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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 Declaration of Conformity must be signed by a senior person in the legal manufacturer's organization (such as the Quality Director, Regulatory Affairs Director, or Chief Executive Officer) who has authority and 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​