Breast Pumps Are Medical Devices, Manual Ones Included — Why 442 Resale Listings Got Flagged

Key takeaway — Breast pumps are medical devices even in their manual, hand-operated form. Appendix 1 of the "Regulation on Medical Device Items and Class-by-Item Designation" classifies the manual pump as A39060.01, Class 1, and the electric pump as A39070.01, Class 2. And this isn't only a new-product issue — in August 2021, MFDS found 442 cases of unlicensed medical device sales and advertising on resale platforms, breast pumps included, and blocked the listings; a January 2024 report then found sellers evading item-name search filters by listing model numbers instead. Compiled as of September 2026, based on the primary text of Appendix 1 and the related reporting.

Breast pumps split into two classes

"It's hand-operated — surely that doesn't rise to medical device territory," is an easy assumption. Appendix 1 draws the line clearly anyway.

The manual breast pump is A39060.01, Class 1. The electric breast pump is A39070.01, Class 2.

Different class, different procedure. The manual type goes through notification with no review; the electric type requires certification with technical-document review. The difference between the two is covered in the Procedure Overview.

If you carry both manual and electric pumps under one brand, prepare both procedures separately. Clearing notification for one doesn't clear certification for the other.

What sellers of new units should check

If you handle the manual type, start with the Class 1 notification procedure — a statutory processing period of 5 days, typically 2–4 weeks in practice.

If you handle the electric type, you need Class 2 certification. Testing fees and review-agency fees are added as separate actual costs, and it typically runs 3–4 months. Cost structure is covered in the Class 2 Certification Cost Guide.

If you're reselling sourced products, check the supplier's notification number (manual) or certification number (electric). A "notification number" and a "certification number" are different things — match the number type to whether the unit is manual or electric.

It doesn't stop there — resale gets flagged too

There's one more place breast pumps get flagged often: individuals reselling a used one.

Only a business registered to sell medical devices may sell them (Medical Devices Act Article 17). An unregistered individual conducting repeated, ongoing resale of a used breast pump violates this provision, punishable by up to 3 years in prison or a fine of up to 30 million won.

This isn't hypothetical. In August 2021, MFDS surveyed resale platforms and found 442 cases of unlicensed medical device sales and advertising.

By item: 254 for wound dressings, 142 for medical suction devices, 39 for breast pumps, and 7 for contact lenses. By platform: Junggonara 315, Bunjang 107, Hello Market 20; no violating posts were confirmed on Danggeun Market. MFDS blocked access to the flagged listings.

Not showing up in search doesn't make it fine

A January 2024 report covered how sellers were adapting.

Platforms block searches for item names like "breast pump" or "nebulizer." But sellers were evading that filter by listing model numbers instead of the item name — search by model number, and dozens of used listings surface as-is.

Not showing up in a filtered search doesn't make the sale legal. MFDS runs this kind of enforcement every year, and the method could well expand beyond keyword blocking.

Worth knowing if you're buying used, too

There's risk on the buying side, too. MFDS has flagged hygiene concerns and quality-variance risk in used units.

A product with parts that contact the body directly — bottles, tubing — carries a hygiene risk in itself when you can't verify how it was cleaned and sterilized.

Common mistakes

• Assuming the manual type is low-risk enough to skip notification
• Preparing the electric type under the same notification procedure as the manual type
• A resale seller not checking the supplier's notification or certification number
• An individual reselling used pumps repeatedly, assuming it doesn't require a sales-business registration
• Assuming that listing by model number to dodge an item-name filter makes the sale fine

Before you proceed

• Confirm whether the unit you're handling is manual or electric
• If manual, confirm the Class 1 notification procedure; if electric, confirm Class 2 certification
• If reselling sourced products, match the supplier's notification or certification number to the unit type
• If you're personally reselling used units repeatedly, confirm whether sales-business registration is required
• Confirm the listing or packaging carries medical device labeling and a notification/certification number

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Because breast pumps read as ordinary baby gear, they're one of the items most easily waved through — on both the approval side and the resale-regulation side. Whether you're handling new units or considering a resale, tell us whether it's manual or electric and how you plan to sell it, and we'll walk you through the procedure in a free pre-review.

Sources: Breast pump classifications (manual A39060.01, Class 1; electric A39070.01, Class 2) are based on the primary text of Appendix 1 of the "Regulation on Medical Device Items and Class-by-Item Designation" (MFDS Notice No. 2026-18, effective March 9, 2026), confirmed directly via the National Law Information Center PDF. Enforcement case of 442 unlicensed medical device sales/advertising listings on resale platforms (reported August 13, 2021, Uibak Sinmun). Model-number filter-evasion case (reported January 5, 2024, Newsis). Sales-business registration duty and penalties are based on Medical Devices Act Articles 17 and 52. Item classifications and fees are subject to change with notice revisions, and the classification and class of an individual product can vary based on its intended use and operating principle.