Master Medical Devices Registration United Arab Emirates

In this course, I will take you through an interesting journey towards the highly dynamic market in the middle east region, we will fly together to the business hub of the middle east region, we will travel to the United Arab Emirates, and we will go to Dubai and learn everything about medical devices placing in this highly interesting market.

This course will lead you from the start to the end of the process of placing medical devices in the market of the United Arab Emirates, we will explore together all aspects related to the regulatory activities and tools that help us to place our medical devices in a such dynamic market.

This course is structured to act as a guide or a manual that you just have to follow step by step that will lead you smoothly towards the whole process.

We will start with classification as the usual basic backbone step towards any product registration in any country

we will go through the classification guidelines and match them with the 3 basic classes of medical devices, normal medical devices, in-vitro medical devices, and active medical devices.

Then will move to the manufacturer, along with its proof of quality compliance, which is the ISO 13485, and then will explore together the different CE certificate approvals in Europe.

Then we will dive deeper into the medical devices  Registration Guidance issued in 2011, and still valid now.

We will stop at the flow chart of the whole process of medical device registration in the UAE.

And then we will use all these tools to build up our submission dossier, will go through the documents checklist, forms, and templates, and prepare them.

We will explain the term”Pharmaceutical Like Dosage Forms” for high-risk classes of medical devices, and how to deal with such a situation.

And then will close the course with the renewal and its flow chart, in addition to the updated circulars issued by the Ministry of Health and Prevention of the United Arab Emirates.

I hope that you enjoyed the flight.

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