Product Registration > The Ministry of Health (MOH)

The Ministry of Health of the Republic of Indonesia defines health tools and products as

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Who Applies The Rules?

Apparatus instruments, machines, implants that do not contain drugs used to prevent, diagnose, cure and relieve diseases, treat the sick and restore human health, and/or to form structures and improve bodily functions.

Requirements for Health Product Registration

Entrepreneurs who wish to trade medical devices in Indonesia must have several business licenses or licenses before registering with the Ministry of Health. The important documents are:

Business License

Registration License

Risk Evaluation

Medical Device Distributor License (IPAK)

Manufacturing Business License

Circulation License Number

Surveillance after Entering the Market