BUTTER-C
Medical device contract manufacturing
Many gels, creams and sprays look like cosmetics but are regulated as medical devices because their intended use is different. This page helps you determine which category your product falls into before planning, and how Butter-C works with you to develop it.
Cosmetic, medical device or drug
All three can come in the same gel tube, yet their dossiers, manufacturing requirements and claim wording differ. The dividing line is intended use and primary mode of action.
| Category | Primary mode of action / purpose | Market dossier |
|---|---|---|
| Cosmetic | Cleansing, perfuming, changing appearance, correcting body odor, protecting or keeping the body in good condition. | Cosmetic product notification and Product Information File (PIF), under Circular 06/2011/TT-BYT. |
| Medical device | Achieves its principal purpose by physical or mechanical means — film forming, lubrication, moisturizing, rinsing — not by pharmacological, immunological or metabolic means. | Declaration of applicable standards (classes A, B) or marketing authorization (classes C, D), under Decree 98/2021/ND-CP. |
| Drug | Principal action is pharmacological. | Under drug regulations. |
This boundary has three practical consequences:
- When an active pharmaceutical ingredient such as a corticosteroid, an antibiotic or a local anesthetic is added with a principal role, the product becomes a drug, no longer a medical device or a cosmetic.
- A product containing a pharmaceutical substance in a supporting role is usually placed in a higher risk class under the classification rules.
- An intimate-area gel can be a cosmetic (external, moisturizing) or a medical device (lubricating, moisturizing the mucosa) depending on the declared intended use — compare the intimate moisturizing gel with the feminine gel pen.
How claims are worded
For medical devices, claims are tied to the product’s physical mechanism: “forms a protective film”, “moisturizes”, “lubricates”, “mechanical cleansing”, “soothes the feeling of dryness”, “helps reduce discomfort”. Drug-like wording — promises of complete or permanent results, or of acting on microorganisms on the body — exceeds the scope of the dossier and can change the classification.
The intended use stated on the label is the basis for classification, so Butter-C reviews the wording on the label and leaflet while the formula is being developed.
Classes A, B, C, D
Under Decree 98/2021/ND-CP on medical device management (as amended and supplemented by Decree 07/2023/ND-CP), medical devices are divided into four classes, A, B, C and D, in order of increasing risk; class A carries low risk.
| Class | Procedure | Outcome |
|---|---|---|
| A, B | Declaration of applicable standards | Declaration number |
| C, D | Marketing authorization | Registration number |
Classification is based on the classification rules and the intended use declared by the product owner, and is carried out by a qualified person or organization. Formats such as lubricant gel, ultrasound gel or seawater nasal spray are usually placed in class A or B depending on intended use, contact duration and site of use (skin or mucosa), but the official classification must follow the rules. A product containing nano silver with a claimed effect on bacteria is usually not class A and may require marketing authorization.
Manufacturing requirements and quality
A medical device manufacturing facility must declare that it meets the manufacturing requirements. For the quality management system, the industry commonly refers to ISO 13485; for safety in contact with the body, biocompatibility assessment commonly applies the ISO 10993 series, for example cytotoxicity, irritation and sensitization testing.
On the technical side, Butter-C pharmacists develop the formula and run stability and packaging compatibility testing on the locked sample; finished batches are tested at a GLP / ISO 17025-accredited laboratory, with retained samples and batch records kept. Packaging is part of the product: single-dose applicators, one-way valve or bag-on-valve sprays to limit back-contamination. Classification, the declaration dossier and manufacturing requirements are discussed separately for each project.
Formats we develop
Each format has its own technical page; the whole group is listed in the medical device catalog.
| Product | Primary mechanism / note |
|---|---|
| Ultrasound gel | Bubble-free conductive water gel. |
| Feminine gel pen | Single-dose pen-format gel: moisturizes, lubricates, forms a film and helps maintain a balanced pH environment. |
| Nano silver gel & cream | The regulatory route must be chosen from the start. |
| Multi-purpose barrier cream | Forms a protective film, moisturizes and helps soothe itching and stinging caused by dryness or friction. |
| Personal lubricant gel | Water- or silicone-based; latex condom compatibility must be verified. |
| Seawater nasal spray | Mechanical rinsing and moisturizing of the nasal mucosa; valve design limits back-contamination. |
| Throat spray | Forms a protective film on the throat mucosa and soothes the feeling of dryness and irritation. |
| Mouth ulcer protective gel | Mucoadhesive gel that covers the ulcer with a film, helping reduce discomfort when eating and drinking. |
| Silicone scar gel | Semi-permeable silicone film that keeps the scar area hydrated; for use on skin where the wound has fully closed. |
How a project runs
- Discussing intended use: where, for whom and for how long.
- Choosing the regulatory route: medical device, cosmetic or drug; discussing classification under the rules.
- Developing the formula, sending samples and adjusting.
- Stability and packaging compatibility testing on the locked sample.
- Label design according to the mandatory content for medical devices and the intended use in the dossier — see packaging design and printing.
- Production, batch testing and handover.
See also the 8-step manufacturing process (in Vietnamese) and cosmetic manufacturing.
Frequently asked questions
Is my product a cosmetic or a medical device?
It depends on the declared intended use and the product’s primary mode of action. Butter-C discusses this with you from the start of the project; the official classification is carried out by a qualified person or organization under the classification rules.
Does Butter-C guarantee a declaration or registration number?
No. The outcome of the procedure depends on the dossier and the regulatory authority. Classification, the declaration dossier and manufacturing requirements are discussed separately for each project.
Can a pharmaceutical substance be added to the gel to make it more effective?
When a pharmaceutical substance plays the principal role, the product becomes a drug; in a supporting role, the product is usually placed in a higher risk class. Butter-C favors formulas that achieve their purpose by physical means.
Which route should a nano silver gel follow?
There are three routes: medical device (classified under the rules; when silver is claimed to act on bacteria, the product is usually not class A and may require marketing authorization), cosmetic (silver only within permitted limits and no claimed effect on bacteria on the skin), or drug. The route must be chosen before formula development.
Is a medical device label different from a cosmetic label?
Yes. A medical device label follows the mandatory content for this category and the intended use in the dossier, rather than reusing a cosmetic label template.
This summary is for reference and does not replace legal advice; please check the regulations in force when placing the product on the market.