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How to identify and confirm that the developed device fall under Israel electro medical device category


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Hi All,

Required clarification as below

As per Israel medical device registration process certain electro medical device requires Israel standard institution validation and certification is to be obtained in order to ensure product quality and safety.

A manufacturer develops a infusion pump and he anticipate that his device fall under electro medical device category.

How to Confirm and identify that his device fall Under the electro medical device category as per ISRAEL standard institution (ISI) and do he need to submit his device for validation and certification with ISI. Is there any specific Category list of electro medical device as per Israel?

Is israel standards institution published any list of electro medical device category which needs validation and certification for getting medical device clearance in Israel?

Please help me out
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