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Classification Guidance — MDS-G008

What is MDS-G008?​

MDS-G008 is the SFDA's dedicated guidance document for medical device and IVD classification. It is the primary reference for interpreting the classification rules set out in MDS-REQ 1 and provides additional context for:

  • Borderline product determination (is this product a medical device?)
  • Annex XVI-type devices (devices without a medical intended purpose)
  • Difficult or ambiguous classification cases
  • Classification of novel device types
  • Interpretation of specific classification rules

Structure of MDS-G008​

MDS-G008 is organised into chapters covering:

ChapterContent
Chapter 1Scope of the Medical Devices Law — what is and is not a medical device; Annex XVI-type devices
Chapter 2General medical device classification rules — rule-by-rule interpretation guidance
Chapter 3Active device classification rules
Chapter 4Implantable device classification rules
Chapter 5IVD classification rules
Chapter 6Special categories — combination products, software, accessories

When to use MDS-G008​

Use MDS-G008 whenever:

  • You are unsure whether your product qualifies as a medical device in Saudi Arabia
  • The straightforward application of MDS-REQ 1 classification rules does not clearly resolve the class
  • Your device falls into a category not commonly encountered (novel technology, combination product, software, aesthetic device)
  • You need to justify your classification decision in the technical file with reference to SFDA guidance

Relationship to EU MDR classification guidance​

Because SFDA classification rules are identical to EU MDR Annex VIII, EU classification guidance documents — particularly MDCG 2021-24 (classification of medical devices) — can serve as supplementary references. However, MDS-G008 takes precedence for Saudi submissions. Where MDCG and MDS-G008 differ, apply MDS-G008.

Documenting classification in the technical file​

The technical file must include a classification justification section. Best practice:

  1. Identify the applicable classification rule(s) from MDS-REQ 1
  2. Reference MDS-G008 where interpretation is needed
  3. State the final class and the specific rule number(s) that led to that class
  4. Note if the highest applicable rule was applied (where multiple rules apply)
  5. Include a brief rationale if the classification is non-obvious

A well-documented classification justification reduces SFDA query likelihood during review.

Accessing MDS-G008​

MDS-G008 is published on the SFDA website under Medical Devices → Regulations and Guidance → Guidance Documents. Download the most current version, as guidance documents are periodically updated.

Further reading​