Food & Health › Food & Drug Safety › Medical Devices — Public Data APIs

This public data is public data established to provide medical device item approval information managed by the Ministry of Food and Drug Safety (MFDS). It provides major items such as medical device item name, item grade, item approval number, approval date, item status, and company name. Through this data, accessibility to approved medical device product information is guaranteed.…

This public data was collected for the purpose of monitoring the status of companies holding valid GMP conformity certifications and strengthening quality control by integrally providing the GMP (Good Manufacturing Practices) designation status of medical device manufacturing and importing companies. - Basic information such as company name, manufacturer, address, applicable standards, review status, conformity recognition number, certification validity period, and permission date…

Medical device product information by UDI code is public data that provides detailed information on products based on the Unique Device Identification (UDI-DI). Key items include UDI-DI code, item name, classification number, grade, item approval number and approval date, model name, product name, human-implantable status, disposable status, traceability status, and combination medical device status.…

This public data contains detailed information on medical device items managed by the Ministry of Food and Drug Safety. This data includes item serial number, manufacturing method, intended use, expiration date, approval information, cancellation/withdrawal history, approval date, model name, grade, manufacturer's requester, manufacturer, manufacturing country, etc., enabling the confirmation of registration and approval history by item. This de…

This data provides detailed data on medical device manufacturing and importing companies whose sales have been suspended and recalled. Detailed items include import/manufacturing company name, item name, item approval number, grade, item approval number, model name, manufacturing number, manufacturing date, sales suspension and recall reason, and publication/order date. Through this, sales of importing and manufacturing companies…

This public data provides detailed information on medical device manufacturers and importers managed by the Ministry of Food and Drug Safety. This public data includes items such as business name, business type classification code, suspension/closure/reopening classification code, license date, business address, and business license number, in order to manufacture medical devices domestically or import and distribute them from overseas by food and…

This public data, Medical Device Unique Device Identification (UDI Code) Information, provides UDI-DI (medical device standard code) and related information, which are unique identifiers assigned to medical devices distributed in Korea. This public data is provided in a list format including each medical device's UDI-DI code along with code system, company name, and company type.…

The Ministry of Food and Drug Safety 「Medical Device Classification Number」 OpenAPI provides code systems and attribute information for classifying medical devices. Provided items include medical device classification number, classification number level, upper classification number, classification number grade, item group/item classification, raw material management item status, professional information, purpose of use, usage status, tracking target status, item group code, classification number contents,…

Medical device manufacturer information data managed by the Ministry of Food and Drug Safety includes items such as medical device item serial number, item name, permission date, shape (model name), overview name, serial number, manufacturer country, manufacturer name, manufacturer address 1, and manufacturer address 2. Through this data, in addition to the medical device manufacturer, various information related to medical devices produced by the manufacturer can also be shared.…

The medical device UDI/EDI information inquiry service is public data that systematically provides detailed information on medical devices approved in South Korea. This data is centered around the Unique Device Identification (UDI-DI) assigned to each medical device, enabling identification and tracking. Major provided items include the medical device sub-classification item name, 제…

The medical device integrated company information data provided by the Ministry of Food and Drug Safety includes various detailed items such as business name, business type classification, basic business address, detailed business address, licensing date, licensing authority, business registration number, and closure date. Through this data, basic information and licensing status of medical device integrated companies, accurate business addresses, as well as clos…

This public data is public data regarding medical device import and manufacturing business permit details provided by the Ministry of Food and Drug Safety. Persons intending to engage in the business of manufacturing or importing medical devices must receive permission from the Minister of Food and Drug Safety, and it provides information related to licensing status such as company name, business type, permit date, and location of businesses that have received medical device manufacturing or importing business permits.…

Manufacturer and importer information by medical device standard code is public data that provides detailed information on the company that manufactured or imported the product based on the Unique Device Identification (UDI-DI). Major provided items may include UDI-DI code, company trade name, medical device manufacture/import business license number and permit date, and business address.…

The Ministry of Food and Drug Safety "Traceability-Target Medical Device Information" OpenAPI provides medical device information that requires tracking, such as recalls and sales suspensions during medical device approval and distribution. Major provided items include company name, item name, item approval number, approval date, manufacturer, and country of manufacture. Through this, the approval time and manufacturing of specific medical devices…

This public data is public data regarding details of medical device clinical trial plan approval applications provided by the Ministry of Food and Drug Safety (MFDS). In accordance with Article 21 (Standards and Procedures for Designation of Clinical Trial Institutions, etc.) Paragraph 8 of the 「Enforcement Rule of the Medical Device Act」, the name, location, and representative of medical device clinical trial institutions designated by the Commissioner of the Food and Drug Safety are disclosed. Medical device manufacturing…

This public data is information on the status of companies holding in vitro diagnostic medical devices managed by the Ministry of Food and Drug Safety. It systematically manages the overall status of companies manufacturing, importing, and selling in vitro diagnostic medical devices to enhance industry transparency and disclose related information. The business licensing date shows when the company received a license and started operating, and the location address…

This public data is medical device model name information provided by the Ministry of Food and Drug Safety. It uniquely identifies each medical device through the medical device item serial number and provides a product classification system by institution regional classification and business type. You can check the official approval status with the approval/notification classification and medical device item approval number, and approval date with item name…

This public data allows users to check the list of medical device clinical trial plan approval applications provided by the Ministry of Food and Drug Safety. In accordance with Article 10 (Approval of Clinical Trial Plans, etc.) of the "Medical Devices Act," part of the contents approved for medical device clinical trial plans by the Ministry of Food and Drug Safety is disclosed. To enhance the utilization and convenience of clinical information for researchers and patients…

This public data is raw material information by medical device item provided by the Ministry of Food and Drug Safety (MFDS). This public data uniquely identifies each medical device through the medical device item serial number and medical device item approval number, and provides a product classification system by institution region classification and business type. Approval and report classification, item name, and approval date allow you to check the approval status and timing…

This public data is integrated information by medical device standard code, providing specific substances and characteristics included in products based on the Unique Device Identification (UDI-DI). Major provided items include UDI-DI code, whether latex is included, whether phthalates are included, whether safe for exposure in magnetic resonance imaging (MRI) environments, and the…

Mask approval status basic information data from the Ministry of Food and Drug Safety is public data that allows users to check the approval status of mask items. Main items provided in this data include item standard code, item name, company name, grade, approval date, approval status, and usage classification, through which the type of mask product, manufacturing or importing company, grade classification,…

Provides information related to human tissue banks managed by the Ministry of Food and Drug Safety. Anyone intending to handle human tissues pursuant to the "Act on Safety and Management of Human Tissues" must obtain a tissue bank license pursuant to Article 13 of the same Act. This service includes the license number received by the tissue bank upon establishing the tissue bank, initial license date, name and location of the tissue bank,…

This public data is medical device voluntary reporting information managed by the Ministry of Food and Drug Safety. When medical device manufacturers or importers discover product safety issues or quality defects, they voluntarily report them to the Ministry of Food and Drug Safety to systematically manage them and ensure consumer safety. This data clearly identifies the location of the reporting company through the company name, company address, and business type…

Medical device item groups are a medium-classification system that classifies medical devices according to their function, purpose of use, operating principle, etc., established by the Ministry of Food and Drug Safety (MFDS) to efficiently manage medical device items and grades. This public data includes information such as item group code, item group name, and item group description indicating the medical device classification system.…

The medical device equivalent product information data provided by the Ministry of Food and Drug Safety includes equivalent product manufacturing/import classification, equivalent product approval year, equivalent product approval number, equivalent product approval serial number, equivalent public notice number, equivalent public notice item name, equivalent public notice type number, equivalent public notice date, identity product status, identity product approval number, equivalent public notice product, medical device item number, agency region classification, business type, approval/report classification, medical…

Information established to provide medical device re-evaluation information collected and managed by the Ministry of Food and Drug Safety to secure public health and safety. It includes medical device approval information, recall and sales status, manufacturing facility quality management (GMP) related data, and is used to analyze the appropriateness of approval for items subject to re-evaluation every year. Major items provided include re-evaluation…

The Ministry of Food and Drug Safety 「Innovative Medical Device Designation Status」 OpenAPI provides basic status information on products designated as innovative medical devices. Provided items include business name, item name, model name, designation date, sales start date and time, post-market report date, and designation status, allowing users to know when a specific medical device was designated, when sales started, and post-market reports…

This public data contains information on recall and disposal plans and provides information such as recall and disposal report classification code, recall and disposal report classification, report approval date, report submission date, company name, business type classification code, business name, company address, and public deadline status code. Recall obligators must prepare a recall plan for each product in accordance with Article 52 Paragraph 3 or Article 57 Paragraph 2 of the Enforcement Rule…

This public data contains contents regarding medical device recall and disposal completion reports, and provides information such as recall and disposal report classification, report approval date, report submission date, company name, business type classification code, business type classification name, and company address. Recall obligators must report the completion of recall in accordance with Article 54 Paragraph 3 or Article 57 Paragraph 2 of the Enforcement Rule within 5 days from the end date of the recall…

This data was collected to provide real-time application status by medical device GMP (Good Manufacturing Practice) product group, thereby enhancing the transparency of GMP certification procedures and administrative efficiency. - Detailed items include review application item approval number, item name, class, model name, manufacturer name, country, and address, review office, review method, initial review status, progress status, and manager approval…

This data was collected to provide basic information on the medical device GMP (Good Manufacturing Practice) quality review application process, thereby strengthening the transparency of the review procedure and administrative efficiency. - Based on the GMP quality review application form, detailed items include business name, business address and postal code, business type, review office, review method, institution receipt date, report date, and most…

The medical device convergence product information data provides basic information on medical device convergence products managed by the Ministry of Food and Drug Safety. Medical device convergence products refer to products combining medical devices with pharmaceuticals, biological drugs, herbal medicines (oriental medicines), quasi-drugs, etc., and are classified according to their primary action criteria. This public data includes medical device items…

This public data is medical device advertising prior review information managed by the Ministry of Food and Drug Safety. Each review case is uniquely identified through the review result date and review number, and the applying company can be identified via the company name. In addition, media type information shows the type of media where the advertisement will be published. The target medical devices of the advertisement can be identified by product name and license number…

This public data provides medical device classification document information such as unique item classification numbers, subdivided item grades, and detailed international standards managed by the Ministry of Food and Drug Safety in a tabular list format. Within this public data, you can grasp item grades corresponding to item classification numbers and international standard information at a glance. And use…

This public data contains information on results by recall and disposal method, providing information such as major recall method category, minor recall method category, recall method result content, recall/disposal report classification code, recall/disposal report classification, report approval date, report submission date, business name, business type classification code, business type classification name, business address, and disclosure deadline. Reliable recall and disposal according to the Medical Devices Act…

This public data discloses the names, locations, and representatives of medical device non-clinical testing institutions designated by the Minister of Food and Drug Safety pursuant to Article 24-2, Paragraph 7 of the Enforcement Rule of the Medical Devices Act. To enhance accessibility to non-clinical testing institutions where testing is available when medical device manufacturers and importers request necessary biocompatibility tests,…

This public data is about medical device clinical trial institution information provided by the Ministry of Food and Drug Safety (MFDS). In accordance with Article 21, Paragraph 8 of the Enforcement Rule of the Medical Devices Act (Designation Standards and Procedures for Clinical Trial Institutions, etc.), the names, locations, and representatives of medical device clinical trial institutions designated by the Minister of Food and Drug Safety are disclosed. Medical device manufacturing and importing businesses…

This data provides information on the status of human tissue import approvals managed by the Ministry of Food and Drug Safety. Pursuant to Article 17 of the Act on Safety and Management of Human Tissues, tissue banks intending to import tissues from overseas into Korea must obtain tissue import approval from the Minister of Food and Drug Safety. This data provides a list of human tissue import approval details. Ministry of Food and Drug Safety…

This public data is about medical device packaging unit information provided by the Ministry of Food and Drug Safety (MFDS). This public data provides packaging unit information for medical device items approved by the Ministry of Food and Drug Safety. In addition, for user convenience, medical device item serial numbers, organization region classifications (regional offices managing companies), business types, approval/notification classifications, and medical device item approvals…

Provides a list of human tissue bank permission numbers, transplant result numbers, and transplanted tissue names managed by the Ministry of Food and Drug Safety. According to Article 19, Paragraph 2 of the "Act on Safety and Management of Human Tissues," medical institutions that have transplanted human tissues must prepare a transplant result record form for recipients and notify the tissue bank that distributed the tissues. At this time,…

This data provides standard customs clearance-intended report details submitted to the Korea Pharmaceutical Traders Association by tissue banks that have received tissue import approval pursuant to Article 17 of the "Act on Safety and Management of Human Tissues" to actually import tissues after registering an overseas manufacturing facility, and includes the name of the tissue bank actually importing the tissues, and the name and location of the overseas manufacturing facility exporting the tissues.…

This public data systematically provides reissued medical device GMP compliance certificate data. - Detailed items of this public data include company name, business type, address, postal code and address, review classification/type/application standards, issuance reason and details, compliance date and number, validity period, review office, reissue date, etc. - Through this public data,…

This public data provides information on the medical device adverse event simple standard codebook list from the Ministry of Food and Drug Safety (MFDS). When reporting adverse events occurring during the use of medical devices, medical device handlers report the corresponding medical device problem code, cause investigation code (type, findings, conclusion), health impact code (clinical signs and symptoms or condition, health outcome), etc.…

This public data contains deliberation details by medical device advertising producer managed by the Ministry of Food and Drug Safety. This public data includes information such as advertising business name, representative item name, result notification deliberation number, result notification deliberation result date, result notification result, result notification re-deliberation status, result notification deliberation corrections, and result notification deliberation opinion statement. Anyone intending to advertise medical devices…

This data is human tissue donation receiving information managed by the Ministry of Food and Drug Safety. Pursuant to Article 19, Paragraph 3 of the "Act on Safety and Management of Human Tissues, Etc.", human tissues are required to be tracked from distribution to transplantation for each tissue. Accordingly, tissue banks record the receiving/import date for each tissue received or imported, and the type of tissue received,…

Human tissue donation management status provides information on donors' tissues managed by tissue banks authorized by the Ministry of Food and Drug Safety in accordance with the "Act on Safety and Management of Human Tissues, Etc.". This data includes items such as tissue bank authorization number, statistical year, donated tissue code (name), and quantity of donated tissues. Tissue banks harvest or receive tissues…

This public data informs users managing product information by adverse event. This public data provides information such as target company, adverse event awareness date, adverse event occurrence date, adverse event end date, medical device causal relationship, and latest report date. This data identifies manufacturers or importers related to adverse events through target company information, and identifies adverse event awareness dates, occurrence dates, end dates,…

「인체조직안전 및 관리 등에 관한 법률」 제17조의2에 따라 조직은행이 해외에서 조직을 수입하려는 경우 동법 제17조에 따른 수입승인을 받은 후 이 조항에 따라 해외제조원 등록을 하여야 조직을 수입할 수 있습니다. 해외제조원 등록번호와 수입조직은행명, 제조원의 명칭과 소재지, 수출국가 명 등의 정보가 포…

식품의약품안전처에서 관리하는 의료기기 분류명 유사어 데이터는 의료기기 분류번호와 관련된 다양한 유사어 정보를 목록 형태로 제공합니다. 이 데이터에는 유사어 일련번호, 의료기기 분류번호, 유사어, 분류번호 등급 등의 항목이 포함되어 있으며, 의료기기 명칭의 다양한 표현을 체계적으로 정리해 제공합니다. 이를…

In accordance with Article 19, Paragraph 3 of the 「Act on Safety and Management of Human Tissues, etc.」, the Ministry of Food and Drug Safety requires tissue banks that distributed tissues and medical institutions that transplanted tissues to report the tracking investigation contents, results, and adverse reactions from distribution to transplantation for each tissue. This data includes the types of adverse reactions that must be reported to the Ministry of Food and Drug Safety in the event of an adverse reaction.…

This public data is information on review and evaluation results by medical device adverse event provided by the Ministry of Food and Drug Safety (MFDS). This public data allows users to understand the basic information and chronological progress of an incident through the target company name and the adverse event recognition date, occurrence date, and end date. Each case is uniquely identified by a report serial number, and the target of action is specified to clarify the evaluation scope.…

In accordance with Article 19, Paragraph 3 of the "Act on Safety and Management of Human Tissues," human tissues are required to be tracked from distribution to transplantation for each tissue. Accordingly, tissue banks must keep records of incoming and outgoing tissues. In addition, for tracking management, all tissues are subject to Article…

This public data is information on follow-up actions by medical device adverse event provided by the Ministry of Food and Drug Safety. This public data allows users to understand basic information and temporal progress of an event through the target company name and the adverse event recognition date, occurrence date, and end date. Each case is uniquely identified by a report serial number, and the target of action is specified to clarify the scope of response. Follow-up actions are…

This public data is medical device repair business information provided by the Ministry of Food and Drug Safety (MFDS). For the safe use and continuous performance maintenance of medical devices, detailed information on repair companies is systematically managed to guide medical institutions and users to medical device repair service providers. This data allows users to find repair companies by region through city/province and city/county/district information.…

This public data is list information of the medical device adverse event simple standard codebook provided by the Ministry of Food and Drug Safety (MFDS). Detailed items include FDA source code, NCIT part code, source, cause classification code, cause classification name, FDA preferred Korean term name, FDA preferred English term name, etc. When medical device handlers report adverse events occurring during the use of medical devices,…

This public data was collected to provide re-supplementation information during the medical device GMP review process, thereby enhancing review transparency and quality assurance.- Detailed items include MFDS supplementation content and supplementation items, re-supplementation review results and number of required items, re-supplementation submission date and review date, representative item status, item group exclusion status, review application number and item number, manufacturer name and country…

This public data is data on the designation status of medical device in vitro clinical performance testing institutions managed by the Ministry of Food and Drug Safety. This data includes detailed information on currently designated testing institutions, allowing users to check the name of each institution through the testing institution name and grasp the location of the institution through address information. A unique designation number is provided to clearly identify each institution.…

This public data provided by the Ministry of Food and Drug Safety informs action method information by adverse event. This public data helps grasp the basic information and chronological flow of an incident through the target company name, adverse event occurrence date, end date, and initial report date. Each case is uniquely identified by the report serial number, and the action target and action reason are specified to determine the response scope and basis.…

This public data is pre-advertised medical device item information managed by the Ministry of Food and Drug Safety. It systematically manages the detailed status of advertising target items approved during the pre-review process of medical device advertisements to provide transparent information to the advertising industry and the medical device industry. The advertising business name and advertising business license number clearly identify the identity and licensing status of the advertisement production company…

Information on overseas manufacturers of human tissues for human transplantation managed by the Ministry of Food and Drug Safety. In accordance with Articles 17 and 17-2 of the "Act on Safety and Management of Human Tissues," it provides a list of information on overseas manufacturers approved for import and registered as overseas manufacturers in exporting countries. This data includes the name of the exporting manufacturer, exporting country, and the…

This public data was collected for the purpose of systematically providing data on alternatively reissued medical device GMP compliance certificates. - Detailed items of this public data include reissued compliance certificate number, review application item approval number, item group name, classification number, item name, model name, manufacturer/sponsor (country/name), and manufacturer (country/name/address).…

This public data is medical device preliminary review details managed by the Ministry of Food and Drug Safety. Anyone who intends to advertise a medical device must obtain a review from an autonomous review organization in advance regarding whether the advertisement violates prohibited advertisements under medical device laws and regulations. Systematically provides detailed results of the preliminary review process conducted prior to the main review of medical device advertisements.…

This public data is information on medical device re-evaluation notices provided by the Ministry of Food and Drug Safety (MFDS). This public data contains detailed items such as re-evaluation notice number, code name, notice date, item name, approval date, manufacturing/importing company name and country, submission method and data, and cancellation/withdrawal classification according to the re-evaluation notice. Utilizing this data…

This public data is information regarding medical device reevaluation item application information provided by the Ministry of Food and Drug Safety (MFDS). It is application information for items submitted by manufacturing and importing businesses in accordance with reevaluation announcements, and includes detailed items such as reevaluation serial number, announcement number, item name, approval date, manufacturing/sales business name and country, cancellation/withdrawal status, etc. The data is for application…

This public data is medical device re-evaluation result announcement information provided by the Ministry of Food and Drug Safety. Detailed items such as re-evaluation result announcement number, evaluation year, announcement title, evaluation code name, and evaluation period according to the re-evaluation announcement are included. You can check the evaluation results and follow-up action status for each medical device. Through re-evaluation, cessation of use, conditional maintenance,…

This is a service where you can view a list of statistical information, such as the number of human tissue donations reported to the Ministry of Food and Drug Safety by designated tissue donation registration institutions.

Provides information on the status of human tissue donation management (tissue bank license number, country name, tissue bank name, distribution center name, etc.) managed by the Ministry of Food and Drug Safety. This data includes the types of donated tissue, the country where tissue was donated or harvested, and the tissue banks or overseas manufacturers that harvested and distributed the tissue, in accordance with the Act on Safety and Management of Human Tissues, etc.…

Provides a list of Korea Organ and Tissue Classification System code information (KOCST identification code, KOCST classification code) for efficient human tissue management. The types of human tissues are stipulated as 11 types under Article 3 of the "Act on Safety and Management of Human Tissues", which are bone, cartilage, fascia, skin, amniotic membrane, ligament, tendon, heart valve, blood vessel, nerve, and pericardium. Each tissue is anatomical…

This is human tissue standard customs clearance expected item information managed by the Ministry of Food and Drug Safety. Pursuant to Article 17 of the "Act on Safety and Management of Human Tissues", this is a standard customs clearance report submitted to the Korea Pharmaceutical Traders Association by a tissue bank that has received tissue import approval after registering an overseas manufacturer, in order to actually import tissues. It includes the name of the tissue bank actually importing the tissue, and the exporter of the tissue.…

The Ministry of Food and Drug Safety discloses key attribute information of related national standards to systematically manage national standards in the medical device field, also known as industrial standards or KS specifications, and to improve information accessibility. The provided information includes standard numbers, standard names, relevant Technical Committees, establishment dates, and final revision dates …

This data is collected to check whether matters specified in [Attached Table 3] Minor Changes of the 'Regulations on Medical Device Approval, Notification, Review, etc.' (Ministry of Food and Drug Safety Notice) have been properly reported when reporting minor changes to medical devices. To check whether it was reported as appropriate matters, company name, item name, item classification, grade, report classification, report date…