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