SFDA - KINGDOM OF SAUDI ARABIA MEDICAL
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:
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 SFDA’s request, translate the relevant part of the document where a summary is provided.
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
6. Provide information on any measures taken to accommodate the
specific environmental and/or conditions of use encountered in the KSA,
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 SFDA’s National Centre for Medical Device Reporting (NCMDR), any
relevant adverse event of which it becomes aware, that involves the
di consulenza per FDA Stati Uniti, SFDA Cina, CMDR Canada, JPAL Giappone, KFDA Corea,
ANVISA Brasile, SFDA Arabia Saudita, Ministero salute INDIA, CE Unione Europea, EVICR.net