GGuidelines
Medical device regulatory guidelines.
Korean approval, certification, and notification procedures — with the governing rules, standards, and submission documents — organized for practice.
- 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 Labelling 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. 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.
Just send the product details.
We do the reviewing.
We pre-review device class, required pathway, and data readiness free of charge, and reply within 1 business day. No sign-up.