The Indonesian Ministry of Health has published a guidebook for Grouping of Medical Devices and In Vitro Diagnostic Devices recently. According to the guidebook, Medical Devices and IVD can be grouped and registered in one application to get one marketing authorization. The grouping is divided into Single, System, Family, IVD Test Kit, IVD System and Group.
The medical device can be grouped if met following condition:
1. Has same intended use.
2. Used in combination to achieve the intended purpose.
3. Similarity in products for simplification of marketing authorization.
If the products fulfill above condition, then the products can be grouped as below
‣ IVD product can be grouped in Single, Family, IVD Test Kit and IVD System.
‣ Medical Device product can be grouped in Single, Family, System, Group.
Single Medical Device that sold in various packaging sizes can be registered in 1 application. For examples condoms which packed in 3, 12 and 144 contents can be registered under 1 license. Besides, single medical device also possible to be used with several other devices such as CT-Scan software which can be used with a several CT scans machines produced by other product owners.
Meanwhile for System, IVD Test Kit and Group if the product sold with accessories that come from a different manufacturer, then a letter of appointment from each manufacturer and proof that these accessories can be used together with the System / IVD Test Kit / Group are required. It is important to note that only if the component inside the System / IVD Test Kit / Group are to be used in closed system then the device can be registered in 1 application. It means that if the component can be used with other medical devices, then it can’t be registered in 1 application. Lastly for Group, each component must be registered first prior include it in a group. If the list of component is the same only have different in size or total content, then it can be register as 1 application. However, if manufacturer decide to have several packed with different components, then it must be registered in separate application
For Detailed Regulation, please refer to Medical Device Grouping Guidelines in Indonesia.
References:
Grouping of Medical Device and DIV