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

B

Bunny

#1
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.
 
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M

MIREGMGR

#2
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

Quite Involved in Discussions
#3
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
 
J

jinggu

#4
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.
 
J

jinggu

#6
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.
 
B

Bunny

#7
Does anyone know if testing to IEC 60601-1 3rd Edition is required in Saudi? Or when it will be required?
 
M

MIREGMGR

#8
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.
 
B

Bunny

#9
I want to be sure I understand.

So, if we (the manufacturer) declare that our device meets the requirements to be legally marketed in Europe and IEC 60601 testing applies for our type of device, we would assume that the same IEC 60601 requirement that applies in the EU would apply in Saudi.

IEC 60601 3rd edition took effect in EU in June 2012. So, we would have to have our testing meet that edition. Correct?
 
M

MIREGMGR

#10
I note that your "Location" is USA. If you're discussing a US-manufactured device, I think the certification you would provide to Saudi authorities would be a US FDA Certificate to Foreign Government, certifying that your device is legally marketable in USA. Thus US FDA's usage of IEC 60601 would be regulatorily relevant.

However, responding to your question about a device originating in EU: for a device that has been introduced to the EU market since that particular regulatory-requirement evolution, my understanding would agree with your statement. You would certify to the Saudi authorities that your device is legally marketable in its country of origin. If it originates in EU, your certification would be that it meets relevant EC requirements.

As a caveat, I don't know how Saudi Arabia handles devices that are newly introduced to the Saudi regulatory system but have been on the market in USA or Europe for long enough that some of their regulatory aspects are to previous rules/guidances/standards.
 
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