufacturing through an eligible Indonesian facility may follow the AKD pathway. Meanwhile, an Indonesian company importing a product manufactured overseas would generally need AKL registration. 

Identifying the correct pathway from the beginning helps prevent document gaps, application revisions, additional costs, and registration delays. 

Before starting the process, companies should review the product classification, manufacturing arrangement, intended use, technical documents, labeling, and applicable licensing requirements. 

A clear regulatory assessment can help companies choose the appropriate pathway and prepare a smoother route toward legally marketing their medical devices in Indonesia. 

Contact Mursmedic for your regulatory needs and market access into Indonesia through the WhatsApp button on the bottom right corner.