Export and Free Sale Certificates for Medical Devices Issued by AEMPS in Spain

1. Definition and Purpose

The Certificates of Export / Free Sale (Certificados de exportación-libre venta, CERTPS-CLV) are documents issued by the Spanish Agency for Medicines and Medical Devices (AEMPS) to support Spanish companies exporting medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs) to non-EU countries. These certificates attest that the company and products comply with applicable Spanish and European legislation at the time of issuance. They are often required by importing countries but do not constitute a marketing authorization.

AEMPS Certificates of Export / Free Sale for Medical Devices

There are two types: certificates of free sale (for CE-marked products) and certificates of export (including for non-CE marked products intended solely for export).

2. Eligibility and Applicable Products

Eligible applicants are companies established in Spain acting as manufacturers, importers, assemblers, EU authorized representatives, or distributors exporting to non-EU countries.

Covered products include:

• Medical devices under Regulation (EU) 2017/745 and related Spanish decrees.
• Active implantable devices under the same regulation.
• IVDs under Regulation (EU) 2017/746.
• Legacy devices under older directives during transitional periods.
• Non-CE marked products manufactured solely for export (only for licensed manufacturers).

Certificates are not issued for products outside AEMPS competence.

AEMPS Certificates of Export / Free Sale for Medical Devices

3. Application Procedure

Applications are submitted exclusively online via the CERTPS-CLV platform. Companies request access by emailing AEMPS, which provides credentials. The platform allows submission, corrections, withdrawals, downloads, and status checks.

AEMPS Certificates of Export / Free Sale for Medical Devices

4. Processing Time and Fees

Processing takes a maximum of 10 business days if documentation is complete. Additional requests reset the timeline.

A fee applies per certificate, paid online via the platform.

AEMPS Certificates of Export / Free Sale for Medical Devices

5. Validity and Format

Certificates have no fixed validity period, reflecting compliance at issuance. They are bilingual (Spanish/English), electronic, with electronic signatures.

Authenticity can be verified online. Hague Apostille is automatic for signatory countries; otherwise, additional legalization is needed.

AEMPS Certificates of Export / Free Sale for Medical Devices

6. Specific Considerations

• Non-CE marked products: Specified as for export only.
• IVDs: Separate provisions under EU and Spanish regulations.
• Contact for queries: soportecertps@aemps.es

AEMPS Certificates of Export / Free Sale for Medical Devices

7. Legal Basis

Based on EU Regulations 2017/745 and 2017/746, various Spanish Royal Decrees (e.g., 192/2023, 942/2025), and transitional provisions from older directives.

AEMPS Certificates of Export / Free Sale for Medical Devices