Last week, a beauty salon owner added me on WeChat and immediately asked: "How much does it cost at minimum to make medical device-grade medical dressings? I've seen quotes of over 100,000 RMB and some saying several hundred thousand—which is true?"
This question is very common. Today, I'll break down all the cost items for beauty salons making medical device-grade medical dressings, so owners who want to enter the market have a clear picture.
First, clarify: Medical device-grade medical dressings are not something you can just decide to make
Before making medical device-grade products, there is a threshold to clarify: not all OEM factories can do it.
In medical aesthetics skincare OEM, there is a big difference between medical device-grade and cosmetic-grade. Cosmetic-grade filing is relatively simple; an OEM factory with a cosmetics production license can take it on. Medical device-grade requires the OEM factory to have a medical device production license, and the registration certificate is applied for jointly by the OEM factory and the client.
If the OEM factory does not have a Class II medical device production license, your medical device-grade product cannot even be registered—you can only watch others do it.
This threshold comes first; only then does discussing costs make sense.
Cost item breakdown
For a beauty salon making medical device-grade medical dressings, the main upfront costs are these:
1. Registration fees
This is the big one.
For Class II medical device registration, the main costs include:
Testing fees: Sending to testing institutions for biocompatibility testing (cytotoxicity, skin irritation, sensitization, etc.), physicochemical indicator testing (appearance, pH value, content determination, etc.), and microbiological testing. Overall, about 30,000-80,000 RMB.
Registration agency service fees: If the OEM factory has a registration team, this cost can be negotiated very low. Third-party registration agencies on the market typically charge 50,000-150,000 RMB separately. If the OEM factory provides a packaged service, most of this can be saved.
Official fees: Class II medical device registration review is currently free, but changes, renewals, and other processes involve some official fees.
Overall: Registration-related costs are approximately 50,000-150,000 RMB, depending on product complexity and the OEM factory's registration support services.
2. Formula and sampling fees
Formula selection: If using the OEM factory's mature formula (mature formula library + library), this part is generally not charged separately and is included in the OEM service. If a completely new custom formula is required, formula development fees apply, ranging from 50,000-200,000 RMB.
Sampling fees: Generally 1-2 rounds of sampling, each round 500-3,000 RMB. A few products with complex formulas may require 3-5 rounds.
3. Packaging material costs
The packaging combination for medical dressings is generally: non-woven fabric + aluminum foil bag + outer box + instruction leaflet + carton.
First batch packaging materials: Depends on specifications and materials.
- Aluminum foil bag (25 pairs/pack): 1-3 RMB/pair
- Outer box: 2-5 RMB/piece
- Instruction leaflet: 0.2-0.5 RMB/sheet
- Carton: 1-3 RMB/piece
First batch packaging for 20,000 pairs: approximately 60,000-120,000 RMB.
Packaging price differences mainly lie in materials (ordinary aluminum foil vs. aluminized vs. matte film), printing process (single color vs. multi-color vs. UV), and degree of customization (public mold vs. private mold). It is recommended to choose public mold packaging for the first batch to control costs.
4. Production OEM fees
OEM fees are calculated as "processing fees" and do not include raw materials.
Medical dressing OEM fees: 0.5-2 RMB/pair (depending on specifications, weight, process complexity)
OEM fees for 20,000 pairs: 10,000-40,000 RMB.
5. Raw material costs
Raw materials for medical dressings include: non-woven fabric substrate, essence liquid raw materials (recombinant collagen, trehalose, purified water, etc.), preservatives, etc.
Raw material cost: 0.5-3 RMB/pair (depending on formula complexity)
Raw material cost for 20,000 pairs: 10,000-60,000 RMB.
6. Other costs
Label design fee: 5,000-20,000 RMB (depending on design requirements)
Testing instrument calibration, filing-related miscellaneous fees: 5,000-10,000 RMB
Store materials, employee training, first batch distribution: These are post-launch costs, ranging from 30,000-100,000 RMB depending on scale.
Total account
Adding up all the above items, the cost for a beauty salon to make medical device-grade medical dressings from project initiation to first batch launch is approximately:
| Cost item | Amount (10,000 RMB) |
|---|---|
| Registration-related | 5-15 |
| Formula sampling | 0.5-3 |
| First batch packaging (20,000 pairs) | 6-12 |
| OEM fees (20,000 pairs) | 1-4 |
| Raw material costs (20,000 pairs) | 1-6 |
| Label design | 0.5-2 |
| Other miscellaneous fees | 0.5-2 |
| Total | Approximately 15-45 million RMB |
Minimum configuration: around 150,000 RMB (self-supplied raw materials, using mature formula, public mold packaging, starting with 20,000 pairs)
Standard configuration: 250,000-300,000 RMB (including packaging design, formula fine-tuning, 20,000-30,000 pair order)
High configuration: 400,000-500,000 RMB (including custom formula, private mold packaging, 50,000+ pair order)
Note: The above does not include post-launch costs such as store operations, employee training, and marketing promotion.
Time cost must also be calculated
Money is one aspect, but time cost must be calculated even more clearly.
Medical device-grade registration cycle: 6-12 months.
During this period, you cannot sell medical device-grade products, but the normal operation of the beauty salon is not affected. You can first sell cosmetic-grade products as a transition, or accumulate private domain customers first, and launch after the registration certificate is obtained.
Packaging sampling to production: 30-45 days.
First batch mass production: 7-15 days delivery.
Adding up the entire cycle, from project initiation to product launch is approximately 8-14 months.
Several practical money-saving tips
First, use mature formulas; don't force self-developed formulas. R&D fees for self-developed formulas can easily be hundreds of thousands; mature formulas are free (included in OEM fees). Get the model running first, and consider upgrading the formula after making money.
Second, start with public mold packaging. Private mold packaging has high minimum order quantities and expensive mold opening fees. For a 20,000 pair order, public molds are completely sufficient, saving tens of thousands in mold opening fees.
Third, don't be greedy with the first order quantity. 20,000 or 30,000 pairs is enough to cover 3-6 months of use. Replenish after selling out; don't be tempted by "large order discounts" to hold too much inventory.
Fourth, find an OEM factory with registration services. Third-party registration agency fees are 50,000-150,000 RMB; OEM factory packaged services can save a large portion. Weitai Group has experience with over 110 Class II medical device registrations and filings, and registration services can be negotiated very low.
Fifth, operate private domain before the registration certificate is obtained. During the registration period, there are no products to sell, but you can first direct customers to private domain and accumulate fans. When the product launches, directly push to thousands of potential customers, and the first batch of orders will be digested.
How to calculate input-output ratio
An investment of 150,000-450,000 RMB sounds like a lot. But calculate the return:
- 20,000 pairs of medical dressings, factory price 1.5-3 RMB/pair, retail price 8-15 RMB/pair
- Sell all: sales revenue 160,000-300,000 RMB, gross profit approximately 100,000-200,000 RMB
- From the second batch, no registration fees are invested, only production costs, and gross profit can reach over 60%
- Repeat customers continue to generate repeat purchases, with a repurchase cycle of 2-3 months
According to data estimates, the first batch of goods is mainly used to get the channel running + accumulate customers, and from the second batch, it enters a positive cycle. Recovering all upfront investment in 8-12 months is a relatively common pace.
Beauty salon owners doing this should not only calculate the first account but calculate the 18-month account.
Who is suitable, who is not recommended
Suitable:
- Regional beauty salon chains with 10+ directly operated stores
- Private domain customer base of 3000+ people
- Owner has clear product thinking and can accept a 6-12 month return cycle
- Financially able to withstand 150,000-450,000 RMB upfront investment
Not recommended:
- Single store or beauty salons with fewer than 3 stores (input-output not cost-effective)
- Stores without private domain foundation, relying purely on natural traffic
- Mindset of wanting "quick payback" (medical device-grade is a slow business)
- Financially tight, wanting to do this through loans (too risky)
One last word
Making medical device-grade products is not a small business, but it's not an astronomical business either. An investment of 150,000-450,000 RMB is within the decision-making scope for a beauty salon owner with 3-5 years of accumulation.
The key is: find the right OEM factory, control the first batch investment, and prepare the private domain well during the registration period.
If these three points are done well, the rest is a matter of time and execution.
If you have OEM/ODM needs, welcome to inquire. Weitai Group has focused on medical dressings and medical device-grade OEM for 14 years, with a mature formula library + mature formulas, over 110 Class II medical device registration and filing experiences, four factories with 100,000㎡ capacity, providing beauty salon clients with full-chain support from formula selection to registration application to mass production delivery.
