Manufacturing or importing a medical device?

A medical device business license or item registration in Korea isn't a one-time filing — under Article 49 of the Medical Devices Act, every licensed, certified, or reported item must go through a periodic item renewal every 5 years to keep its safety and efficacy review current. Miss the renewal window, and the license or reporting effect can lapse — even for a device that's been on the market for years. And for products that look almost too simple to need any of this — a wrist brace, a snoring band, a nasal dilator — registering as a Class 1 medical device instead of selling as a regular consumer good is often the single biggest lever available for both legal marketing claims and pricing power.

The 5-year renewal window and exemptions

• Application window: 270 to 180 days before the current license/certification/reporting period expires — processing itself takes up to 180 days, so the filing window and processing time nearly overlap
• Who's exempt: export-only production, and conditionally-licensed/certified/reported items — everything else, including a self-reported Class 1 item, is subject to renewal
• The 5 review criteria: no material safety/efficacy problem; complete and honest documentation; actual production or import track record during the prior period; compliance with medical device law; and any additional standard the Ministry of Food and Drug Safety (식약처) has separately announced (e.g. adverse-event data, re-evaluation results)

Import's two parallel tracks

Importing a device requires both an import business license (수입업 허가) and item reporting (품목신고), pursued together rather than sequentially:

• Import business license: filed with the regional Ministry of Food and Drug Safety office covering the business's location; statutory processing is 25 business days (longer if documentation needs supplementing) — a timeline that needs to be built into any hospital-delivery schedule
• Overseas manufacturer registration: before goods can be imported, the overseas factory's name, address, and facility information must be pre-registered in the 식약처 system — a step distinct from, and in addition to, the item report itself
• Item classification: every device is matched to a specific 품목코드 (item code) and grade before anything else — e.g. a manual gynecological exam table is A01010.05, Class 1, under the "examination and surgical tables" mid-category — getting this wrong at the outset cascades into the wrong filing track entirely

The quality manager requirement

Both manufacturing and import licenses require a dedicated, in-house quality manager (품질책임자) meeting statutory qualifications — a bachelor's degree in a natural-science/engineering field or an equivalent professional license — appointed and registered before the business license is granted. This is a mandatory hire, not paperwork, and is easy to underestimate when planning a small-scale launch.

The real business case for Class 1 registration

Products with almost no inherent risk — a bite guard, a nasal dilator, a wrist brace, a compression band — don't need registration to be sold at all; they can be sold as ordinary consumer goods (공산품). But registering them as a Class 1 medical device changes what's legally possible:

• Medical marketing claims become legal: a 공산품 listing that uses words like "치료" (treats), "완화" (relieves), or "혈액순환 개선" (improves circulation) is immediately exposed to false-advertising enforcement and criminal liability; the identical claim on a registered medical device is a lawful description of its approved purpose
• Premium pricing becomes credible: consumers pay a multiple more for a product carrying an official 식약처 의료기기 registration than for the same physical item sold as a commodity good, because the registration itself functions as a trust signal
• B2B and institutional procurement opens up: hospital and public-institution bidding requires the manufacturing/import license and item report as submission documents — a 공산품 seller can't even enter the bid. Distributors also prefer officially registered products to protect their margin and avoid legal exposure, and only registered medical device makers can market at medical academic societies and trade shows like KIMES

What medical device licensing covers

• Manufacturing and import business licensing/reporting, graded by device class (1st through 4th grade)
• Item registration and reporting for individual devices — from Class 1 self-reported items to higher-grade certified items, including item-code and grade classification
• The mandatory 5-year item renewal filing under Medical Devices Act Article 49
• Quality manager appointment and registration, a prerequisite for the business license itself
• Overseas manufacturer registration for import filings
• RA (regulatory affairs) qualification and exam guidance for staff handling the filings

What we handle

• Confirming the correct device classification, item code, and licensing/reporting pathway before filing
• Preparing and submitting manufacturing/import business license or reporting applications, including quality manager appointment
• Overseas manufacturer pre-registration for import filings
• Item registration filings, including the required technical and safety documentation
• Tracking renewal deadlines and filing the 5-year item renewal within the 270–180 day window before the license or reporting effect lapses

How the process works

1. We confirm the device's item code, grade, and which license or reporting route applies — separately for domestic manufacturing versus import.
2. We prepare and file the business license/reporting (including quality manager registration and, for imports, overseas manufacturer registration) and the item registration together.
3. We track the item's 5-year renewal deadline and file the renewal application within the statutory window before it lapses.

Who typically needs this

Medical device manufacturers and importers opening a new business, companies adding a new item to an existing license, sellers of low-risk consumer-adjacent products (braces, bands, sleep aids) weighing Class 1 registration for marketing and pricing advantages, and any business with a device nearing its 5-year renewal deadline.

Common mistakes

• Missing the item renewal deadline, which can cause the license or reporting effect to lapse even for a device already on the market
• Applying for renewal outside the 270–180 day window
• Assuming export-only production is exempt from renewal without confirming the specific exemption criteria, or missing that conditionally-licensed items are also exempt
• Treating a Class 1 import as a light formality — misclassifying the item code, skipping overseas manufacturer registration, or not budgeting the 25-business-day import license processing time into a delivery schedule
• Filing item registration before confirming the manufacturing/import business license and quality manager appointment are in place
• Selling a low-risk product as an ordinary consumer good and using medical-sounding marketing language on it, which is false-advertising exposure rather than something registration would have made legal

Timeline

Business licensing and item registration timelines vary by device class; import business licensing has a statutory 25-business-day processing time. The 5-year item renewal must be filed within the 270–180 day window before expiry, with up to 180 days for processing.

Need a factory registered for production instead? See our factory registration service.