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SFDA - KINGDOM OF SAUDI ARABIA MEDICAL DEVICES REGULATIONS


Saudi Food and Drug Authority - Medical Devices Marketing Authorisation

The manufacturer or its authorised representative shall for the medical devices it wishes to place on the market of the KSA:

1. Provide the required documents that show the medical device complies with the Medical Device Regulations of at least one of the GHTF Founding Member jurisdictions.
2. Provide the documents in the English language and where the documents provided are in a language other than English, a summary, or translation, of the document shall be provided to the SFDA in English.
3. At the SFDAs request, translate the relevant part of the document where a summary is provided.
4. Provide a Declaration of Conformity, written in English, that clearly identifies to which medical devices the Declaration applies and attests that its medical device complies with the regulatory requirements of the relevant GHTF Founding Member jurisdiction and also complies with the national provisions of this Interim Regulation.
5. Provide a copy of the labelling associated with the medical device, in English and/ or Arabic language, and ensure that the text of the different elements of the labelling and their content take account of the intended use of the devices and the qualifications of the users in the KSA.
6. Provide information on any measures taken to accommodate the specific environmental and/or conditions of use encountered in the KSA, if any.
7. Specify measures to ensure its medical devices are correctly stored, transported, installed and maintained in the KSA, and users can be trained in their proper use.
8. Undertake to report to the SFDAs National Centre for Medical Device Reporting (NCMDR), any relevant adverse event of which it becomes aware, that involves the medical device
                                                                                                       

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