Terms of Service

These terms govern your use of this website. By using the site you accept them. If you do not accept them, please do not use the site.

1. Nature of the information provided

All content on this website is provided for general information only. It does not constitute regulatory, legal or professional advice, and must not be relied upon as such. Regulatory requirements, fees, processing times and validity periods are determined by the Medical Device Authority and other competent authorities, and are subject to change without notice.

You should not act, or refrain from acting, on the basis of anything on this site without obtaining advice specific to your circumstances.

2. No regulatory authority or endorsement

CerturaCo Regulatory Consultancy is an independent consultancy. We are not the Medical Device Authority (MDA), the Ministry of Health Malaysia, a Conformity Assessment Body, an accreditation body, or a certification body. We are not affiliated with, appointed by, or endorsed by any of them. References to these bodies are descriptive only.

3. No guarantee of outcome

Registration, licensing and certification decisions rest solely with the relevant authorities and accredited bodies. We do not and cannot guarantee that any application will be approved, that any certification will be granted, or that any particular timeline will be achieved. Any timelines we provide are planning estimates based on the information available to us.

4. Engagement terms

Nothing on this website constitutes an offer to provide services, and submitting an enquiry does not create a consultancy relationship. Services are provided only under a separate written engagement agreement setting out scope, fees, responsibilities and deliverables. Where these terms conflict with a signed engagement agreement, the engagement agreement prevails.

5. Your responsibilities

Where you engage us, the accuracy and completeness of the information and documentation you supply remains your responsibility. Regulatory obligations relating to your devices and establishment remain yours at all times; our role is to advise and assist, not to assume those obligations.

6. Intellectual property

All content on this website — text, layout, graphics and design — is the property of CerturaCo Regulatory Consultancy unless otherwise stated. You may view and print content for your own internal reference. You may not republish, redistribute or use it commercially without written permission.

7. Third-party links

This site may link to external resources. We provide those links for convenience and are not responsible for the content, accuracy or availability of external sites.

8. Limitation of liability

To the fullest extent permitted by Malaysian law, we exclude liability for any loss or damage arising from use of, or reliance on, this website or its content, including indirect or consequential loss. Nothing in these terms excludes liability that cannot lawfully be excluded.

9. Privacy

Our handling of personal data is described in our Privacy Policy.

10. Governing law

These terms are governed by the laws of Malaysia, and the courts of Malaysia have exclusive jurisdiction over any dispute arising from them.

11. Contact

Questions about these terms: info@certuraco.com