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Declaration of Conformity

What is the Declaration of Conformity?​

The Declaration of Conformity (DoC) is a document signed by the legal manufacturer declaring that the medical device complies with the applicable Essential Principles of Safety and Performance under Saudi Arabian law. It is a required component of every MDMA technical file.

The SFDA Annex 14 template​

The SFDA provides a specific DoC template in Annex 14 of MDS-REQ 1. Manufacturers must use this template — or a document that contains all required elements in the same format. Generic DoC documents (e.g. EU Declaration of Conformity) may not be accepted as a substitute.

The DoC must include:

  • Legal manufacturer name and address
  • Device name, model(s), and catalogue numbers
  • Device classification and applicable classification rule
  • Statement of conformity with SFDA Essential Principles
  • Reference to applicable standards and guidance documents used
  • Authorized Representative details (name and address in Saudi Arabia)
  • Signature and date of the legal manufacturer's authorised signatory
  • Name and title of the signatory

Who signs the DoC?​

The DoC must be signed by a senior person in the legal manufacturer's organisation with responsibility for regulatory compliance. It is not signed by the AR — the AR is named on the DoC but does not sign it.

When must the DoC be updated?​

The DoC must be updated:

  • When a significant device change is made
  • At MDMA renewal
  • When the AR changes

Further reading​