SFDA item 53 · II. Quality changes · II.5 Drug containing medical device
Change in specification parameters and/or limits 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 53 — official PDF, p. 65 ↗
| Variant | Change | Type |
|---|---|---|
| a | Tightening of specification limits | Type IA |
| b | Addition of a new specification parameter to the specification | Type IA |
| c | Widening of the approved specifications limits, which has a significant effect on the overall quality of the device | Type II |
| d | Deletion of a specification parameter that has a significant effect on the overall quality of the device | Type II |
| e | Addition of a specification parameter as a result of a safety or quality issue | Type IB |
| f | Deletion of a non-significant specification parameter (e. g deletion of an obsolete test) | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 53.
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 specification 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
- 54 · Change in test procedure 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.