Medical device consultancy

Are you up to date with your obligations as a Manufacturer, Importer, Authorised Representative, Distributor or Exporter?

Do you know which licences, registrations, and notifications you need to place your medical devices on the market?

Find what you need with our team of technical experts who’ll walk you through the entire process from start to finish.

I need more information?

What is it | Placing on the market | Registrations and procedures | Manufacturing license | Import license | Medical device export | Distribution in Spain and Portugal | Training and regulations | Specialized technical advisory

WHY CHOOSE A COMPREHENSIVE MEDICAL DEVICE CONSULTANCY SERVICE?

If you’re not sure about this and are wondering why, you probably need help from technical experts right through the entire process, from start to finish.

  • You get personalised advice on all the procedures required.
  • We help you meet your obligations under European legislation and its application in Spain and Portugal.
  • We keep you up to date with the regulations your medical devices have to comply with.
  • We provide logistics services for your medical devices in warehouses authorised by AEMPS (the Spanish Agency of Medicines and Medical Devices).

IF YOU’RE ONE OF THE FOUR MAIN ECONOMIC PLAYERS, THEN YOU’LL BE INTERESTED IN OUR MEDICAL DEVICE CONSULTANCY SERVICES

Get the best advice from expert technical consultants specialising in medical devices for placing your devices on the market in compliance with current legislation.

WHAT’S THE MOST IMPORTANT THING WHEN PLACING MEDICAL DEVICES ON THE MARKET?

There are a number of things you need to know to get your devices on the market:

  • PRIOR OPERATING LICENCE FOR MANUFACTURING AND/OR IMPORTING.

  • APPROVAL OF YOUR MEDICAL DEVICES.

  • GETTING CE MAKING (IF YOU’RE MANUFACTURER).

  • NOTIFICATION OF DISTRIBUTION OF THE DEVICES IN SPANISH REGIONS.

  • QUALITY MANAGEMENT: ISO 13485 (IF YOU’RE A MANUFACTURER).

  • REGISTRATION OF DEVICES ON THE CCPS (MEDICAL DEVICE MARKETING NOTIFICATION) PORTAL, EUDAMED PORTAL, INFARMED, ETC.

  • KEEPING UP TO DATE WITH NEW LEGISLATION ON THE APPLICATION OF LEGISLATION: REGULATION (EU) 2017/745, REGULATION (EU) 2017/746, REGULATION (EU) 2023/607 , SPANISH ROYAL DECREE 192/2023, ETC.

WHAT OTHER STEPS ARE ESSENTIAL OR IMPORTANT FOR PLACING A MEDICAL DEVICE ON THE MARKET?

There are several registrations and notifications which are essential and recommended for your medical devices.

EUDAMED REGISTRATION

As a Manufacturer, Authorised Representative and Importer you have to be registered in EUDAMED, the new database brought out by the European Union. To do this:

  • We register you in EUDAMED as an Economic Operator.
  • We register your products as an Economic Operator.

EU REPRESENTATIVE REGISTRATION

If you’re an Authorised Representative with a registered office in Spain, you have to be registered on the AEMPS RPS (Medical Devices Manager) platform. To do this:

  • We process your registration for the AEMPS RPS platform.

ISO 13485 QUALITY MANAGEMENT

If you’re a Manufacturer, Importer or Distributor, make sure your management complies with this standard.

  • We advise you on how to get ISO 13485 certification to endorse your quality management.

NATIONAL MEDICAL DEVICE CODE REGISTRATION

Is it essential to have a code to place medical devices on the market in pharmacies? If you’re an Importer and/or Distributor, it’s highly recommended you get the National Code for this type of product.

  • We process it at the Consortium of Pharmacists.

IF YOU’RE A MANUFACTURER, CONSOLIDATOR, STERILISER AND/OR IMPORTER: YOU NEED A PRIOR OPERATING LICENCE

We handle all the documents required to get a prior operating licence for facilities issued by AEMPS together with the technical documentation for your products.

  • We help you update all the documents needed to get a prior operating licence issued by AEMPS for your medical devices.
  • We’re there for you at every stage of the process to make it easier for you to meet your obligations.
  • Drawing up the Summary of Product Characteristics: we ensure your medical devices comply with applicable regulations.
I’M A MANUFACTURER AND I’D LIKE MORE INFORMATION

HOW CAN I GET AN IMPORT LICENCE FOR MEDICAL DEVICES?

An import licence is compulsory for medical devices.

  • We handle all the documentation with AEMPS to get your licence.
  • We apply to renew your import licence before it expires.
  • Don’t have a licence to import your devices? We help you import medical devices in compliance with regulations.
I’M AN IMPORTER AND I’D LIKE MORE INFORMATION.

WHAT DO I NEED TO DO IF I’M GOING TO EXPORT MEDICAL DEVICES?

If you’re looking to export your devices to a third country outside the European Union:

  • We manage the certificate of free sale issued by AEMPS, especially for Latin America, the Middle East, and China.
  • We come to your facilities to conduct quality reviews of the device prior to export.
I’M AN EXPORTER AND I’D LIKE MORE INFORMATION

THINKING OF DISTRIBUTING DEVICES IN SPAIN AND/OR PORTUGAL?

To distribute medical devices, you need to meet a few prerequisites:

  • We process the notification for medical device distribution in the Spanish region where your company is headquartered.
  • We handle notifications to place them on the market on the CCPS portal.
  • We see to registering you as a distributor in Portugal.
  • We register your medical devices on the INFARMED Portugal platform.
I’M A DISTRIBUTOR AND I’D LIKE MORE INFORMATION

NEED TRAINING FOR YOUR STAFF? ARE YOUR FACILITIES COMPLIANT WITH CURRENT REGULATIONS?

The advent of new legislation and regulations may affect your facilities, staff or standard operating procedures – how can we help you?

  • We come to your facilities to check whether they meet all the requirements.
  • We review your technical documentation.
  • We analyse your processes.
  • We advise you on approval of your products.
  • We provide the training you need.
FIND OUT ABOUT THE NEW REGULATIONS

ALL YOUR PROCEDURES, DOCUMENTATION AND OBLIGATIONS, HANDLED BY TECHNICAL EXPERTS.

We advise you on everything you need to do. Plus we also:

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