KoreaMedical DevicesStandards
Recognized Standards and Specifications for Medical Devices
The MFDS has released updated guidance on the risk categorization for Software as a Medical Device.
What are Standards and Specifications?
The Standards and Specifications are test standards determined by the Minister of Food and Drug Safety for medical devices recognized as requiring quality standards. Manufacturers and importers must reflect the latest standards in their manufacturing and quality control processes.
General Standards and Specifications
| Standard Name | Applicable Items | Notification No. (Effective Date) [Annex/Chapter] | Notification No. (Effective Date) [Full Text] |
|---|---|---|---|
| General Standards for Electrical & Mechanical Safety | |||
| [Annex 1] General Standards and Test Methods for Electrical and Mechanical Safety of Medical Devices | No. 2015-115 ('15.12.31) | ||
| [Annex 2] Collateral Standards for Radiation Safety of Medical Devices | No. 2014-122 ('14.5.30) | ||
| [Annex 3] Collateral Standards for Usability of Medical Devices | No. 2014-122 ('14.5.30) | ||
| [Annex 4] Collateral Standards for Alarm Systems in Medical Devices | No. 2014-122 ('14.5.30) | ||
| [Annex 5] Collateral Standards for Physiologic Closed-Loop Controllers | Electrical Medical Devices | No. 2014-122 ('14.5.30) | No. 2025-40 ('25.6.17) |
| [Annex 6] Designation and Definition of Items for In Vitro Diagnostic Analyzers | No. 2014-122 ('14.5.30) | ||
| [Annex 7] General Standards for Electrical/Mechanical Safety of IVD Analyzers | No. 2014-122 ('14.5.30) | ||
| [Annex 8] Designation/Definition of Implantable Electronic Medical Devices[Annex 9] General Standards for Safety of Implantable Electronic Medical Devices | No. 2014-122 ('14.5.30)No. 2014-122 ('14.5.30) | ||
| General Standards for Electromagnetic Safety | |||
| [Annex 1] Electromagnetic Disturbance (Interference)[Annex 2] Electromagnetic Protection (Immunity) | Electrical Medical Devices | No. 2007-32 ('07.7.1)No. 2007-32 ('07.7.1) | No. 2020-29 ('20.5.1) |
| General Standards for Biological Safety | |||
| [Chapter 1] Evaluation and Testing | No. 2011-58 ('11.10.7) | ||
| [Chapter 2] Animal Welfare Requirements | No. 2011-58 ('11.10.7) | ||
| [Chapter 3] Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity | No. 2011-58 ('11.10.7) | ||
| [Chapter 4] Selection of Tests for Interactions with Blood[Chapter 5] Tests for in vitro Cytotoxicity | Human Contact Medical Devices | No. 2014-115 ('14.4.24)No. 2011-58 ('11.10.7) | No. 2025-40 ('25.6.17) |
| [Chapter 6] Tests for Local Effects after Implantation | Human Contact Medical Devices | No. 2011-58 ('11.10.7) | No. 2025-40 ('25.6.17) |
| [Chapter 7] Ethylene Oxide Sterilization Residuals | No. 2011-58 ('11.10.7) | ||
| [Chapter 8] Framework for Identification and Quantification of Potential Degradation Products | No. 2014-115 ('14.4.24) | ||
| [Chapter 9] Tests for Irritation and Skin Sensitization | No. 2014-115 ('14.4.24) | ||
| [Chapter 10] Tests for Systemic Toxicity | No. 2011-58 ('11.10.7) | ||
| [Chapter 11] Sample Preparation and Reference Materials | No. 2011-58 ('11.10.7) | ||
| [Chapter 12] Identification/Quantification of Degradation Products from Polymeric Medical Devices | No. 2014-115 ('14.4.24) | ||
| [Chapter 13] Identification/Quantification of Degradation Products from Ceramic Medical Devices | No. 2011-58 ('11.10.7) | ||
| [Chapter 14] Identification/Quantification of Degradation Products from Metals and Alloys | No. 2011-58 ('11.10.7) | ||
| [Chapter 15] Toxicokinetic Study Design for Degradation Products and Leachables | No. 2014-115 ('14.4.24) | ||
| [Chapter 16] Allowable Limits for Leachables | No. 2011-58 ('11.10.7) | ||
| [Chapter 17] Chemical Characterization of Materials | No. 2011-58 ('11.10.7) |
Particular Standards: Medical Supplies & Dental Materials
| No. | Standard Name | Applicable Items | Notification No. (Effective Date) [Product] | Notification No. (Effective Date) [Full Text] |
|---|---|---|---|---|
| 1 | Solid root canal filling materials | Solid root canal filling materials, Silver points for root canal | No. 2016-90 ('16.8.26) | |
| 2 | Bone cement | Bone cement | No. 2012-96 ('12.8.30) | |
| 3 | Orthodontic brackets | Orthodontic brackets | No. 2012-96 ('12.8.30) | |
| 4 | Male condoms | Male condoms | No. 2005-85 ('05.12.30) | |
| 5 | Dental brazing alloys (Precious, Semi-precious, Non-precious) | Dental brazing gold alloy, Dental brazing noble alloy, Dental brazing non-precious alloy | No. 2012-96 ('12.8.30) | |
| 6 | Resin teeth | Resin teeth | No. 2012-96 ('12.8.30) | |
| 7 | Resin-based pit and fissure sealants (External energy cure) | Resin-based pit and fissure sealants | No. 2012-96 ('12.8.30) | |
| 8 | Resin-based pit and fissure sealants (Self-curing) | Resin-based pit and fissure sealants | No. 2012-96 ('12.8.30) | |
| 9 | Dental alloys for metal-ceramic restorations | Dental precious metal alloy for metal-ceramic, Dental semi-precious metal alloy for metal-ceramic, Dental non-precious metal alloy for metal-ceramic | No. 2012-96 ('12.8.30) | No. 2024-80 ('25.6.18) |
| 10 | Non-absorbable sutures | Non-sterile silk suture, Sterile silk suture, Cotton thread, Linen thread, Polyester suture, Polyethylene suture, Polypropylene suture, Polybutester suture, Polytetrafluoroethylene suture, Polyamide suture, Polyvinylidene fluoride suture, Stainless steel suture, Titanium suture, Nitinol suture, Silver suture, Other non-absorbable sutures | No. 2024-78 ('24.12.6) | |
| 11 | Ceramic teeth | Ceramic teeth | No. 2012-96 ('12.8.30) | |
| 12 | Surgical gloves | Surgical gloves | No. 2018-72 ('18.10.10) | |
| 13 | Polymer-based restorative materials | Polymer-based restorative materials | No. 2012-96 ('12.8.30) | |
| 14 | Paste root canal filling materials, Dental root canal sealing materials | Paste root canal filling materials, Dental root canal sealing materials | No. 2024-80 ('25.6.18) | |
| 15 | Denture base temporary relining materials | Denture base temporary relining materials | No. 2016-90 ('16.8.26) | |
| 16 | Soft denture base relining materials | Soft denture base relining materials | No. 2016-90 ('16.8.26) | |
| 17 | Heat-polymerizable denture base resins | Heat-polymerizable denture base resins | No. 2024-78 ('24.12.6) | |
| 18 | Denture adhesives | Denture adhesives | No. 2016-90 ('16.8.26) | |
| 19 | Intraocular lenses | Intraocular lenses | No. 2012-96 ('12.8.30) | |
| 20 | Dental ceramics | Dental ceramic for general use, Dental ceramic for glass infiltration, Dental ceramic for press casting, Dental ceramic for metal-ceramic system, Dental ceramic for machining, Dental ceramic for casting | No. 2012-96 ('12.8.30) | No. 2024-80 ('25.6.18) |
| 21 | Self/Chemical-polymerizable denture base resins | Self-polymerizable denture base resins, Chemical-polymerizable denture base resins | No. 2024-78 ('24.12.6) | No. 2024-80 ('25.6.18) |
| 22 | Intrauterine contraceptive devices | Intrauterine contraceptive devices | No. 1999-18 | |
| 23 | Dental amalgam in capsules | Dental amalgam in capsules | No. 2020-20 ('20.4.1) | |
| 24 | Dental resin-based cements | Dental resin-based cements | No. 2012-96 ('12.8.30) | |
| 25 | Dental zinc oxide/eugenol & non-eugenol cements | Dental zinc oxide non-eugenol cement, Dental zinc oxide eugenol cement | No. 2016-90 ('16.8.26) | |
| 26 | Dental water-based cements | Dental water-based cements | No. 2012-96 ('12.8.30) | |
| 27 | Dental water-based cements (Zinc phosphate/Silicate) | Dental water-based cements | No. 2012-96 ('12.8.30) | |
| 28 | <Abolished, 2020.4.1> | Dental mercury | ||
| 29 | Dental alginate impression materials | Dental alginate impression materials | No. 2012-96 ('12.8.30) | |
| 30 | Dental hybrid ionomer cements | Dental hybrid ionomer cements | No. 2016-90 ('16.8.26) | |
| 31 | Dental hybrid ionomer cements (Non-restorative) | Dental hybrid ionomer cements | No. 2000-30 ('12.8.30) | |
| 32 | Dental hybrid ionomer cements (Restorative) | Dental hybrid ionomer cements | No. 2000-30 ('12.8.30) | |
| 33 | Dental agar impression materials | Dental agar impression materials | No. 2010-36 ('10.5.28) | |
| 34 | Dental casting precious metal alloys | Dental casting precious metal alloys | No. 2008-41 ('08.7.1) | |
| 35 | Dental casting non-precious metal alloys (Cobalt-based) | Dental casting non-precious metal alloys | No. 2008-41 ('08.7.1) | |
| 36 | Dental casting non-precious metal alloys (Nickel-based) | Dental casting non-precious metal alloys | No. 2008-41 ('08.7.1) | No. 2024-80 ('25.6.18) |
| 37 | Crown and bridge resins | Crown and bridge resins | No. 2012-96 ('12.8.30) | |
| 38 | Contraceptive diaphragms | Contraceptive diaphragms | No. 2012-96 ('12.8.30) | |
| 39 | Synthetic condoms | Male condoms | No. 2016-90 ('16.8.26) |
Particular Standards: Instruments & Machinery
| No. | Standard Name | Applicable Items | Notification No. (Effective Date) [Product] | Notification No. (Effective Date) [Full Text] |
|---|---|---|---|---|
| 1 | Gas anesthesia systems | Gas anesthesia systems | No. 2011-8 ('11.2.21) | No. 2024-80 ('25.6.18) |
| 2 | Ophthalmometers | Ophthalmometers | No. 2011-8 ('11.2.21) | |
| 3 | Personal blood glucose monitoring systems | Personal blood glucose monitoring systems, Personal in vitro diagnostic test reagents II | No. 2017-16 ('17.3.8) | |
| 4 | Stationary incubators | Stationary incubators | No. 2011-8 ('11.2.21) | No. 2024-80 ('25.6.18) |
| 5 | Ophthalmic refractometers | Ophthalmic refractometers | No. 2011-8 ('11.2.21) | |
| 6 | Transcutaneous blood gas analyzers | Transcutaneous blood gas analyzers | No. 2016-90 ('16.8.26) | |
| 7 | Ear infrared thermometers | Ear infrared thermometers | No. 2012-117 ('12.11.30) | |
| 8 | Microwave therapy equipment | Microwave therapy equipment | No. 2016-90 ('16.8.26) | |
| 9 | Electromyographs and evoked response equipment | Electromyographs, General purpose evoked response stimulators, Evoked response measuring apparatus | No. 2012-117 ('12.11.30) | |
| 10 | Endoscopic equipment | Endoscopes | No. 2016-90 ('16.8.26) | |
| 11 | Electroencephalographs | Electroencephalographs | No. 2016-90 ('16.8.26) | |
| 12 | Large steam sterilizers | Large steam sterilizers | No. 2012-117 ('12.11.30) | |
| 13 | Laminaria cervical dilators | Laminaria cervical dilators | No. 2012-96 ('12.8.30) | |
| 14 | Laser surgical equipment | Laser surgical equipment | No. 2011-8 ('11.2.21) | No. 2024-80 ('25.6.18) |
| 15 | Sterile hypodermic needles | Sterile hypodermic needles | No. 2012-96 ('12.8.30) | |
| 16 | Sterile acupuncture needles | Sterile acupuncture needles | No. 2012-96 ('12.8.30) | |
| 17 | Hydrotherapy equipment | Hydrotherapy equipment | No. 2007-83 ('07.12.18) | |
| 18 | General purpose ventilators | General purpose ventilators, Home use ventilators, Neonatal/pediatric ventilators | No. 2016-90 ('16.8.26) | |
| 19 | Hearing aids | Hearing aids | No. 2006-6 ('06.3.7) | |
| 20 | Peritoneal dialysis equipment | Peritoneal dialysis equipment | No. 2016-90 ('16.8.26) | |
| 21 | Non-invasive blood pressure alarms | Non-invasive blood pressure alarms | No. 2011-8 ('11.2.21) | No. 2024-80 ('25.6.18) |
| 22 | Non-implantable vascular access devices | Non-implantable vascular access devices | No. 2012-96 ('12.8.30) | |
| 23 | Manual infusion pumps | Manual infusion pumps, Gas-powered infusion pumps | No. 2016-90 ('16.8.26) | |
| 24 | Infusion sets | Infusion sets | No. 2012-96 ('12.8.30) | |
| 25 | Transfusion sets | Transfusion sets | No. 2012-96 ('12.8.30) | |
| 26 | Phototherapy units for newborn jaundice | Phototherapy units for newborn jaundice | No. 2016-90 ('16.8.26) | |
| 27 | Electrocardiographs | Electrocardiographs, Multi-function ECG, Wireless ECG systems, Real-time analysis ECG, U-healthcare ECG | No. 2016-90 ('16.8.26) | |
| 28 | ECG monitors | ECG monitors | No. 2016-90 ('16.8.26) | |
| 29 | Fundus cameras | Fundus cameras | No. 2011-8 ('11.2.21) | |
| 30 | Transport incubators | Transport incubators, Mobile incubators | No. 2011-8 ('11.2.21) | No. 2024-80 ('25.6.18) |
| 31 | Remote-controlled brachytherapy afterloading projectors | Remote-controlled brachytherapy afterloading projectors | No. 2011-8 ('11.2.21) | |
| 32 | Infant radiant warmers | Infant radiant warmers | No. 2016-90 ('16.8.26) | |
| 33 | Hyperbaric oxygen chambers | Hyperbaric oxygen chambers | No. 2011-8 ('11.2.21) | |
| 34 | Medical phototherapy equipment | High-power phototherapy units, Low-power phototherapy units, Pulsed phototherapy units, Dental tooth whitening phototherapy units, Personal phototherapy units, UV irradiators, IR irradiators | No. 2020-97 ('20.5.1) | |
| 35 | Medical refrigerated centrifuges | Medical temperature-controlled centrifuges | No. 2011-8 ('11.2.21) | |
| 36 | Medical oxygen concentrators | Medical oxygen concentrators | No. 2007-83 ('07.12.18) | |
| 37 | Medical heating pads | Medical heating pads/Personal heating pads, Personal air heating pads, Personal water heating pads | No. 2016-90 ('16.8.26) | |
| 38 | Medical infrared thermographic equipment | Medical infrared thermographic equipment | No. 2016-90 ('16.8.26) | |
| 39 | Medical defibrillators | Medical defibrillators | No. 2011-8 ('11.2.21) | |
| 40 | Medical suction equipment | Medical suction equipment | No. 2012-117 ('12.11.30) | |
| 41 | Artificial kidneys | Artificial kidneys, High-permeability artificial kidneys | No. 2016-90 ('16.8.26) | |
| 42 | Magnetic Resonance Imaging (MRI) equipment | MRI equipment, MRI systems | No. 2006-6 ('06.3.7) | No. 2024-80 ('25.6.18) |
| 43 | Automated electronic sphygmomanometers | Automated electronic sphygmomanometers | No. 2007-83 ('07.12.18) | No. 2024-80 ('25.6.18) |
| 44 | Low-frequency stimulators | Low-frequency stimulators, Interferential current low-frequency stimulators, TENS, Personal low-frequency stimulators, Personal combined stimulators | No. 2016-90 ('16.8.26) | |
| 45 | Low-energy defibrillators (AED) | Low-energy defibrillators | No. 2011-8 ('11.2.21) | No. 2024-80 ('25.6.18) |
| 46 | Electrosurgical units | General electrosurgical units (including electrodes), Endoscopic electrosurgical units, Ophthalmic electrosurgical units, Dental electrosurgical units, Medical electric cautery, Vitrectomy devices (with diathermy), Lens cutters (with diathermy) | No. 2016-90 ('16.8.26) | No. 2024-80 ('25.6.18) |
| 47 | Electric infusion pumps | Electric infusion pumps | No. 2016-90 ('16.8.26) | |
| 48 | Electric wheelchairs & Medical scooters | Electric wheelchairs, Medical scooters | No. 2024-80 ('25.6.18) | |
| 49 | Whole body CT X-ray equipment | Whole body CT X-ray equipment | No. 2011-8 ('11.2.21) | No. 2024-80 ('25.6.18) |
| 50 | Electronic thermometers | Electronic thermometers | No. 2016-90 ('16.8.26) | No. 2024-80 ('25.6.18) |
| 51 | Orthopedic exercise devices (Fixed limb) | Fixed limb exercise therapy devices | No. 2008-77 ('08.12.5) | |
| 52 | Orthopedic exercise devices (Gait training) | Gait training devices | No. 2008-77 ('08.12.5) | |
| 53 | Syringes (Sterile single-use) | Single-use syringes | No. 2012-96 ('12.8.30) | |
| 54 | Syringes (Insulin) | Insulin syringes | No. 2016-90 ('16.8.26) | |
| 55 | Interventional X-ray equipment | Mobile analog fluoroscopic interventional X-ray, Mobile digital fluoroscopic interventional X-ray, Stationary digital fluoroscopic interventional X-ray, Stationary analog fluoroscopic interventional X-ray | No. 2016-90 ('16.8.26) | |
| 56 | Diagnostic X-ray equipment | Diagnostic X-ray equipment, Fluoroscopic X-ray equipment, Diagnostic fluoroscopic X-ray, Mobile fluoroscopic X-ray, Tomographic X-ray, Indirect X-ray, Mobile X-ray, Portable X-ray, Digital diagnostic X-ray, Mobile digital diagnostic X-ray, Portable digital diagnostic X-ray | No. 2016-90 ('16.8.26) | No. 2024-80 ('25.6.18) |
| 57 | Extracorporeal shock wave lithotripters | Extracorporeal shock wave lithotripters | No. 2006-6 ('06.3.7) | No. 2024-80 ('25.6.18) |
| 58 | External pacemakers | External pacemakers | No. 2016-90 ('16.8.26) | |
| 59 | Shortwave therapy equipment | Shortwave therapy equipment, Personal shortwave therapy equipment | No. 2016-90 ('16.8.26) | |
| 60 | Ultrasonic Doppler diagnostic equipment | Ultrasonic Doppler diagnostic equipment | No. 2011-8 ('11.2.21) | |
| 61 | Ultrasonic imaging diagnostic equipment | Ultrasonic imaging diagnostic equipment | No. 2011-8 ('11.2.21) | |
| 62 | Ultrasonic stimulators | Ultrasonic stimulators, Personal ultrasonic stimulators | No. 2016-90 ('16.8.26) | |
| 63 | Dental extraoral X-ray equipment | Dental diagnostic extraoral X-ray, Dental diagnostic panoramic X-ray, Digital dental diagnostic extraoral X-ray, Digital dental diagnostic panoramic X-ray, Dental CT X-ray | No. 2024-78 ('24.12.6) | |
| 64 | Dental intraoral X-ray equipment | Digital dental diagnostic intraoral X-ray, Dental diagnostic intraoral X-ray | No. 2024-78 ('24.12.6) | |
| 65 | Dental needles | Dental needles | No. 2016-90 ('16.8.26) | |
| 66 | Dental units | Dental lights, Electric dental handpieces, Pneumatic dental handpieces, Dental surgical handpieces, Dental units & chairs, Dental units, Dental chairs, Dental surgical engines, Dental implant surgical engines, Dental implant surgical handpieces | No. 2016-90 ('16.8.26) | No. 2024-80 ('25.6.18) |
| 67 | Radiotherapy simulators | Radiotherapy simulators | No. 2016-90 ('16.8.26) | |
| 68 | Catheter guidewires | Vascular catheter guidewires, Cardiovascular catheter guidewires, Cerebrovascular catheter guidewires, Enteral catheter guidewires | No. 2012-96 ('12.8.30) | |
| 69 | Cartridge syringes | Cartridge syringes | No. 2016-90 ('16.8.26) | |
| 70 | Cartridge syringes (Dental) | Dental cartridge syringes | No. 2016-90 ('16.8.26) | |
| 71 | Nasal irrigation kits | Manual nasal irrigation kits, Electric nasal irrigation kits | No. 2018-72 ('18.10.10) | |
| 72 | Pulse oximeters | Pulse oximeters | No. 2016-90 ('16.8.26) | |
| 73 | Balloon dilatation catheters | Balloon dilatation catheters | No. 2012-96 ('12.8.30) | No. 2024-80 ('25.6.18) |
| 74 | Hard/Soft contact lenses | Daily wear hard contact lenses, Daily wear soft contact lenses | No. 2016-90 ('16.8.26) | |
| 75 | Invasive blood pressure monitors | Invasive blood pressure monitors | No. 2016-90 ('16.8.26) | |
| 76 | Blood storage containers | Blood storage containers | No. 2012-96 ('12.8.30) | |
| 77 | Respiratory monitors | Respiratory monitors, Spirometers, Pulmonary exercise monitors, Exhaled gas analyzers, Carbon dioxide analyzers | No. 2016-90 ('16.8.26) | |
| 78 | Holter electrocardiographs | Holter electrocardiographs | No. 2016-90 ('16.8.26) | |
| 79 | Patient monitors | Patient monitors, Modular patient monitors | No. 2016-90 ('16.8.26) | No. 2024-80 ('25.6.18) |
| 80 | Filter syringes | Filter syringes, Medicine injection filters (filtration test), Single-use injection filters (filtration test) | No. 2019-40 ('19.5.20) | |
| 81 | Single-use filter needles | Single-use filter needles | No. 2019-40 ('19.5.20) |
Particular Standards: Class 1 Medical Devices
| No. | Standard Name | Applicable Items | Notification No. (Effective Date) [Product] | Notification No. (Effective Date) [Full Text] |
|---|---|---|---|---|
| 1 | Root canal paper points | Absorbent paper points among root canal paper points | No. 2019-61 ('19.7.19) | |
| 2 | Surgical thimbles | Surgical thimbles | No. 2019-61 ('19.7.19) | |
| 3 | Examination gloves | Examination gloves (Powder-free) | No. 2020-97 ('20.5.1) | |
| 4 | Orthodontic appliances | Orthodontic elastics, bands, chains, threads, and ligatures among orthodontic appliances | No. 2019-61 ('19.7.19) | |
| 5 | Dental baseplate wax | Dental baseplate wax | No. 2019-61 ('19.7.19) | |
| 6 | Dental impression compound | Dental impression compound | No. 2019-61 ('19.7.19) | |
| 7 | Dental casting wax | Casting wax | No. 2019-61 ('19.7.19) | |
| 8 | Retinoscopes | Retinoscopes | No. 2019-61 ('19.7.19) | |
| 9 | Enema kits | Enema kits | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 10 | Radiation protection aprons | Radiation protection aprons | No. 2019-61 ('19.7.19) | |
| 11 | Radiation protection gloves | Radiation protection gloves | No. 2019-61 ('19.7.19) | |
| 12 | Radiation protection screens | Radiation protection screens | No. 2019-61 ('19.7.19) | |
| 13 | Radiographic film cassettes | Radiographic film cassettes | No. 2019-61 ('19.7.19) | |
| 14 | Non-sterile injection needles | Non-sterile injection needles | No. 2019-61 ('19.7.19) | |
| 15 | Non-sterile acupuncture needles | Non-sterile acupuncture needles | No. 2019-61 ('19.7.19) | |
| 16 | Anti-scatter grids | Anti-scatter grids | No. 2019-61 ('19.7.19) | |
| 17 | Surgical operating lights | Surgical operating lights | No. 2019-61 ('19.7.19) | |
| 18 | <Abolished, 2020.4.1> | Mercury glass thermometers | ||
| 19 | Spectacle lenses | Unfinished spectacle lenses, Spectacle lenses | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 20 | Glass syringes | Glass syringes | No. 2019-61 ('19.7.19) | |
| 21 | Medical film viewers | Medical film viewers | No. 2019-61 ('19.7.19) | |
| 22 | Electric operating tables | Electric operating tables | No. 2019-61 ('19.7.19) | |
| 23 | Electric medical beds | Electric medical beds and accessories | No. 2019-61 ('19.7.19) | |
| 24 | Slit lamps | Slit lamps | No. 2019-61 ('19.7.19) | |
| 25 | Reusable filter needles | Reusable filter needles | No. 2019-61 ('19.7.19) | |
| 26 | Manual medical beds | Manual medical beds (Adult) | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 27 | Rigid otoscopes | Rigid otoscopes | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 28 | Intraoral cameras | Intraoral cameras | No. 2019-61 ('19.7.19) | |
| 29 | Oxygen administration tubing/catheters | Oxygen administration tubing/catheters | No. 2019-61 ('19.7.19) | |
| 30 | Respiratory masks | Respiratory masks | No. 2019-61 ('19.7.19) | |
| 31 | Suction tubing/catheters | Suction tubing/catheters | No. 2019-61 ('19.7.19) | |
| 32 | Aneroid sphygmomanometers | Aneroid sphygmomanometers | No. 2019-61 ('19.7.19) | |
| 33 | Medical calipers | Medical calipers | No. 2019-61 ('19.7.19) | |
| 34 | <Abolished, 2020.4.1> | Mercury sphygmomanometers | ||
| 35 | Color change thermometers | Color change thermometers | No. 2019-61 ('19.7.19) | |
| 36 | Radiation protection eyewear | Radiation protection eyewear | No. 2019-61 ('19.7.19) | |
| 37 | Darkroom film processors | Darkroom film processors | No. 2019-61 ('19.7.19) | |
| 38 | Radiation protection thoracic aprons | Radiation protection thoracic aprons | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 39 | Gonad protection devices | Gonad protection devices | No. 2019-61 ('19.7.19) | |
| 40 | Reusable general manual forceps | Reusable general manual forceps | No. 2019-61 ('19.7.19) | |
| 41 | Reusable manual medical scissors | Reusable manual medical scissors | No. 2019-61 ('19.7.19) | |
| 42 | Reusable general endoscopic instruments | Reusable general endoscopic instruments | No. 2019-61 ('19.7.19) | |
| 43 | Electric patient lifts | Electric patient lifts | No. 2019-61 ('19.7.19) | |
| 44 | Electric patient transporters | Electric patient transporters | No. 2019-61 ('19.7.19) | |
| 45 | External general purpose probes | External general purpose probes | No. 2019-61 ('19.7.19) | |
| 46 | External medical cameras | External medical cameras | No. 2019-61 ('19.7.19) | |
| 47 | Dental mirrors | Dental mirrors | No. 2019-61 ('19.7.19) | |
| 48 | Dental implant instruments | Dental implant instruments | No. 2019-61 ('19.7.19) | |
| 49 | Dental explorers | Dental explorers | No. 2019-61 ('19.7.19) | |
| 50 | Dental visible light curing units | Dental visible light curing units | No. 2019-61 ('19.7.19) | |
| 51 | Single-use urine flow/volume measuring devices | Single-use urine flow/volume measuring devices | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 52 | Vacuum blood collection tubes | Vacuum blood collection tubes | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 53 | Reusable urine flow/volume measuring devices | Reusable urine flow/volume measuring devices | No. 2019-61 ('19.7.19) | |
| 54 | Medical headlamps | Medical headlamps | No. 2019-61 ('19.7.19) | |
| 55 | Patient restraints | Patient restraints | No. 2019-61 ('19.7.19) | |
| 56 | General manual examination tables | General manual examination tables | No. 2019-61 ('19.7.19) | |
| 57 | General electric examination tables | General electric examination tables | No. 2019-61 ('19.7.19) | |
| 58 | Manual operating tables | Manual operating tables | No. 2019-61 ('19.7.19) | |
| 59 | Electric hydraulic operating tables | Electric hydraulic operating tables | No. 2019-61 ('19.7.19) | |
| 60 | OB/GYN electric hydraulic examination tables | OB/GYN electric hydraulic examination tables | No. 2019-61 ('19.7.19) | |
| 61 | OB/GYN electric hydraulic delivery tables | OB/GYN electric hydraulic delivery tables | No. 2019-61 ('19.7.19) | |
| 62 | OB/GYN electric delivery tables | OB/GYN electric delivery tables | No. 2019-61 ('19.7.19) | |
| 63 | OB/GYN electric examination tables | OB/GYN electric examination tables | No. 2019-61 ('19.7.19) | |
| 64 | Manual diagnostic X-ray tables | Manual diagnostic X-ray tables | No. 2019-61 ('19.7.19) | |
| 65 | Electric diagnostic X-ray tables | Electric diagnostic X-ray tables | No. 2019-61 ('19.7.19) | |
| 66 | Manual patient transporters | Manual patient transporters | No. 2019-61 ('19.7.19) | |
| 67 | Manual patient lifts | Manual patient lifts | No. 2019-61 ('19.7.19) | |
| 68 | Manual examination chairs | Manual examination chairs | No. 2019-61 ('19.7.19) | |
| 69 | Medical bed actuators | Medical bed actuators | No. 2019-61 ('19.7.19) | |
| 70 | Electric examination chairs | Electric examination chairs | No. 2019-61 ('19.7.19) | |
| 71 | Urology electric examination tables | Urology electric examination tables | No. 2019-61 ('19.7.19) | |
| 72 | Medical image printers | Medical image printers | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 73 | Medical film printers | Medical film printers | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 74 | Photostimulable phosphor cassettes | Photostimulable phosphor cassettes | No. 2019-61 ('19.7.19) | |
| 75 | Medical camera heads | Medical camera heads | No. 2019-61 ('19.7.19) | |
| 76 | Head reflectors | Head reflectors | No. 2019-61 ('19.7.19) | |
| 77 | Manual reusable medical perforators | Manual reusable medical perforators | No. 2019-61 ('19.7.19) | |
| 78 | Manual medical hammers | Manual medical hammers | No. 2019-61 ('19.7.19) | |
| 79 | Manual medical saws | Manual medical saws | No. 2019-61 ('19.7.19) | |
| 80 | Manual medical elevators | Manual medical elevators | No. 2019-61 ('19.7.19) | |
| 81 | Manual medical probes | Manual medical probes | No. 2019-61 ('19.7.19) | |
| 82 | Manual endoscopic knives | Manual endoscopic knives | No. 2019-61 ('19.7.19) | |
| 83 | Manual medical files | Manual medical files | No. 2019-61 ('19.7.19) | |
| 84 | Manual medical chisels | Manual medical chisels | No. 2019-61 ('19.7.19) | |
| 85 | Reusable endoscopic forceps | Reusable endoscopic forceps | No. 2019-61 ('19.7.19) | |
| 86 | Reusable medical forceps | Reusable medical forceps | No. 2019-61 ('19.7.19) | |
| 87 | Electric medical forceps | Electric medical forceps | No. 2019-61 ('19.7.19) | |
| 88 | Reusable manual medical curettes | Reusable manual medical curettes | No. 2019-61 ('19.7.19) | |
| 89 | Reusable manual medical knives | Reusable manual medical knives | No. 2019-61 ('19.7.19) | |
| 90 | Reusable general manual clamps | Reusable general manual clamps | No. 2019-61 ('19.7.19) | |
| 91 | Reusable endoscopic biopsy instruments | Reusable endoscopic biopsy instruments | No. 2019-61 ('19.7.19) | |
| 92 | Reusable endoscopic cannulas | Reusable endoscopic cannulas | No. 2019-61 ('19.7.19) | |
| 93 | Reusable endoscopic dilators | Reusable endoscopic dilators | No. 2019-61 ('19.7.19) | |
| 94 | Reusable endoscopic scissors | Reusable endoscopic scissors | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 95 | Reusable endoscopic trocars | Reusable endoscopic trocars | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 96 | Reusable endoscopic snares | Reusable endoscopic snares | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 97 | Reusable endoscopic sponge forceps | Reusable endoscopic sponge forceps | No. 2019-61 ('19.7.19) | |
| 98 | Reusable endoscopic injection needles | Reusable endoscopic injection needles | No. 2019-61 ('19.7.19) | |
| 99 | Reusable ophthalmic knives | Reusable ophthalmic knives | No. 2019-61 ('19.7.19) | |
| 100 | Reusable manual retractors | Reusable manual retractors | No. 2019-61 ('19.7.19) | |
| 101 | Reusable medical suturing instruments | Reusable medical suturing instruments | No. 2019-61 ('19.7.19) | |
| 102 | Medical measuring rulers | Medical measuring rulers | No. 2019-61 ('19.7.19) | |
| 103 | Bone forceps | Bone forceps | No. 2019-61 ('19.7.19) | |
| 104 | Dental abrasives | Dental abrasives | No. 2019-61 ('19.7.19) | |
| 105 | Dental implant drills | Dental implant drills | No. 2019-61 ('19.7.19) | |
| 106 | Medical depressors | Medical depressors | No. 2019-61 ('19.7.19) | |
| 107 | Tourniquets | Tourniquets | No. 2019-61 ('19.7.19) | |
| 108 | Compression bands | Compression bands | No. 2019-61 ('19.7.19) | |
| 109 | Splints | Splints | No. 2019-61 ('19.7.19) | |
| 110 | Non-contact reusable surgical drapes | Non-contact reusable surgical drapes | No. 2019-61 ('19.7.19) | |
| 111 | Non-implantable medical silicone materials | Non-implantable medical silicone materials | No. 2019-61 ('19.7.19) | |
| 112 | Lacrimal sacs | Lacrimal sacs | No. 2019-61 ('19.7.19) | |
| 113 | External medical electrodes | External medical electrodes | No. 2019-61 ('19.7.19) | |
| 114 | Personal displays for medical endoscopes | Personal displays for medical endoscopes | No. 2019-61 ('19.7.19) | |
| 115 | Endoscopic insertion guides | Endoscopic insertion guides | No. 2019-61 ('19.7.19) | |
| 116 | Endoscopic connectors | Endoscopic connectors | No. 2019-61 ('19.7.19) | |
| 117 | Endoscopic ligating instruments | Endoscopic ligating instruments | No. 2019-61 ('19.7.19) | |
| 118 | Endoscopic dissectors | Endoscopic dissectors | No. 2019-61 ('19.7.19) | |
| 119 | Endoscopic probes | Endoscopic probes | No. 2019-61 ('19.7.19) | |
| 120 | Reusable endoscopic stone extractors | Reusable endoscopic stone extractors | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 121 | Reusable endoscopic aspirators | Reusable endoscopic aspirators | No. 2019-61 ('19.7.19) | |
| 122 | Manual medical aspirators | Manual medical aspirators | No. 2019-61 ('19.7.19) | |
| 123 | Medical opening instruments | Medical opening instruments | No. 2019-61 ('19.7.19) | |
| 124 | Medical cutting instruments | Medical cutting instruments | No. 2019-61 ('19.7.19) | |
| 125 | Manual bone surgical instruments | Manual bone surgical instruments | No. 2019-61 ('19.7.19) | |
| 126 | Manual periosteal elevators | Manual periosteal elevators | No. 2019-61 ('19.7.19) | |
| 127 | Reusable external fixation devices | Reusable external fixation devices | No. 2019-61 ('19.7.19) | |
| 128 | Medical packers | Medical packers | No. 2019-61 ('19.7.19) | |
| 129 | Medical guides | Medical guides | No. 2019-61 ('19.7.19) | |
| 130 | Medical gauges | Medical gauges | No. 2019-61 ('19.7.19) | |
| 131 | Orthopedic templates | Orthopedic templates | No. 2019-61 ('19.7.19) | |
| 132 | Tongue depressors | Tongue depressors | No. 2019-61 ('19.7.19) | |
| 133 | Laryngoscopes (Rigid) | Rigid laryngoscopes | No. 2019-61 ('19.7.19) | |
| 134 | Medical microscopes | Medical microscopes | No. 2019-61 ('19.7.19) | |
| 135 | Vision correction spectacles | Vision correction spectacles | No. 2019-61 ('19.7.19) | No. 2024-80 ('25.6.18) |
| 136 | Laser protection eyewear | Laser protection eyewear | No. 2019-61 ('19.7.19) | |
| 137 | Centrifuges | Centrifuges |
Reference: https://www.mfds.go.kr/eng/brd/m_69/view.do?seq=75286&srchFr=&srchTo=&srchKey=&srchVal=&pageIndex=1