Registration in Spain
Placing medical devices and IVDs on the Spanish market require an additional registration to be performed with the Spanish Agency for Medicines and Health Products (AEMPS) as per the Spanish Royal Decree No.1591/2009, of the 16th of October and the No.1662/2000, of the 29th of September. Four categories of medical devices and three categories of IVDs require to be registered with the Spanish Agency for Medicines and Health Products (AEMPS) at the time of being put into service within Spanish territory.
Categories of medical devices/IVDs concerned by this obligatory communication are:
- Class IIa medical devices
- Class IIb medical devices
- Class III medical devices
- Active implantable medical devices (AIMDD)
- IVD Self-Testing
- IVD Annex II, List A
- IVD Annex II, List B
The registration process consists of following 5 steps:
- Designation of an E.A.R.!
- Provide E.A.R. with relevant documentation (to be provided upon request)
- A.R reviews your documentation
- AR communicates the information by using the Official AEMPS Web-Portal
- A.R provides you with an acknowledgement of delivery and Certificate
Medical devices having same intended use (same commercial name, the same EC declaration of conformity and the instruction for use) are subject to only one communication. The communication must be made at least 30 days before putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the Spanish territory.
Please bear in mind, that if the communication is not submitted at the time the device is put into service, the Spanish Laws are laying down penalties for the contraveners.
Third party commercial entities, like distributors, should not register devices for several reasons, a few of which are:
- By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in the European Market (such as in France);
- If decided to end the relationship with a commercial distributor at any point, it will be required to take the device completely off the market until a re-registration is completed for a second (third, fourth, etc.) time;
- Third party commercial entity will expect exclusivity, limiting the open distribution of devices.
- For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
- The manufacturer should register their products with the Spanish Authorities through his appointed Authorized Representative.
Local Legislations, such as this one, are common in Europe (Italy, Portugal, France, Greece, Latvia, Bulgaria and Croatia)
On 26 May 2021, Medical Device Regulation (EU) 2017/745 will repeal Medical Device Directive 93/42/EEC. Until EUDAMED database allowing registration at EU level is functional, current- Directive registration process will continue. Nevertheless, Member States might continue requesting a separate registration to their national database.
If you are importing cosmetics products directly to Spanish ports, be aware that Spanish Agency for Medicines and Health Products (AEMPS) must be informed of it, by submitting a self-declaration (Declaración Responsble) and by paying the respective TAX. Do not forget that this does not replace the mandatory CPNP notification before you place your cosmetic product on the Spanish market.
Food supplements may be subject to the requirements of the national registration as a pre-market authorization. For more information, contact us today!
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