On 10 January 2022, the Indonesian Ministry of Health, following Regulation 14 of 2021, announced that it had introduced a simplified registration process for certain Class A Medical Devices.
It is no longer required, for these products, to follow the complete registration process. It is sufficient a notification which can be submitted via the online registration system on the website regalkes.kemkes.go.id.
Which Medical Devices can be registered via the simplified process in Indonesia?
At the time being, only some low-risk Class A Medical Devices, may be subject to the simplified notification procedure, among them:
- dental floss
- elastic bandages
- mechanical wheelchairs
- medical disposable bed linen
- mechanical walkers
- manual breast pumps
- teething rings
- ice bags
- limb and trunk braces
- medical insoles
- ophthalmic visors
- patient scale
If the Class A Medical Devices listed above have existing registrations, these remain valid until their expiration date. However, in the case of product changes requiring notification, a new device registration must be made using the simplified procedure.
With the simplified procedure, notification times are significantly reduced, making it easier to place many low-risk devices on the Indonesian market.
Do you need any kind of support to market your Medical Devices in Indonesia?
Thanks to the cooperation with partner companies in several extra European countries, our experts can support you in the preparation activities for the notification and registration of Medical Devices with local Regulatory Authorities.
>>> Find out how we can help you market your products in Indonesia.
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Online registration system, Kementerian Kesehatan Republik Indonesia, 10 January 2022
Online Registration System Guide, Directorate of General Pharmaceutical Service and Medical Device, 2022