Disclaimer

1. General

Lepaz Africa BV (“Lepaz Africa”, “we”, “us”, or “our”), registered in The Netherlands (KvK: 42022407), operates the website at lepazafrica.com (the “Website”). By accessing and using this Website, you accept and agree to be bound by the terms of this disclaimer.

2. Nature of the information on this website

The information published on this Website — including but not limited to regulatory overviews, market access guides, country profiles, regulatory timelines, fee indications, and general market intelligence — is provided for general informational and educational purposes only.

This information:

• Does not constitute regulatory advice, legal advice, or professional consulting services;
• Should not be relied upon as the basis for any regulatory submission, commercial decision, or legal action;
• Is not a substitute for professional advice tailored to your specific device, product category, regulatory classification, target market, or commercial situation;
• Reflects information available at the time of publication and may not reflect subsequent regulatory changes, authority decisions, or policy developments.

Regulatory requirements across African markets change frequently. Timelines, fees, classification systems, reliance pathways, and local representation requirements are subject to change by the relevant regulatory authorities. Always verify current requirements directly with the relevant authority or through professional advice.

3. No professional relationship

Your use of this Website, or any communication with Lepaz Africa through the Website, does not create a client relationship or any other professional relationship between you and Lepaz Africa BV. A professional relationship is established only through a separately executed written engagement agreement.

4. Accuracy and completeness

Lepaz Africa makes reasonable efforts to ensure that the information on this Website is accurate and up to date at the time of publication. However, we make no representations or warranties, express or implied, as to the accuracy, completeness, reliability, suitability, or availability of any information on the Website.

We reserve the right to update, amend, or remove any content on the Website at any time without notice. Where content is marked with a “Last reviewed” date, that date indicates the most recent review but does not guarantee that all information is current.

5. Regulatory intelligence and market information

The Practical Registration Guides, market profiles, and regulatory intelligence content published on this Website are prepared based on publicly available information, direct engagement with regulatory authorities and in-country specialists, and our professional knowledge at the time of writing. They are intended to provide an informed starting point for manufacturers exploring African market access.

They do not replace:

• Country-specific regulatory strategy advice for your specific device and classification;
• Direct verification of current requirements with the relevant regulatory authority;
• Legal advice from a qualified attorney familiar with the applicable jurisdiction;
• Formal regulatory submissions or dossier preparation.

Lepaz Africa accepts no liability for any loss, damage, delay, or adverse outcome arising from reliance on information published on this Website without independent professional verification.

6. Third-party links and external content

This Website may contain links to external websites, including regulatory authority websites, industry bodies, and professional organisations. These links are provided for information purposes only. Lepaz Africa does not control, endorse, or accept responsibility for the content, accuracy, or availability of any external site. The inclusion of a link does not imply any affiliation or endorsement.

7. Limitation of liability

To the fullest extent permitted by applicable Dutch and EU law, Lepaz Africa BV excludes all liability for any direct, indirect, incidental, consequential, or special loss or damage arising from:

• Your use of, or inability to use, this Website or any content on it;
• Reliance on information published on this Website;
• Any interruption, suspension, or error in the availability of this Website;
• Unauthorised access to, or alteration of, your data transmitted to this Website;
• Any third-party content linked to or from this Website.

Nothing in this disclaimer limits or excludes our liability for death or personal injury caused by our negligence, fraud or fraudulent misrepresentation, or any other liability that cannot be excluded or limited under Dutch or EU law.

8. Intellectual property

All content on this Website — including text, graphics, logos, icons, images, and downloadable materials — is the property of Lepaz Africa BV or its content suppliers and is protected by applicable intellectual property laws. You may not reproduce, distribute, modify, or republish any content from this Website without the prior written consent of Lepaz Africa BV.

You are permitted to print or download content from this Website for your own personal, non-commercial reference, provided that you do not modify the content and that you acknowledge Lepaz Africa as the source.

9. Governing law and jurisdiction

This disclaimer and any dispute arising from your use of this Website shall be governed by and construed in accordance with the laws of the Netherlands. Any disputes shall be subject to the exclusive jurisdiction of the competent courts of The Hague (Den Haag), the Netherlands.

10. Contact

If you have questions about this disclaimer or wish to report a concern about content on this Website, please contact us: