SFDA item 54 · II. Quality changes · II.5 Drug containing medical device
Change in test procedure of a measuring or administration device for veterinary medicinal products
Variation category under SFDA, EU and US FDA rules for this change, with the variant wording as published.
SFDA Saudi Food and Drug Authority
Guidelines for Variation Requirements v6.3 (DS-G-006), item 54 — official PDF, p. 66 ↗
| Variant | Change | Type |
|---|---|---|
| a | Minor change to an approved test procedure | Type IA |
| b | Other changes to a test procedure (including replacement or addition) | Type IA |
| c | Deletion of a test procedure if an alternative test procedure is already authorized | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 54.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Veterinary medicinal products are outside C/2025/5045, which covers medicinal products for human use. EU veterinary variations follow Regulation (EU) 2019/6 (Articles 60–62) and Implementing Regulation (EU) 2021/17.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — Not covered by 21 CFR 314.70 (veterinary; FDA CVM, 21 CFR 514.8)
| Change | Category | Reference |
|---|---|---|
| Any test-procedure change for a veterinary device | No US equivalent |
Note: Not covered by 21 CFR 314.70 (human drugs, NDA/ANDA); veterinary products fall under FDA CVM rules (21 CFR 514.8).
Other items in II.5 Drug containing medical device
- 52 · Change of a measuring or administration device
- 53 · Change in specification parameters and/or limits of a measuring or administration device for veterinary medicinal products.
Not regulatory advice. The binding text is each regulator's current official document; confirm the category with the authority before filing. FDA publishes no classification table: the US category follows FDA guidance or, where the guidance does not name the change, the closest example under 21 CFR 314.70.