If it is to achieve a consistent success, the primary task of any business entity should be being legally acceptable. I want you to know the legal principle- “Ignorance of the law excuses no man from practicing it”. This simply means- A person who is unaware of a law may not escape liability for violating that law merely by being unaware of its content. Therefore, it is very important to understand which of your activities are legal and which are not when running your business.

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As per Article 67 Sub-article (4) of the same proclamation, If you manufacture or sale or import or store or distribute for public use a medical device without a license or MA certificate or with fake license or MA Certificate, you will be punished by imprisonment from three to five years and with a fine from 5k to 100k birr.

Food and Medicine Administration Proclamation No: 1112/2019 was approved by House of Peoples Representatives of Ethiopia and in effect since February 2019. This proclamation as you may guess encompasses all products that are regulated by Ethiopian Food and Drug Authority. With respect to medical device, most of the proclamation’s contents are modified from its previous version (Proclamation No: 661/2009) starting from exclusion of medical device from medicine’s definition.

I have attached the Scanned PDF version of the latest proclamation (Proclamation No: 1112/2019) below. You can download and read its full contents.

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