I’m relatively new to Spain and recently, a friend and I were thinking about starting a small business, setting our sights on the medical device sector. At first, I thought that as long as we had a supplier and obtained CE certification within the EU, it would be smooth sailing. However, after some research, I realized it’s not that simple. To legally sell in Spain, you have to deal with an agency called AEMPS, the Spanish Agency of Medicines and Medical Devices. Today, I’m organizing what I’ve learned to share with fellow forum members who might need it, so we can all exchange ideas.
What is AEMPS Registration?
Simply put, if you are a medical device manufacturer, an authorized representative, or an importer/distributor wanting to sell your products on the Spanish market, you must first apply to AEMPS for an operating license. Only after obtaining this license can you proceed with the subsequent product registration. This process ensures that all medical devices circulating in the Spanish market comply with both EU and local Spanish regulations, guaranteeing product safety and traceability. The whole process has become even stricter, especially since the implementation of the new EU Medical Device Regulation (MDR).
The entire application process is mostly done online, primarily by submitting documents through the official AEMPS system. I’ve organized the core steps for MDR certification and the necessary materials into a table to make it easier for everyone to follow:
| Step | Main Task | Key Documents/Requirements |
|---|
| Step 1: Apply for an Operating License | The company must first obtain the qualification to sell medical devices in Spain. | 1. Company’s legal information, tax ID (NIF)<br>2. At least one qualified Technical Responsible Person (Responsable Técnico)<br>3. Quality Management System (QMS) documentation<br>4. Proof of office/warehouse address |
| Step 2: Product Filing/Registration | Inform AEMPS of the specific products to be sold. | 1. Product’s CE Declaration of Conformity<br>2. Product labels and instructions for use (IFU)<br>3. EU Authorized Representative (EC-REP) information<br>4. Notified Body certificate, depending on the product’s risk class |
Important Reminder: The Technical Responsible Person is a critical requirement! AEMPS has strict criteria for this position, typically requiring a relevant university degree and work experience. Many small businesses get stuck here, forcing them to either qualify themselves or hire a professional to represent them on contract. This is a considerable expense that you must account for in your initial planning, a common challenge you’ll hear about even at industry events like Expodental.
Honestly, the whole process is quite cumbersome, and dealing with all the forms and technical documents can be a headache. If it’s your first time and your Spanish isn’t fluent, I’d recommend hiring a professional consulting firm to handle it. Although it costs a service fee, it can save you a ton of time and effort. Most importantly, it ensures all your documents are correct the first time, preventing rejections due to non-compliance that could delay your product launch. A friend of mine tried to do it all themselves and got their application rejected because of an incorrect document format. The back-and-forth wasted nearly two months—a lesson learned the hard way. I hope my sharing this helps you all!
