GGuidelines

Medical device regulatory guidelines.

Korean approval, certification, and notification procedures — with the governing rules, standards, and submission documents — organized for practice.

Testing data2026.10.19Reviewing Overseas Clinical Evidence for Korea: Does It Support the Proposed Intended Use?An overseas approval or publication is not the same as evidence supporting the Korean application. Compare study devices, populations, endpoints and use environments, then document applicability and unresolved gaps.
Testing data2026.10.18Medical Device Material Changes: When Can Existing Biological Evidence Be Reused?The same silicone or resin name does not establish unchanged biological safety. Compare supplier, formulation, processing, cleaning and sterilization against body contact before deciding what existing evidence remains applicable.
GMP2026.10.17Calibration Records for Medical Device Inspection Equipment: Scope Before ScheduleFiling calibration certificates does not complete equipment control. Link each instrument to product decisions, confirm the relevant range and acceptance criteria, and assess earlier inspections when results are out of tolerance.
By device type2026.10.16Blood Glucose Meter Imports into Korea: Separate Self-Testing, Professional Use and Strip CombinationsA strip-based blood glucose system cannot be reviewed through the meter alone. Connect users, specimens, meter and strip models, calibration, quality controls and storage with the proposed IVD scope.
By device type2026.10.15Wound Dressing Classification in Korea: Start with Purpose, Contact and ClaimsFoam, film and hydrogel names do not determine a dressing's Korean class or evidence requirements. Define the wound, contact conditions, action and claimed effects before selecting a regulatory category.
By device type2026.10.14Hearing Aid Imports into Korea: Review the Receiver, Earpiece and Fitting Software TogetherBrand and appearance do not define a hearing aid family. Connect hearing-assistance purpose, receiver and earpiece combinations, acoustic evidence, fitting software and Korean instructions before import.
By device type2026.10.13Pulse Oximeter Import Checklist for Korea: Sensors, Patients and Measurement ConditionsA finger-clip appearance does not determine the Korean import route or evidence needed. Define medical purpose, patient population, sensor combinations and measurement conditions, then check the supporting performance evidence.
Testing data2026.10.12Home-Use Medical Device Instructions: Review Use Errors Before TranslationTranslating professional instructions into Korean does not establish suitability for home use. Connect preparation, operation, result interpretation, cleaning and storage errors with instructions and usability evidence.
Import & customs2026.10.11Importing Medical Device Accessories and Consumables: What Does the Main Device Registration Cover?Products used with a registered main device are not automatically within its registration. Connect function, registered configuration, separate packaging and sales, and compatibility evidence before importing replacements.
By procedure2026.10.10Adding a Medical Device Model in Korea: Build a Product Family ComparisonA similar model name does not establish that a new device belongs within an existing Korean registration. Compare intended use, design, configuration and performance, then separate the regulatory change decision from the reuse of existing evidence.
GMP2026.10.09KGMP CAPA Responses: Connect Causes, Actions and Effectiveness With EvidenceA revised procedure and training attendance alone may not show that a finding’s cause was resolved. Link observations, impact, investigation and recurrence-prevention evidence in the response.
GMP2026.10.08Medical-Device OEM Quality Agreements: Agree Change Notices and Data Access FirstPrice and delivery terms do not establish an audit or complaint-investigation process. Define evidence, approvals, changes and post-market cooperation between the commissioning company and manufacturer.
Testing data2026.10.07Usability Validation Planning: Select Participants and Scenarios From Use RiskUsability validation is more than a satisfaction survey or demonstration. Link users, environments and critical tasks to risk, and plan moderator intervention, error investigation and design follow-up.
Testing data2026.10.06Medical-Device EMC Test Configuration: Define Cables, Modes and Performance FirstAn EMC report applies to its tested configuration and observation criteria. Align the intended environment, connections, modes, monitoring and modification records before laboratory work.
Testing data2026.10.05IEC 60601 Electrical-Safety Test Planning: Agree the Scope Before Sending SamplesSending one finished unit is not a complete test plan. Align standards, basic safety, essential performance, power and accessory combinations, and design evidence before testing starts.
Testing data2026.10.04Medical-Device Shelf-Life Evidence: Plan Aging and Product Performance TogetherPackaging aging alone rarely answers every shelf-life question. Connect functional performance, material change, sterile barriers and storage conditions to the duration claimed.
Testing data2026.10.03Sterile Packaging Validation: Connect Package Tests With Sealing-Process EvidenceProtection must continue after sterilization until use. Connect material selection, sealing, distribution, aging and aseptic opening within one evidence plan.
GMP2026.10.02Planning Medical-Device Process Validation Before IQ, OQ and PQSeparate processes adequately verified by inspection from those needing validation, then build evidence for installation, operating limits and actual production variation.
Testing data2026.10.01IEC 62304 Documentation: Trace Requirements Through to the Released BuildSoftware evidence works when requirements, risk controls, tests, unresolved anomalies and release records identify the same functions and versions. Build those links before expanding the document set.
By procedure2026.09.30A Startup’s First Korean Device Submission: Decisions to Make Before Paying for TestsA first submission depends on when the product and manufacturing model are defined. Map the decisions, evidence owners and entry conditions needed at each stage of development and regulatory preparation.
By device type2026.09.29Masks, Hand Disinfectants and Lens Solutions: Checking Korea’s Quasi-Drug BoundarySimilar product names can lead to different Korean regulatory routes. Use masks, hand disinfectants and contact-lens care products to build a classification dossier around intended use and the object being treated.
By device type2026.09.28Is a Wearable a Medical Device in Korea? Review Intended Use, App Functions and RiskA watch or patch is a form factor, not a regulatory class. Using the MFDS February 2026 wellness guidance, map the product's claims, sensor, app, analysis and user action before deciding its Korean regulatory route.
By procedure2026.09.28Korean Medical Device Certificates — Issue, Lookup, Reissue, Changes and TransferA business licence, item registration and KGMP certificate serve different purposes. Learn how to identify the requested document, maintain its attachments and history, and distinguish replacement of a lost certificate from changes or succession to registration status.
Regulatory updates2026.09.28Korea Adverse Event Reporting Update — Quarterly Product Problems Versus Expedited ReportsThe August proposal became MFDS Notification 2026-67, effective 22 September 2026. Separate eligible product problems from serious events before changing your reporting calendar, and check which open cases qualify under the transition clause.
By procedure2026.09.25Medical Device Registration Fees and Statutory Deadlines in Korea — One-Page Table for Classes 1–4, Business Licences, KGMP, and RenewalHow much goes to the government, and how many days does the law allow? The scattered numbers gathered on one page — item notification, certification, and licence fees by class, manufacturing and import business licence and sales notification fees, renewal fees, the statutory notice periods and the “deemed granted if no notice” rule, and the validity periods of licences and KGMP conformity. Also how a quotation splits between statutory fees, third-party costs, and consulting fees.
Import & customs2026.09.24IVD Registration and Distribution in Korea — Which Licences an Overseas IVD Manufacturer and a Korean Distributor Each NeedTo bring reagents, kits, or analyzers into Korea and sell them, who needs which licence? Since 2020 in vitro diagnostic devices have been governed first by their own statute, with everything it does not cover falling back to the Medical Devices Act. This guide separates what the overseas manufacturer must supply from what the Korean distributor must file — the import business licence and item procedures, the quality manager, the sales business notification and the self-testing exemption, certification of laboratory-developed tests, and the extra label items.
Regulatory updates2026.09.23PPWR for Exporters to the EU: Packaging and Documents to Review FirstIf you export products to the EU, packaging needs its own review alongside product certification. This guide explains the scope of PPWR, current obligations and phased application dates, and the documents to request from suppliers. It also introduces CLARE Partners' pilot consulting project for three Korean exporters.
By procedure2026.09.23Medical Device Registration in Korea for Overseas Manufacturers — the 7-Step MFDS Approval PathA product with FDA clearance or a CE certificate is reviewed from the beginning in Korea. This guide lays out, from the overseas manufacturer's side, the order in which a Korean registration actually proceeds — classification, choosing the licence holder, the dossier the manufacturer must supply, KGMP conformity, the MFDS item review, Korean labeling, and post-market duties — and where your existing overseas approvals fit in.
Import & customs2026.09.22Korea License Holder (KLH) for Medical Devices — Who Holds Your MFDS Licence, and the ICC StructureIn Korea the import licence for a medical device is issued to the importer, not to the manufacturer. An overseas manufacturer therefore needs a company in Korea to hold the licence before anything else. This guide compares the three structures — distributor as importer, a Korean subsidiary, and an independent licence holder (ICC) — by who ends up owning the registration, what happens when the agreement ends, and which clauses belong in the contract from day one.
By procedure2026.09.17What Begins After Approval — Reporting, Records, Recall and Re-evaluation on One PageThe certificate is not the end but the start of obligations. Adverse events are reported immediately, foreign matter without delay, supply records and standard codes periodically. Tracking records, recall, re-evaluation, post-market surveillance and renewal each run on their own axis. Eight branches, gathered on one page from the text.
By procedure2026.09.16Korea's Medical Device Distribution Quality Standard — What Follows the Distributor NotificationThe distributor notification opens the door; Annex 6 of the Enforcement Rule is what comes next. Storage facilities, a control manager, incoming and outgoing checks, three registers and twelve hours of annual training all sit there. An online-only seller holding no storage site is exempt from a substantial part of it. Set out from the annex.
By device type2026.09.15Pregnancy Test Kits Are IVD Medical Devices — Sales Exemption and Import Procedure Are Separate MattersA self-testing pregnancy test kit is reviewed under the IVD product classification as either the personal pregnancy hormone test strip (J14030.01, Class 2) or, where a reader device is used, the personal pregnancy hormone test device (J04030.01, Class 2). The Regulation on IVD Medical Device Approval, Notification, and Review exempts both items from the sales business notification, but that does not remove the import business license under Article 11 of the IVD Medical Devices Act or the per-item import procedure. This guide covers the difference between consumer-use and professional-use requirements, detection performance data, and advertising wording to watch.
GMP2026.09.15Korea's Three MDSAP Audit Guidelines — A Door That Opens Both WaysOn 28 August 2026 the MFDS issued three guidelines on responding to an MDSAP audit. They are framed as support for Korean manufacturers going abroad, yet the same MDSAP certificate also shortens the domestic KGMP procedure. This guide sets out the five-country structure, why those three product types were chosen, and what actually changes at home.
By device type2026.09.15Is a Brace a Medical Device? The Item Called 'Splint' Draws the LineKnee braces, wrist braces, and back braces are not sorted into medical devices by their material or by the word 'medical' in the name — the deciding factor is whether the product actually has a support function. The MFDS product classification notification defines the item as the 'splint' (B05010.01, Class 1) — a device with a support function that compresses or fixes part of the body, explicitly excluding anything without a support or load-bearing function. This guide covers the test for that boundary, the Class 1 notification procedure, handling multiple size models, and advertising wording to avoid.
By procedure2026.09.14The Businesses That Are Not Distribution — Medical Device Lease and Repair Notifications in KoreaIf you have filed a distributor notification, you do not file again to lease. Repair, however, is an entirely separate notification and it demands facilities and a quality system. Servicing your own products is outside the notification requirement, and an online-only seller may use a residential building as its place of business. The boundaries of the three businesses, from the text.
By procedure2026.09.13Reselling Used Medical Devices in Korea — The Rules Turn on Where You Bought It, Not on It Being UsedThere is no separate approval for trading used medical devices. Instead the Enforcement Rule restricts who you may buy from, and attaches inspection and an inspection tag to devices bought from a medical institution. Buying from a private individual falls outside the permitted routes, and a device without an inspection tag may not even be displayed. Set out from the text.
By procedure2026.09.12Do Medical Devices Need KC and Radio Certification in Korea — Electrical Safety Is Exempt, Wireless Is the ForkA Korean medical device approval exempts the electrical-appliance KC procedures. Radio certification is different: the Enforcement Decree annex lists the exemption as covering registration and self-declaration only, and conformity certification is not on that line. For a product with Bluetooth or Wi-Fi, that single line decides the schedule.
By device type2026.09.11Digital Therapeutics Approval in Korea — A Name Absent from the Statute, Present in a Product CodeThe Digital Medical Products Act contains no term for digital therapeutics. Where the name does appear in a normative document is a single cell in the product code of the classification and grading notification. That one cell decides the class, the approval track, and whether clinical data can be waived. This guide fixes the coordinates from the text.
Regulatory updates2026.09.10Exemption from Post-Market Surveillance for Rare Devices — The Enforcement Rule of 1 July and the Draft NotificationPost-market surveillance is a four-to-seven-year obligation attached to the manufacturing approval of newly developed and rare medical devices. An amendment to the Enforcement Rule that took effect on 1 July 2026 created the basis for exemption, and on 6 August the MFDS pre-announced a notification amendment filling in what that rule delegated (Public Notice No. 2026-393). This guide sets out what is exempt and what must be submitted, from the text.
By procedure2026.09.10New Health Technology Assessment in Korea — Approved by the MFDS, Still Not Usable in HospitalsMFDS approval answers whether the product may be sold. Whether a hospital may charge for the procedure that uses it is decided by the Ministry of Health and Welfare through new health technology assessment. The two run under different ministries and different statutes. This guide sets out what is assessed, how the deferral scheme works, the 90-day and 250-day deadlines, and the consent and monthly reporting duties that attach during a deferral.
By device type2026.09.10Breast Pumps Are Medical Devices, Manual Ones Included — Why 442 Resale Listings Got FlaggedBreast pumps are medical devices in Korea, whether manual or electric. Appendix 1 of the "Regulation on Medical Device Items and Class-by-Item Designation" classifies manual pumps as A39060.01, Class 1, and electric pumps as A39070.01, Class 2. In 2021, MFDS found 442 cases of unlicensed medical device sales and advertising on resale platforms, including breast pumps, and blocked access to the listings. A 2024 report found sellers evading item-name filters by listing model numbers instead. This guide covers what sellers and individual resellers should each check.
By device type2026.09.09Thermometers Are Medical Devices — Contact and Non-Contact Alike, and Unlicensed Sellers Have Been CaughtContact-type electronic thermometers are Class 2 items ("electronic thermometer," A21010.03) requiring certification. Non-contact (infrared) thermometers are also managed as a separate medical device item. In December 2024, Korean authorities reported a real enforcement case: a company was caught manufacturing and selling over a thousand non-contact infrared thermometers assembled from imported sub-assemblies, without a manufacturing license. This guide covers the label items sellers should check and the assembly-license trap.
By procedure2026.09.09Nasal Wash Kits — Not a Toiletry Item, but a Medical Device Since 2018Nasal wash kits ("co-sejeong-gi") and the saline powder sold with them had no dedicated medical device item until a 2018 revision to the MFDS product-classification notification created "manual nasal wash kit" and "powered nasal wash kit" as new items — before that, many such products circulated like ordinary toiletries. The manual kit is confirmed as a notification (Class 1) item on products actually on the market, and the saline powder sold with it became a medical device under the same revision. This guide covers what sellers should check, plus a real advertising-violation pattern regulators have flagged.
GMP2026.09.09ISO 13485 and Korea's KGMP — What Is the Same and What Is DifferentWe are often asked whether an ISO 13485 certificate settles KGMP. The answer is: same skeleton, different procedure. Annex 2 of the KGMP notification is built on the same clause 4 to clause 8 structure as ISO 13485, but who grants recognition, the three-year validity and periodic audit, on-site inspection, and the requirements layered on by Korean law all differ. Working from the full text of the notification, this guide sets out what carries over, what must be added, and the route that only MDSAP opens.
Regulatory updates2026.09.08Korea's Medical Devices Act Amendment Bill — Document-Submission Orders and a General Corrective Order (Comments Due 14 September)On 4 August the MFDS pre-announced a bill to amend the Medical Devices Act (Public Notice No. 2026-376). Article 32 gains an express power to order device handlers to submit documents, and Article 35-2 — until now limited to expenditure-report breaches — becomes a general corrective-order provision with a duty to report compliance. Refusal becomes both a ground for administrative sanction and a criminal fine, and the corrective order reaches violations that pre-date the law. Comments close on 14 September 2026.
By procedure2026.09.04Renewing a Korean Medical Device Licence — Five Years, and a Window 270 to 180 Days OutApprovals, certifications and notifications carry a five-year validity, and the renewal application opens as a window — 270 to 180 days before expiry, not simply 'before expiry'. Knowing this early costs far less than knowing it late.
By class2026.09.04Class III and IV Devices in Korea — How Approval Differs from Class II CertificationThe last box after Class I notification and Class II certification. Moving to Class III or IV changes more than the name of the pathway — it changes the question the review asks. Here is what gets added and where the schedule stretches.
By procedure2026.09.04Medical Device Clinical Trials in Korea — When They Are Needed and What to Settle FirstA clinical trial is not a step every product goes through. What decides it is not the class but whether existing evidence can explain safety and performance. Here is the approval structure, the exceptions, and the effect on the schedule.
Testing data2026.09.04ISO 14971 Risk Management — A Warning in the Manual Is the Last ResortRisk management is not a set of documents but a process that runs through the whole of development. Risk control in particular has a fixed order of priority, and solving by warning label what could have been solved by design is itself a finding.
By procedure2026.09.04In Vitro Diagnostic Devices in Korea — Why the Medical Device Guides Do Not ApplySince 2020 in vitro diagnostics have been governed by their own statute in Korea. The basis for classification differs, and so does the name and structure of the clinical evidence. Here is what carries over, what diverges, and the order to prepare in.
By procedure2026.09.04Medical Device Advertising Review in Korea — What Is Covered and What Is ExemptThe current mechanism is not government pre-screening but self-regulatory review. Here are the six media categories that trigger it, the exemptions that let you skip it, and the less-known three-year validity with a six-month renewal deadline — set out from the statute.
Import & customs2026.09.04Sourced Abroad but Stuck at the Import Licence — Three Routes a Seller Can TakeFinding the product is rarely the hard part; the import business licence is where it stops. Here are three routes — obtain it yourself, buy from an existing importer, or place the licence with a separate holder — compared on control, requirements and risk, plus the distinction the third route hinges on.
By procedure2026.09.04Medical Device Manufacturing Licence in Korea — Company Licence and Product Approval Are SeparateThe manufacturing licence is a company-level permit granted per manufacturing site; product approval, certification and notification run at the item level. They are separate tracks, and running them in parallel is what shortens the timeline. Here is how manufacturing, importing and distribution divide, and what the licence actually examines.
By device type2026.09.04Laser Medical Devices in Korea — Laser Class and Device Class Are Two Different Systems'Class 4 laser' and 'Class III medical device' are different systems, yet they get used interchangeably. Here are the three boundaries a laser product has to clear in Korea — is it a medical device, which item class, and who is it built for — in the order you should work through them.
Testing data2026.09.04ISO 10993 Biological Evaluation — What to Settle Before You Commission TestingISO 10993-1 is not a list of tests to run — it is a requirement to evaluate within a risk management process. That makes sequence decisive: material information and contact categorisation have to be fixed before the endpoints appear, and only then does a test quotation mean anything.
Testing data2026.08.26Medical Device Usability Requirements in South Korea — Legal Basis and How to PrepareUsability is not about whether a device is pleasant to use — it is about whether the risk of use error was controlled by design. Here is the Korean legal basis, how to check whether your product is in scope, and how the file connects to risk management.
By procedure2026.08.25What Medical Device RA Actually Does in South Korea — One Year in the Regulatory CycleRA (Regulatory Affairs) is the title a company gives the role; the position Korean law actually names is the quality manager (Articles 6(7) and 6-2 of the Medical Devices Act). Here is what RA does in practice, laid out as the annual cycle of approval, change, renewal, and post-market work — plus the signals that tell you a company now needs RA, and the axis that decides what to hire in-house and what to place outside. As of August 2026.
By procedure2026.08.24Medical Device Quality Manager Requirements in South Korea — Qualifications, Duties, TrainingEvery manufacturing site and import office in Korea must appoint at least one quality manager. Here are the ten qualification routes, the concurrent-duty restriction, and the mandatory eight hours of annual training — with the exact provisions of the Enforcement Rule.
By device type2026.08.24Korean Medical Device Approval by Product Type — a Quick Guide to 16 Frequently Asked Item FamiliesFrom thermometers, nebulizers, and catheters to AI medical devices — one page mapping the name variants and decision forks for 16 frequently searched item families. One principle throughout: item classification sets the class, and the class sets the procedure.
By procedure2026.08.23Class 2 Certification Costs: Why Every Quote Is Different — How Testing and Review Fees Break DownClass 2 certification costs split into four strands: the statutory fee of KRW 130,000 (a fixed amount), review body fees at published rates, testing costs that vary by product, and the consulting fee (from ₩6.0M). Here is which strand the differences between quotes come from, how to break a quote apart before comparing, and why “guarantee” language calls for a second reading.
By procedure2026.08.21Common Reasons a Class 1 Notification Gets Rejected in KoreaA Class 1 notification skips the technical file review — but the notification requirements and the check of what you entered remain, which is why rejections and deficiency notices still happen. Here are the five patterns that come up most often in practice — item misclassification, inconsistencies between documents, intended use beyond the item definition, missing prerequisites, and missing or malformed attachments — with prevention points for each and the order to work in after a rejection.
By procedure2026.08.19Do Class 1 Devices Also Need UDI and Supply Reporting? — The Obligations That Start After NotificationA Class 1 notification certificate is not the end of your obligations — it is the start. UDI standard code marking, registration in the Integrated Medical Device Information System (Article 20, subparagraph 8 and Article 31-3 of the Medical Devices Act), and monthly supply reporting (Article 31-2): here are the three post-notification obligations sorted by who, what, and by when — plus the administrative fines for violations and how to build a monthly operating routine.
By procedure2026.08.18Using Korea's Integrated Medical Device Information System — Registration and Supply ReportingOnce the certificate is issued, the Integrated Medical Device Information System is where your team works every week. What the system covers (standard codes, integrated information registration, supply reporting), the two deadlines that matter — before shipment, and within 10 days of a change — which devices supply reporting actually applies to, its end-of-next-month cut-off, and the points where practitioners get stuck, set out against the statutes and notices in force as of August 2026.
By procedure2026.08.17Class 1 Notification: Do It Yourself or Hire an Agency? — An Honest Comparison of Time and CostFile a Class 1 notification yourself and the statutory fee is KRW 85,000; hand it to an agency and the service fee runs from ₩2.0M. We put the cost structure of both routes in the same table — plus the five points where DIY filings most often stall, the conditions under which each route makes sense, and how to switch midway.
By procedure2026.08.16Massager vs. Medical Device — Borderline Products, and Where the Consumer-Product Zone EndsMassage guns, electric massagers, and heated mats are the classic product family sitting on the boundary between consumer products and medical devices. Annex 1 of the MFDS product classification notification writes that boundary down in so many words — the definition of the medical vibrator excludes “electric massagers manufactured simply for the purpose of benefiting general health,” and the medical warmer excludes “heated electric mats used for simple warmth.” This guide sorts out which claims cross the line, and what changes once you cross it (misleading-advertising risk and the Class 2 certification track).
By procedure2026.08.15Overseas Direct Purchase and Purchasing-Agent Sales of Medical Devices — What Is Allowed and What Is NotBringing in a device to use yourself and bringing one in to sell to others are treated completely differently under Korean law. Anchored to Article 26(1) of the Medical Devices Act — which prohibits the sale and giving away of unregistered medical devices, and their import, storage, and display for the purpose of sale — this guide sorts out what is allowed and what is not in overseas direct purchase and purchasing-agent sales, and the lawful route to selling.
By procedure2026.08.12Veterinary Medical Device Registration in South Korea — It Is APQA, Not MFDSVeterinary medical devices in South Korea follow the Medical Devices Act, but through a different door: the Animal and Plant Quarantine Agency (APQA) and the Regulations on the Handling of Veterinary Pharmaceuticals, etc. This guide covers jurisdiction, the Class 1–4 system, where approval ends and notification begins, business licenses, and how it all differs from human-use devices — anchored to the regulation text in force.
By procedure2026.08.11Medical Device Labeling Requirements in Korea — What Must Appear on the Package and LabelThe container or outer casing of a medical device sold in Korea must carry the nine items prescribed by Article 20 of the Medical Devices Act — and outer packaging (Article 21), the package insert (Article 22), and Korean-language marking (Article 23) complete the set. In vitro diagnostic (IVD) devices follow their own statute with three extra container items. Here are the omissions that surface most often in reviews, the two tiers of penalties, and what to check before labels go to print.
By procedure2026.08.09A Class 1 Device That Still Needs KGMP — Sterile ProductsThe conventional wisdom that “Class 1 is exempt from KGMP” is mostly right — but what the provision waives is the “assessment,” not the “standard.” For sterile products, the sterile-workplace facility requirements and sterilization validation remain after the waiver, and when exports or a buyer demand a certificate of conformity, even Class 1 devices take the assessment voluntarily. On top of that, sterility can change the product’s class designation.
By procedure2026.08.08Class 2 Medical Device Certification in Korea, End to End — A Seller's PerspectiveA Class 2 medical device is “certified”: you prepare a technical file and pass review by a designated review body. This guide covers the cost structure that separates the KRW 130,000 statutory government fee from the out-of-pocket costs paid directly to review bodies, where the typical 3–4 months actually go, and the three stages — technical file drafting, review, certification — all from an online seller's perspective.
By procedure2026.08.07What You May and May Not Say on a Listing Page — Advertising Rules for Medical DevicesRegistering a product as a medical device does not free its advertising: claims are permitted only within the scope of the approval, certification, or notification (Article 24(2) of Korea’s Medical Devices Act). Coupang and Smart Store listing pages count as media subject to self-regulatory ad review, while ads composed solely of the approved particulars are exempt. The prohibited ad types and the prior self-regulatory review system, from an online seller’s perspective.
By procedure2026.08.07Importing Class 1 Devices from Overseas — Start with the Import Business LicenseBringing a foreign Class 1 medical device into Korea takes two filings: the company-level import business license (statutory fee KRW 144,000) and a per-product Class 1 import notification (KRW 85,000). Here is how the two procedures sequence, the quality manager and facility requirements, manufacturing-source evidence, and the link to customs clearance — laid out in the order a first import actually runs.
By procedure2026.08.05Medical Device Sales Business Notification in Korea — When It Is Required and When You Are ExemptAnyone who intends to sell medical devices as a business must, in principle, file a sales business notification with the local government having jurisdiction over the place of business (Medical Devices Act, Article 17(1)). Exemptions cover pharmacy founders and pharmaceutical wholesalers, manufacturers and importers selling to medical device handlers, and items designated by Ordinance of the Prime Minister. This guide maps the exact scope of the four exemptions, the filing procedure and fee for online sellers (KRW 10,000, or KRW 9,000 for electronic filing), and the penalties for selling without notification — all anchored to the statutory text.
By procedure2026.08.03Class 1 Medical Device Notification in Korea: The Complete Seller's GuideClass 1 medical devices are registered by an e-filed “notification” with no technical file review. The statutory fee is KRW 85,000, the statutory processing period 5 days, and the practical lead time typically 2–4 weeks. Who actually files, the step-by-step e-filing procedure, the required documents, and the costs and timelines — all laid out from an online seller's perspective.
By procedure2026.08.02Popular Products a Notification Won't Cover — Low-Frequency Stimulators and Personal Warmers Need “Certification”The functions claimed by low-frequency (EMS) massagers and electric heating pads sold everywhere online map to the personal low-frequency stimulator and the personal warmer under the MFDS product classification — both Class 2. Unlike a Class 1 notification with no review, Class 2 devices go through a technical file review as “certification” items. Here is a class cross-reference table for popular products, and the difference between notification and certification from a seller's point of view.
By procedure2026.08.01Is My Product a Medical Device? — How to Find the Product Classification and ClassWhether a product is a medical device is judged by the intended use it claims, not by its material or performance. This guide works through the four subparagraphs of the definition in Article 2 of Korea’s Medical Devices Act, then covers how to find the product classification and class in Annex 1 of the MFDS notification (No. 2026-18), how to read a classification number, borderline cases against ordinary consumer products, and the pre-review route for confirming officially with the MFDS — in order.
By procedure2026.07.23Not Everyone Gets to Say ‘Medical Device’ on Coupang — Where Consumer Products End and Medical Devices BeginUse words like ‘treatment’ or ‘medical-grade’ on a product that is not a medical device and you create a potential violation of Article 26(7) of Korea’s Medical Devices Act. From an online seller’s perspective: the boundary between consumer products and medical devices, three common misconceptions, and the legal route to those claims (Class 1 notification).
By procedure2026.07.23How to Choose a Medical Device Regulatory Consultant in Korea — 7 Criteria to CheckInstead of a list of recommended firms, this guide gives you the yardstick: seven criteria — the three-way quote split, track record proven by issued documents, staffing continuity and more — plus questions you can ask verbatim at any consultation and a comparison checklist you fill in yourself, so every firm you meet is measured against the same standard.
Regulatory updates2026.07.21Digital Medical Devices Coming Into Scope for Korean Testing Laboratories — MFDS Announces Draft Rule RevisionSouth Korea's MFDS has published a draft revision to the enforcement rule governing designated testing and inspection laboratories. Medical device laboratories would be able to test digital medical devices, and a new basis for reducing administrative sanctions would be added. Comments are open until 14 September 2026.
Regulatory updates2026.07.21Korea's KGMP Notification Splits in Two — What Changes on 1 July 2026The provisions on designating and overseeing institutions have been carved out of the Regulation on Medical Device Manufacturing and Quality Control into a separate notification, and a formal auditor qualification scheme is introduced. Based on the pre-announced drafts, no change to the audit criteria themselves is evident — this reads as a restructuring of where the rules sit and how audits are run.
Regulatory updates2026.07.21South Korea Announces Draft Revision to Digital Medical Device Review Rules — Clinical Data Waivers Extended to All Classes and All Product AreasThe MFDS has pre-announced a revision to its digital medical device review regulation. Waiver and substitution of clinical and other evaluation data — previously limited to Class II standalone software — will apply regardless of class across therapeutic, diagnostic, and screening products. The comment period closes 21 July 2026 (today is the last day).
By procedure2026.07.20Writing a Medical Device Technical File in South Korea — A Section-by-Section GuideFrom shape and structure to precautions for use — what reviewers actually look for across the seven sections of Korean technical documentation, and the drafting order that protects the cross-section consistency behind most deficiency letters.
By device type2026.07.20Standalone Software as a Medical Device (SaMD): A Guide to MFDS Approval in South KoreaAn app or program with no hardware at all can still be a regulated medical device. From the line that decides whether your software is a medical device, through the IEC 62304 document set and cybersecurity evidence, to what is different about AI software — a full map of what SaMD registration in Korea requires.
By device type2026.07.20Importing Intraoral Scanners into South Korea — A Practical Registration GuideYour Chinese-made intraoral scanner already carries a CE mark — so what has to be built again for Korea? From classification and test data to how far CE documentation actually travels and which documents you must extract from your Chinese manufacturer, here are the real bottlenecks of an import project, in order.
Testing data2026.07.20Can Overseas Test Reports Be Used for Korean Medical Device Registration?How far can the CB reports and overseas test data your manufacturer already holds carry you through Korean registration? A practitioner's view of where recognition ends, where retesting begins, and the traps that turn into deficiency letters.
By procedure2026.07.20Change Approval, Change Certification and Change Notification for Medical Devices in South KoreaRegistration is not tested the day you receive it — it is tested every day you hold it. Adding a model, switching a manufacturing site: here is what separates a change that needs review from a minor change, and what an undeclared change actually costs.
By procedure2026.07.20We Have CE Marking — Does That Cover Medical Device Registration in South Korea?CE and FDA are entirely separate from MFDS approval — there is no mutual recognition. Yet a large share of your documentation is reusable. Here is what carries over, where new testing appears, and why the order must be inventory first, gap analysis second.
By device type2026.07.20Single-Use Biopsy and Puncture Needles — South Korea Registration GuideWhy does a single needle turn into hundreds of pages of documentation? For single-use sterile devices, the review is not decided by performance but by sterilization, materials, and packaging. Here are the real bottlenecks in registering biopsy and puncture needles in South Korea.
By device type2026.07.08Ultrasonic Inhaler Approval Guide for Korea'Ultrasonic inhaler' is a name shared by home nebulizers and surgical aspirators. Which one you have completely changes the class, tests, and timeline.
By device type2026.07.08Rehabilitation Robot Registration Guide for South KoreaRehabilitation robots put mechanics, electronics, software, and clinical evidence into a single product. Classification and the clinical-data variable, a map of required testing, risk management centred on entrapment, falls, and overload, and the dual patient/therapist use scenarios — how to approach one of Korea's most complex review categories.
By procedure2026.07.08Complete Guide to Korean Medical Device Approval — Notification vs. Certification vs. ApprovalIs your product a notification, certification, or approval? Classification criteria plus a one-page comparison of procedures, timelines, and key documents for all 4 classes.
By device type2026.07.08Nebulizer Approval Guide for KoreaCompressor, ultrasonic, and mesh nebulizers — classification, review points, accessory configuration for imports, and KGMP: the practical checkpoints for inhalation therapy devices.
GMP2026.07.08KGMP Conformity Assessment Guide — Audit Types, Required Documents, Overseas Site PreparationKGMP, the rite of passage for Class 2+ devices in Korea. Audit types, the quality system document framework, and the real reasons overseas site audits delay projects.
Import & customs2026.07.08Medical Device Import Guide for South Korea — From Import Business License to Customs ClearanceThe full path for bringing a foreign medical device into South Korea — import business licensing, product registration, import requirement verification, Korean-language labeling, and UDI registration. Plus the three reasons shipments get stuck at the port.
By class2026.07.08Class 2 Medical Device Certification Guide for KoreaThe correct term for Class 2 is 'certification.' Technical file review, testing, and KGMP first appear here — the 5-step process and the 3 variables that drive the timeline.
By class2026.07.08Class 1 Medical Device Notification Guide for KoreaClass 1 devices proceed by 'notification' with no review. The 4-step process, required documents, and the 3 most common rejection points.
By procedure2026.07.08Medical Device Cybersecurity Guideline for Regulatory ReviewKey cybersecurity review guidelines selected by CLARE Partners for preparing submission dossiers for connected medical devices in Korea.

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