Does Saudi Arabia mandate that a CE Mark for a Medical Device is Required?

[Bunny]

Does Saudi Arabia mandate that a CE Mark for a medical device is required? Or is it just "preferred"? I can't seem to locate a firm answer in the Saudi FDA Guidance document.
Thanks.

[MIREGMGR]

Saudi Arabia requires that imported devices be legally marketable (and, generally, actually marketed) in at least one GHTF-member country/region (i.e. USA, EU/EFTA, Canada, Australia, Japan). A CE Mark on labeling would not be sufficient evidence of such status. Instead the relevant CE Certificate would be required to be provided.

For a device that's marketed in USA, an alternate evidence-form for Saudi Arabia would be a US FDA Certificate to Foreign Government.

[sreenu927]

Submission Requirements:
1. Contact details for the manufacturer
2. contact details and establishment National Registry number for the Authorised Representative
3. Name and Contact information of person responsible for completing application form
4. Information, including listing number assigned to it by the SFDA, on medical device
5. Documents proving medical device complies with at least one of the GHTF founding member (US, EU, Japan, Canada, Australia) jurisdictions, including:
- classification of the medical device
- evidence of compliance with the conformity assessment requirements, including any registration or listing requirements
- evidence that the manufacturer's quality management system is in place (if aplicable);
- the location of technical documents supporting the claim that the manufacturer's medical device is not subject to review by the Regulatory Authority (RA) (if applicable)
- A declaration to attest that the medical device complies with regulations within the GHTF founding member jurisdiction and the national provision of the MDIR
6. electronic copy of the labeling
7. electronic copy of the IFU
8. Declaration of Conformity
9. Ensure proper storage, transportation, installation and maintenance of medical devices in KSA and that users can be trained in proper use
electronic copy of advertising and marketing materials that will be used in the KSA (if applicable)

Regards,
Sreenu

[jinggu]

I'm agonizing over this issue also. One of my customer keeps asking for a Declaration of Conformity. I cannot draw up one as of yet because we're still in the process of doing notification to our EU representative. And the batch detained at the customs are not CE-marked yet. They had been made aware of the situation before we shipped out the product. So I'm wondering what could be a equally sufficient document to provide to clear the product. Appreciate any advice.

[MIREGMGR]

Have you considered a US FDA Certificate to Foreign Government?

[jinggu]

I'm contacting the customer to see if this is one of the documents we already provided.
I'll post the update if it works out.

[Bunny]

Does anyone know if testing to IEC 60601-1 3rd Edition is required in Saudi? Or when it will be required?

[MIREGMGR]

In Reply to Parent Post by Bunny

Does anyone know if testing to IEC 60601-1 3rd Edition is required in Saudi? Or when it will be required?

Saudi Arabia's existing system is based on provision of evidence that an imported device may legally be marketed in its country of origin.

For devices originating in USA or the EC, of types for which IEC 60601 is relevant and depending on device classification, a requirement for its application already might exist in the country of origin.