What a product had to prove before it reached you

Premarket Notification, section 510(k) of the Federal Food, Drug, and Cosmetic Act; substantial-equivalence standard at section 513(i)(1)(A) FD&C Act; submission requirements at 21 CFR Part 807 Subpart E · FDA, Center for Devices and Radiological Health (CDRH)

"A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act)." And: "Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order 'clears' the device for commercial distribution." [Page states: Content current as of 08/22/2024]

Requires, as transcribed: Proof that the device is substantially equivalent to a legally marketed 'predicate' device. Per FDA: same intended use as the predicate AND same technological characteristics; OR same intended use AND different technological characteristics that do not raise different questions of safety and effectiveness, with information demonstrating the device is as safe and effective as the legally marketed device. The submitter must receive an SE order letter from FDA BEFORE marketing. FDA says this order 'clears' the device — it does not approve it.

Does not require, as transcribed: Does NOT require a freestanding demonstration that the device is safe and effective on its own evidence — it is a comparison to something already on the market. Does NOT require clinical trials in every case (bench, biocompatibility, sterility, software data may suffice). Does NOT involve FDA approval: FDA states it 'does not typically perform 510(k) pre-clearance facility inspections.' A predicate chain can reach back to a pre-1976 preamendment device that was never itself reviewed for safety and effectiveness. NOT the route for dermal fillers, which are Class III/PMA.

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Premarket Approval, section 515 of the Federal Food, Drug, and Cosmetic Act; regulations at 21 CFR Part 814 (Premarket Approval of Medical Devices) · FDA, Center for Devices and Radiological Health (CDRH)

"Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices... PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)." [Page states: Content current as of 05/16/2019]

Requires, as transcribed: Sufficient valid scientific evidence — normally including clinical investigation data — to assure FDA that the device is safe and effective for its intended use(s). FDA must APPROVE the application before the device may be marketed. This is the route for injectable dermal/soft-tissue fillers, which FDA describes as 'medical device implants approved by the FDA' (dermal filler page, Content current as of 07/06/2023). Approval is granted for specific indications and populations (FDA has approved fillers for adults 22 years of age or older, for named uses).

Does not require, as transcribed: Does NOT require a predicate device — it is not an equivalence route. Does NOT permit marketing on the strength of a comparison to an existing product. Conversely, a PMA approval does NOT cover uses outside the approved indication; off-label injection sites and off-label indications are not covered by the approval, and approval of one filler does not extend to another manufacturer's product.

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Biologics License Application under section 351 of the Public Health Service (PHS) Act, with requirements under the FD&C Act; regulations at 21 CFR Parts 600–680, licensing at 21 CFR Part 601 · FDA — Center for Biologics Evaluation and Research (CBER) for tissue/cell/blood biologics; Center for Drug Evaluation and Research (CDER) for therapeutic biologics including botulinum toxin products

"A Biologics License Application (BLA) is the formal submission to the U.S. Food and Drug Administration (FDA) through which an applicant requests permission to introduce a biological product into interstate commerce... If the agency determines that the data adequately demonstrate the product's safety, effectiveness, and quality, and that the manufacturing facility meets required standards, it will issue a U.S. license, permitting the applicant to market and distribute the biological product in the United States." [Page states: Content current as of 07/17/2026]

Requires, as transcribed: A comprehensive data package establishing the product's safety, effectiveness and manufacturing quality: full Chemistry/Manufacturing/Controls detail on the facility, production process and batch-to-batch consistency; full nonclinical laboratory and animal study reports; clinical pharmacology; results of ALL human clinical trials; and proposed labeling. The manufacturing facility must meet required standards. FDA then issues a U.S. license permitting marketing. This is the route for botulinum toxin injectables.

Does not require, as transcribed: Does NOT require a predicate or any equivalence comparison. A BLA licence is product- and indication-specific: it does NOT authorise other manufacturers' versions, imported or unlicensed toxin, or uses outside the approved labeling. Establishment registration with FDA is a separate and much lower bar and is NOT a substitute for a licence.

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New Drug Application under section 505(b) of the Federal Food, Drug, and Cosmetic Act; regulations at 21 CFR Part 314 · FDA, Center for Drug Evaluation and Research (CDER)

"Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA." [Page states: Content current as of 01/21/2022]

Requires, as transcribed: Enough information for FDA to decide: (1) whether the drug is safe and effective in its proposed use(s) and whether the benefits outweigh the risks; (2) whether the proposed labeling (package insert) is appropriate and what it should contain; (3) whether the manufacturing methods and controls are adequate to preserve the drug's identity, strength, quality and purity. The data from animal studies and human clinical trials conducted under an Investigational New Drug (IND) application become part of the NDA. FDA must approve the NDA before U.S. commercialization. This is the route for injectable deoxycholic acid for submental fat.

Does not require, as transcribed: Does NOT require a predicate or equivalence showing. Approval is indication-specific and does NOT extend to other body areas, other formulations, or compounded or imported versions of the same molecule.

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Section 361 of the Public Health Service Act; 21 CFR Part 1271. Criteria at 21 CFR 1271.10(a). Definitions at 21 CFR 1271.3. Registration numbering at 21 CFR 1271.27. FDA guidance: 'Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use' (Guidance for Industry and FDA Staff, July 2020, Docket No. FDA-2017-D-6146, issued by CBER and CDRH) · FDA, Center for Biologics Evaluation and Research (CBER)

21 CFR 1271.27: '(a) FDA will assign each location a permanent registration number. (b) FDA acceptance of an establishment registration and HCT/P listing form does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by FDA.' — 21 CFR 807.39: 'Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.' — FDA regenerative medicine page: 'the fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed.'

Requires, as transcribed: THE FOUR CRITERIA, VERBATIM from 21 CFR 1271.10(a) — 'An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria: (1) The HCT/P is minimally manipulated; (2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent; (3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and (4) Either: (i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or (ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and: (a) Is for autologous use; (b) Is for allogeneic use in a first-degree or second-degree blood relative; or (c) Is for reproductive use.' ALL FOUR must be met. WHAT THE TERMS MEAN — 'Minimal manipulation' (21 CFR 1271.3(f)) means: '(1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement; and (2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.' 'Homologous use' (21 CFR 1271.3(c)) means: 'the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.' 'HCT/Ps' (21 CFR 1271.3(d)) are 'articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.' ONGOING DUTIES if the criteria are met: register the establishment with FDA and list each HCT/P (21 CFR 1271.10(b)), plus donor eligibility and Current Good Tissue Practice requirements in Part 1271. PRACTICAL CONSEQUENCE FOR AESTHETICS: injecting amniotic fluid, umbilical cord/Wharton's jelly, stromal vascular fraction or exosomes to rejuvenate or volumise skin is not the same basic function those tissues perform in the donor, so it fails the homologous-use criterion; FDA lists exactly these as unapproved products.

Does not require, as transcribed: CRITICAL: a genuine 361 HCT/P undergoes NO FDA premarket review whatsoever — no approval, no clearance, no licence, no efficacy data, no clinical trials, and no product-level authorisation number. Nobody at FDA evaluates the product before it reaches a clinic. Registration and listing is a notification duty, not a permission. If a product FAILS any of the four criteria it is NOT a 361 HCT/P — it is a drug, device and/or biological product requiring an IND plus BLA/NDA/PMA, and marketing it without one is unlawful. Registration is emphatically NOT approval: 21 CFR 1271.27(b) states 'FDA acceptance of an establishment registration and HCT/P listing form does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by FDA.'

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Federal Food, Drug, and Cosmetic Act — definition at sec. 201(i); adulteration/misbranding at secs. 601–602; Fair Packaging and Labeling Act (FPLA). Facility registration and product listing added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FD&C Act secs. 604–610 (registration renewal at sec. 607(a)(2)). · FDA, Office of Cosmetics and Colors

'The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market...' and 'Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives.' [Content current as of 11/18/2025] — and from the MoCRA registration page: 'Cosmetic product facility registration and product listing is neither a cosmetic approval program nor a promotional tool. FDA does not issue "certificates" for cosmetic product facility registrations or product listings.' [Content current as of 07/02/2026]

Requires, as transcribed: No FDA premarket approval of the product at all, except for color additives. The company itself carries the safety burden: 'Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products.' The product must be properly labeled and not adulterated or misbranded. Under MoCRA, manufacturers and processors must register each facility with FDA and renew biennially, and the 'responsible person' must list each marketed cosmetic product with FDA including ingredients, updated annually. A cosmetic is defined by intended use: 'articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.'

Does not require, as transcribed: No premarket approval, no FDA review of safety data, no efficacy evidence, no FDA testing, and no product authorisation number. FDA does not issue certificates. CRITICALLY FOR INJECTABLES: this route is NOT available to an injectable aesthetic product. FDA states that if a product is 'intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it's a drug (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if it affects the appearance.' An injectable that fills, volumises, or paralyses acts on the structure or function of the body and is therefore a drug, biologic or device — so a 'cosmetic' claim, a MoCRA facility registration, or an FEI number can never be the lawful basis for selling an injectable to a clinic. Marketing that presents MoCRA registration as an approval is precisely what FDA disclaims.

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인체조직안전 및 관리 등에 관한 법률 (short title 인체조직법). Official English title as published by law.go.kr: "SAFETY AND MANAGEMENT OF HUMAN TISSUE ACT". Law ID 009609. Current consolidated version: promulgated 2024-03-19, Act No. 20381, in force 2024-03-19 (부분개정/일부개정). Subordinate instruments read: 「인체조직안전에 관한 규칙」 (Rule on Human Tissue Safety, 총리령 No. 2079, promulgated and in force 2025-12-30, MST 282283); MFDS Notification 「조직은행 허가 및 인체조직 안전관리 등에 관한 규정」 (식품의약품안전처고시 제2025-69호, issued and in force 2025-10-23). · 식품의약품안전처장 (Minister/Commissioner of Food and Drug Safety) grants the tissue bank permit and every import approval (Arts. 13, 17, 17-2). The law.go.kr record for the Act lists 소관부처 as 식품의약품안전처 in the full-text record and 보건복지부·식품의약품안전처 (MOHW + MFDS) in the search index; MFDS is the acting authority for every permit and approval provision quoted here.

제3조(정의) 1. "인체조직"이라 함은 ... 가. 뼈ㆍ연골ㆍ근막ㆍ피부ㆍ양막ㆍ인대 및 건 || 제4조(적용범위) ... 다만, 다음 각호의 1은 제외한다. 1. 자가이식용 조직 2. 「약사법」, 「의료기기법」, 그 밖에 다른 법령의 적용을 받는 품목류 또는 품목 || 제13조(조직은행의 허가 등) ①조직은행을 설립하고자 하는 자는 대통령령이 정하는 시설ㆍ장비ㆍ인력ㆍ품질관리체계 등을 갖추고 총리령으로 정하는 바에 따라 식품의약품안전처장의 허가를 받아야 한다. || 제17조(조직의 수입) ①조직은행외의 자는 조직을 수입하여서는 아니된다. ② 조직을 수입하려는 조직은행의 장은 총리령으로 정하는 바에 따라 조직마다 식품의약품안전처장의 승인을 받아야 한다. || Official English (law.go.kr elaw, MST 259169): "Article 17 (Import of Tissues) (1) No one, other than tissue banks, may import tissue. (2) The head of a tissue bank intending to import tissues shall obtain approval for each tissue from the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister." and "Article 4 (Scope of Application) ... Provided, That any of the following shall be excluded: 1. Tissue for self-transplantation; 2. Types of items or items governed by the Pharmaceutical Affairs Act, the Medical Devices Act, and other statutes." || 규칙 제16조(조직의 수입승인) ①... 4. 조직의 세부명칭 및 성상(性狀)을 확인할 수 있는 서류 ... 7. 수입승인 신청일 이전 최근 10년간 수출국 제조원의 해당 조직 관련 부작용 보고서 등 위해성 관련 서류

Requires, as transcribed: Two separate proofs, neither of which is a product licence. (1) INSTITUTION: Art. 13(1) — anyone establishing a tissue bank must hold the facilities, equipment, personnel and quality control system set by Presidential Decree and obtain a permit (허가) from MFDS. Art. 13(2) limits who may hold that permit to four categories only: medical institutions; non-profit corporations whose main purpose is tissue-related business; tissue processing operators (조직가공처리업자); tissue importers (조직수입업자). Art. 13-2 requires each tissue bank to appoint at least one medical manager holding a doctor's or dentist's licence. (2) THE TISSUE ITSELF: Art. 17(1) — no one other than a tissue bank may import tissue. Art. 17(2) — the head of a tissue bank must obtain approval from MFDS for EACH tissue (조직마다 ... 승인), and again for any change. Art. 17-2 — the exporting-country producer must then be separately registered with MFDS. Rule Art. 16(1) lists the dossier: documents proving the exporting producer/site is legally authorised in its own country to process and supply tissue (government- or public-body-issued only); documents identifying the type of tissue handled; documents confirming the detailed name and physical form/properties of the tissue (조직의 세부명칭 및 성상); the location of the recovering institution; labelling and package-insert content; ALL adverse-event/risk reports for that tissue from the exporting producer for the preceding 10 years; and documents on recovery, processing, storage and packaging environment control. On acceptance MFDS issues a 조직수입승인서 (tissue import approval certificate, Rule Form 6; electronic issuance permitted). Art. 10 additionally requires the tissue bank to test every tissue for transplant suitability before distributing it, to take a donor medical/medication history, and to query the Health Insurance Review and Assessment Service for the donor's medical and prescription history. Skin is expressly tissue: Art. 3(1)(a) — "뼈ㆍ연골ㆍ근막ㆍ피부ㆍ양막ㆍ인대 및 건" / official English "Bones, cartilage, fasciae, skin, amnia, ligaments, and tendons".

Does not require, as transcribed: NO product/item marketing authorisation (품목허가) of any kind. NO safety-and-efficacy dossier, NO clinical trial data, NO bioequivalence data — none of the Art. 31(10) Pharmaceutical Affairs Act data requirements apply, and none of the Medical Devices Act Art. 6(5) technical-document/clinical-data requirements apply. NO risk-class grading. NO GMP item conformity assessment. The Act does not review whether the tissue works; it reviews donor safety, processing conditions, traceability and the legitimacy of the foreign source. Art. 4 also makes the routes mutually exclusive: the Act does NOT apply to "1. Tissue for self-transplantation; 2. Types of items or items governed by the Pharmaceutical Affairs Act, the Medical Devices Act, and other statutes" — so if a product is licensed as a drug or a device it is out of this Act entirely, and vice versa.

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의료기기법. Official English title as published by law.go.kr: "MEDICAL DEVICES ACT". Law ID 009514. Current consolidated version: promulgated 2025-12-30, Act No. 21263, in force 2026-07-01. · 식품의약품안전처장 (Minister/Commissioner of Food and Drug Safety). The law.go.kr full-text record lists 소관부처 식품의약품안전처; the search index lists 보건복지부·식품의약품안전처.

제2조(정의) ① 이 법에서 "의료기기"란 사람이나 동물에게 단독 또는 조합하여 사용되는 기구ㆍ기계ㆍ장치ㆍ재료ㆍ소프트웨어 또는 이와 유사한 제품으로서 다음 각 호의 어느 하나에 해당하는 제품을 말한다. 다만, 「약사법」에 따른 의약품과 의약외품 및 「장애인복지법」 제65조에 따른 장애인보조기구 중 의지(義肢)ㆍ보조기(補助器)는 제외한다. || 제6조(제조업의 허가 등) ① 의료기기의 제조를 업으로 하려는 자는 식품의약품안전처장의 제조업허가를 받아야 한다. ② ... 제조하려는 의료기기에 대하여 다음 각 호의 구분에 따라 제조허가 또는 제조인증을 받거나 제조신고를 하여야 한다. 1. 인체에 미치는 잠재적 위해성이 낮아 ... 식품의약품안전처장이 정하여 고시하는 의료기기: 품목류별 제조허가, 제조인증 또는 제조신고 2. 제1호 외의 의료기기: 품목별 제조허가, 제조인증 또는 제조신고 ⑤ 제조업자는 ... 제조 및 품질관리체계 자료, 기술문서, 임상시험자료 등 필요한 자료를 식품의약품안전처장에게 제출하여야 한다. || 제15조(수입업허가 등) ① 의료기기의 수입을 업으로 하려는 자는 식품의약품안전처장의 수입업허가를 받아야 한다.

Requires, as transcribed: Two layers, both per-company AND per-item. (1) BUSINESS: Art. 6(1) manufacturing business permit (제조업허가) from MFDS; Art. 15(1) import business permit (수입업허가) from MFDS. Art. 6(4)/15(4) require the applicant to have the necessary facilities and a manufacturing-and-quality-management system (제조 및 품질관리체계) IN PLACE BEFORE applying. Art. 6(7) requires appointment of a quality responsible person (품질책임자). (2) THE PRODUCT: Art. 6(2)/15(2) — for each device the holder must obtain a manufacturing (or import) 허가 (approval), 인증 (certification), or file a 신고 (notification), graded by risk: for devices MFDS designates as low potential risk, per品目類 (item-class); for all other devices, 품목별 — per individual item. Art. 6(5)/15(6) — the applicant must submit to MFDS the quality-system data, the 기술문서 (technical document) and 임상시험자료 (clinical trial data) as required. Art. 3 requires MFDS to classify and designate every device by grade according to intended use and potential harm to the human body. Art. 28 requires conformity assessment of the manufacturing and quality management system. Art. 6(3)/15(3) require at least one item approval/certification/notification to be filed together with the business permit application. Art. 2(1) definition: instruments, machines, apparatus, MATERIALS (재료), software or similar products used on humans or animals for (1) diagnosing/treating/mitigating/handling/preventing disease, (2) diagnosing/treating/mitigating/correcting injury or disability, (3) examining/replacing/modifying structure or function, (4) contraception.

Does not require, as transcribed: NO tissue bank permit, NO donor consent regime, NO donor medical-history screening, NO HIRA donor-history query — none of the Human Tissue Act machinery applies (Human Tissue Act Art. 4(2) expressly excludes items governed by the Medical Devices Act). NO pharmacological-action evidence; Art. 2(1) expressly excludes drugs and quasi-drugs under the Pharmaceutical Affairs Act, so a product working by pharmacological action is not on this route. For low-risk devices there is NO approval at all — only 인증 (third-party-style certification) or a mere 신고 (notification), and Art. 6(10) obliges MFDS to accept a conforming notification. Clinical trial data is required only "as prescribed by Ordinance of the Prime Minister" per the item, not universally.

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약사법. Official English title as published by law.go.kr: "PHARMACEUTICAL AFFAIRS ACT". Law ID 001783. Version read: promulgated 2025-11-11, Act No. 21109. ENFORCEMENT DATE — CONFLICT, DO NOT PUBLISH A SINGLE DATE: the law.go.kr search index returns 시행일자 20260621 for this promulgation while the full-text service for the same record (MST 279725) returns 시행일자 20261112. A single Korean promulgation routinely carries staggered enforcement dates for different provisions, but which provision takes which date is NOT VERIFIED. · Jointly indexed to 보건복지부 (Ministry of Health and Welfare) and 식품의약품안전처 (MFDS); the full-text record lists 소관부처명 보건복지부. Every manufacturing, item-approval and import provision quoted here vests the power in 식품의약품안전처장 (Minister/Commissioner of Food and Drug Safety).

제2조(정의) 4. "의약품"이란 다음 각 목의 어느 하나에 해당하는 물품을 말한다. 가. 대한민국약전(大韓民國藥典)에 실린 물품 중 의약외품이 아닌 것 나. 사람이나 동물의 질병을 진단ㆍ치료ㆍ경감ㆍ처치 또는 예방할 목적으로 사용하는 물품 중 기구ㆍ기계 또는 장치가 아닌 것 다. 사람이나 동물의 구조와 기능에 약리학적(藥理學的) 영향을 줄 목적으로 사용하는 물품 중 기구ㆍ기계 또는 장치가 아닌 것 || 제31조(제조업 허가 등) ① 의약품 제조를 업(業)으로 하려는 자는 대통령령으로 정하는 시설기준에 따라 필요한 시설을 갖추고 총리령으로 정하는 바에 따라 식품의약품안전처장의 허가를 받아야 한다. ② 제1항에 따른 제조업자가 그 제조 ... 한 의약품을 판매하려는 경우에는 총리령으로 정하는 바에 따라 품목별로 식품의약품안전처장의 제조판매품목허가(이하 "품목허가"라 한다)를 받거나 제조판매품목 신고(이하 "품목신고"라 한다)를 하여야 한다. || 제42조(의약품등의 수입허가 등) ①의약품등의 수입을 업으로 하려는 자는 총리령으로 정하는 바에 따라 식품의약품안전처장에게 수입업 신고를 하여야 하며, 총리령으로 정하는 바에 따라 품목마다 식품의약품안전처장의 허가를 받거나 신고를 하여야 한다.

Requires, as transcribed: (1) BUSINESS: Art. 31(1) — manufacturing a drug as a business requires the facilities set by Presidential Decree and a permit (허가) from MFDS. Art. 42(1) — importing requires an import business notification (수입업 신고) to MFDS. Art. 42(3) — the importer must hold the premises/facilities set by Presidential Decree. (2) THE PRODUCT: Art. 31(2) — to sell a drug it has manufactured, the manufacturer must obtain, PER ITEM (품목별), a manufacture-and-sale item approval (제조판매품목허가, abbreviated 품목허가) from MFDS, or file an item notification (품목신고). Art. 42(1) — an importer must likewise obtain approval or file a notification 품목마다 (for each item). Art. 31(10) — where the item is a new drug or a drug designated by MFDS, safety and efficacy data must be submitted, including (per the enumerated categories) clinical trial data. Art. 31(12) — for a generic matching a new drug in active ingredient, content, route, indication and dosage, the specified data including bioequivalence data must be submitted. Art. 38-2 requires GMP conformity determination. Art. 2(4) definition: (a) items listed in the Korean Pharmacopoeia that are not quasi-drugs; (b) items used for the purpose of diagnosing, treating, mitigating, handling or preventing disease in humans or animals, other than instruments, machines or apparatus; (c) items used for the purpose of pharmacologically affecting the structure or function of humans or animals, other than instruments, machines or apparatus.

Does not require, as transcribed: NO tissue bank permit and none of the Human Tissue Act donor machinery (Human Tissue Act Art. 4(2) excludes items governed by this Act). NO device risk-class grading. Art. 31(7) — where a drug/device combination's PRINCIPAL function is that of a medical device and it is approved under the Medical Devices Act, it is DEEMED to have the drug item approval, so it need not be licensed twice; Medical Devices Act Art. 6(6)/15(5) provide the mirror-image rule. Art. 31(6) — investigational drugs and other items set by Ordinance of the Prime Minister may be manufactured without a manufacturing permit or item approval. Art. 42(2) — an importer may import without per-item approval for raw materials used in its own manufacturing, and for investigational drugs and other items set by Ordinance.

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화장품법. Official English title as published by law.go.kr: "COSMETICS ACT". Law ID 002015. Version read in full: promulgated 2025-04-01, Act No. 20901, in force 2026-04-02. Later promulgated amendments not yet in force at 2026-08-02, all confirmed from the same source: Act No. 21302 (promulgated 2025-12-30; staggered enforcement 2026-12-31, 2028-01-01, 2029-01-01); Act No. 21604 (promulgated 2026-04-28, in force 2027-04-29); Act No. 21709 (promulgated 2026-05-26, in force 2026-11-27). · 식품의약품안전처장 (Minister/Commissioner of Food and Drug Safety). Sole ministry on the record: 소관부처명 식품의약품안전처. Routine advertising enforcement is carried out by the regional offices — e.g. 서울지방식품의약품안전청 (Seoul Regional MFDS).

제2조(정의) 1. "화장품"이란 인체를 청결ㆍ미화하여 매력을 더하고 용모를 밝게 변화시키거나 피부ㆍ모발의 건강을 유지 또는 증진하기 위하여 인체에 바르고 문지르거나 뿌리는 등 이와 유사한 방법으로 사용되는 물품으로서 인체에 대한 작용이 경미한 것을 말한다. 다만, 「약사법」 제2조제4호의 의약품에 해당하는 물품은 제외한다. || 제3조(영업의 등록) ① 화장품제조업 또는 화장품책임판매업을 하려는 자는 각각 총리령으로 정하는 바에 따라 식품의약품안전처장에게 등록하여야 한다. || 제4조(기능성화장품의 심사 등) ① 기능성화장품으로 인정받아 판매 등을 하려는 화장품제조업자, 화장품책임판매업자 ... 또는 총리령으로 정하는 대학ㆍ연구소 등은 품목별로 안전성 및 유효성에 관하여 식품의약품안전처장의 심사를 받거나 식품의약품안전처장에게 보고서를 제출하여야 한다. ② 제1항에 따른 유효성에 관한 심사는 제2조제2호 각 목에 규정된 효능ㆍ효과에 한하여 실시한다.

Requires, as transcribed: Registration of the BUSINESS, not authorisation of the PRODUCT. Art. 3(1) — a person intending to run a cosmetics manufacturing business (화장품제조업) or a cosmetics responsible-distribution business (화장품책임판매업) must REGISTER (등록) with MFDS, and re-register on change of significant matters. Art. 3(2) — the manufacturer must meet the facility standards set by Ordinance of the Prime Minister. Art. 3(3) — the responsible distributor must have quality-management and post-marketing safety-management standards and must appoint a 책임판매관리자 (responsible distribution manager). Art. 3-2 — a custom cosmetics seller files a notification (신고). The ONLY product-level pre-market step is Art. 4(1): to sell a product as a FUNCTIONAL cosmetic (기능성화장품), the manufacturer, responsible distributor or a designated university/institute must, PER ITEM (품목별), either undergo an MFDS review (심사) of safety and efficacy or submit a report (보고서) to MFDS. Art. 4(2) limits that efficacy review strictly to the five statutory categories in Art. 2(2): skin whitening; wrinkle improvement; tanning or UV protection; hair colour change/removal/nourishment; and prevention or improvement of dryness, splitting, loss or keratinisation caused by weakened skin or hair function.

Does not require, as transcribed: NO product marketing authorisation, NO item licence, NO item number for an ordinary (non-functional) cosmetic — the product simply goes to market once the business is registered and labelling, safety standards (Art. 8) and safety-container rules (Art. 9) are met. NO clinical trial data. NO GMP item approval. NO risk-class grading. NO tissue bank permit. Critically, this route CANNOT carry an injectable. Art. 2(1) defines a cosmetic as something "applied to, rubbed on, sprayed on the human body or used by similar methods" whose "action on the human body is MILD" (인체에 대한 작용이 경미한 것), and expressly excludes anything falling within the definition of a drug under Pharmaceutical Affairs Act Art. 2(4). MFDS has stated the point directly in a press release headed "피부 내 주입은 의약품ㆍ의료기기만 가능해요!" (Injection into the skin is possible only with drugs or medical devices), 등록일 2023-01-05, https://www.mfds.go.kr/brd/m_99/view.do?seq=46938.

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