Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
February 6, 2026
Approximately 5 minutes
BASG Certificates of Free Sale for Medical Devices Exported from Austria
BASG Certificates of Free Sale for Medical Devices Exported from Austria
1. Purpose of Certificates of Free Sale
Certificates of Free Sale (CFS) confirm that CE-marked medical devices are freely sold in the European Union and thus in Austria. They are required by some non-EU countries for import registration. Additionally, BASG issues confirmations for products not classified as medical devices but which might be perceived as such in third countries. Source: BASG Certificate of Free Sale Page https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale
2. Eligibility
Applications can only be submitted by manufacturers or authorised representatives established in Austria. CFS are issued only for devices with valid CE marking. Confirmations are available for non-medical products. Source: BASG Certificate of Free Sale Page https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale
3. Required Documents
Applications must include:
- Completed and signed application form.
- Copy of valid CE certificate (or declaration of conformity for Class I devices).
- For confirmations: Evidence that the product is not a medical device (e.g., classification decision).
- Power of attorney if applicable. Source: BASG Certificate of Free Sale Page https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale
4. Application Process
Submit applications via email to medizinprodukte@basg.gv.at with subject line containing the procedure number if known. BASG reviews completeness and may request supplements. Processing time: Approximately 4 weeks after complete submission. Certificates are issued in German and English. Source: BASG Certificate of Free Sale Page https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale
5. Fees
Fees are charged per the current Fee Ordinance:
- CFS for medical devices: Standard fee.
- Confirmations for non-medical products: Separate fee. Exact amounts listed in the ordinance. Source: BASG Certificate of Free Sale Page https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale
6. Contact
For questions: medizinprodukte@basg.gv.at Source: BASG Certificate of Free Sale Page https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
BASG Confirmation Process for Exporting Non-Medical Devices to Third Countries
The Austrian BASG issues confirmations (CNM) for products not marketed as medical devices in the EU but potentially perceived as such abroad, facilitating export by Austrian-based manufacturers or representatives through a formal application process with fees.
Approximately 5 minutes
Austrian BASG Role in Designating and Monitoring Notified Bodies for Medical Devices
The Austrian BASG designates and monitors Notified Bodies responsible for conformity assessments under MDR and IVDR, following a structured application and assessment process with ongoing annual audits and European coordination via NANDO.