SFDA item 52 · II. Quality changes · II.5 Drug containing medical device
Change of a measuring or administration device
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 52 — official PDF, p. 64 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Addition or replacement of a device which is not an integrated part of the primary packaging — Spacer device for metered dose inhalers or other device which may have a significant impact on the delivery of the active substance in the product (e.g. nebuliser) | Type II |
| a.2 | Addition or replacement of a device which is not an integrated part of the primary packaging — Certified Device (for example with MDMA) | Type IA(IN) |
| a.3 | Addition or replacement of a device which is not an integrated part of the primary packaging — Non certified Device for veterinary products only | Type IB |
| b | Deletion of a device | Type IA(IN) |
| c | Addition or replacement of a device which is an integrated part of the primary packaging | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 52.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.IV.1 · Changes to a device co-packaged with the medicinal product or referenced in the product information
| Variant | Change | Type |
|---|---|---|
| a | Addition or replacement of a co-packaged device or referenced device | Type IA(IN) |
| b | Addition, replacement or other changes of a co-packaged or referenced device that may have a significant impact to the delivery, quality, safety and/or efficacy of the medicinal product | Type II |
| c | Deletion of a co-packaged or referenced device | Type IA(IN) |
| d | Minor change for a co-packaged device or referenced device that does not impact the delivery, quality, safety and/or efficacy of the medicinal product or the usability of the device | Type IA |
Q.IV.2 · Changes to an integral medical device (part)
| Variant | Change | Type |
|---|---|---|
| a | Addition or replacement of an integral device (part) or major change to the materials and/or design and/or performance characteristics of an integral device which may have a significant impact on the delivery or the quality, safety, or efficacy of the medicinal product | Type II |
| b | Addition or replacement of an integral device (part) which does not have a significant impact on the performance, delivery, quality, safety or efficacy of the medicinal product | Type IB |
| c | Deletion of an integral medical device (part) that does not lead to the complete deletion of a strength or pharmaceutical form | Type IA(IN) |
| d | Change of a material of a device (part) not in contact with the medicinal product | Type IA |
| e | Change of a material of a device (part) in contact with the medicinal product that does not have a significant impact on the performance, safety, quality or efficacy of the medicinal product and does not contain materials of human or animal origin for which assessment is required of viral safety data or TSE risk | Type IB |
| f | Addition or replacement of a supplier/manufacturer of an existing device (part) | Type IA |
| g | Addition or replacement of a site responsible for sterilisation of the device (part) and/or change to the sterilisation process of the device (part) when supplied as sterile | Type IB |
| h | Other minor change to an integral device (part) | Type IA |
Note: Q.IV.1 covers devices co-packaged with or referenced by the product; a device integral to the primary packaging falls under Q.IV.2.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §IX.B.3 (fn 20), §IX.C.1.a, Glossary 'Package' (by analogy) · 21 CFR 314.70(b)(2)(vi), (d)(2)(ix)
| Change | Category | Reference |
|---|---|---|
| Deletion of a co-packaged device where dosing instructions do not depend on it (How Supplied update only) | Annual report | 21 CFR 314.70(d)(2)(ix) |
| Add/replace a measuring device where the user measures the dose (dosing cup, oral syringe, spoon, dropper) | CBE-30 supplement | 2004 §IX.B.3 fn 20; §IX.C.1.a |
| Dose-controlling device or one integrated with the primary package (MDI valve/actuator, co-packaged spacer, pen or prefilled-syringe mechanism) | Prior approval supplement | 21 CFR 314.70(b)(2)(vi); 2004 §IX.B.3 |
| Non-certified device for veterinary products | No US equivalent |
Note: Co-packaged devices are classified like container closure components (Glossary 'Package'); a component is dose-controlling only when the system, not a person, meters the dose (§IX fn 20). Device certification does not lower the category. Combination products also fall under 21 CFR part 4; dosing-instruction changes follow the labeling categories. Veterinary products fall under FDA CVM rules (21 CFR 514.8).
Other items in II.5 Drug containing medical device
- 53 · Change in specification parameters and/or limits of a measuring or administration device for veterinary medicinal products.
- 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.