Lately, more and more friends on the forum are discussing entrepreneurship, which is great to see! I’ve noticed several people asking about starting companies and import/export trade. As it happens, I just finished helping a friend with a rather tricky task—medical device registration. So, I decided to document the whole process and the pitfalls I encountered to share with anyone who might need it.
To be honest, dealing with government agencies in Spain can be a real headache. This time, the medical device registration certificate we needed was for the import and sale of a Class II medical device. Initially, we thought it was like any other product—just clear customs and pay taxes. But we got stuck at customs; they required a permit from the Spanish Agency of Medicines and Medical Devices (AEMPS), which is what we commonly refer to as the medical device registration or license.
The Core License: Licencia Previa de Funcionamiento
Simply put, any company that wants to manufacture, import, or sell medical devices in Spain must first obtain this so-called ‘Licencia Previa de Funcionamiento de empresas de productos sanitarios’. It’s a prerequisite license; you can’t do anything without it. Applying for this license is the most complex and time-consuming part of the whole process. You need to submit a ton of company documents, technical files, and proof of a quality management system to AEMPS. You also have to appoint a technical director, who must have a relevant professional background and qualifications, and bears significant responsibility.
The entire application process is mostly digital and must be submitted online through the official AEMPS platform. But don’t get too excited—the document review is extremely strict, and having to submit supplementary materials back and forth is the norm. We were held up for a long time due to an issue with our technical director’s qualifications. I highly recommend hiring an experienced professional or a gestoría to handle it. Trying to figure it all out on your own is a huge waste of time, and don’t ask me how I know.
Product Registration: Comunicación de comercialización
After getting the company-level operating license, you’re not done yet! Every specific product you sell also needs to be individually notified to or registered with AEMPS. This step is relatively simpler and is called ‘Comunicación de comercialización’. You’ll need to submit the product’s CE certificate, instruction manual, labels, and other information. The process can vary slightly depending on the product’s risk class. I’ve created a simple table here to help you understand the responsibilities of the different parties involved:
| Party | Main Responsibility |
|---|
| Manufacturer | Responsible for product design, production, and CE certification |
| EU Authorized Representative | Required if the manufacturer is outside the EU |
| Importer | Responsible for bringing the product from a non-EU country and ensuring compliance |
| Distributor | Responsible for storage and sales within the distribution chain |
Medical devices are a highly regulated field in Spain, and the barrier to entry is not low. If you only plan to sell low-risk Class I products like band-aids or medical cotton swabs, the process is much simpler; you might only need to make a ‘Declaración Responsable’. However, for any slightly more complex device, you must strictly follow the AEMPS regulations. I hope my experience can be of some help to you all. Wishing all you entrepreneurs great success!
