Regulatory identity — Korea
This document is technical information about materials. It does not recommend any procedure or product.
Regulatory identity by market
How are ECM-active materials regulated in Korea?
Of the 15 materials in this atlas, 8 could be classified in Korea from public sources — 7 as medical devices, 1 as drugs. The remaining 7 could not be established and are marked as such rather than inferred.
How each material in this atlas is classified in Korea, with the legal basis where a classification could be established.
| Material | Classification | Note | Basis |
|---|---|---|---|
| Animal-derived collagen | unclassified | Not established from public sources as of the revision date below. Classification depends on the presentation and claim rather than on the protein itself, and animal-tissue sourcing may bring additional requirements. | — |
| Botulinum toxin type A | drug | Regulated as a medicine under the Pharmaceutical Affairs Act, not under the medical device framework that covers the other materials in this reference. Advertising rules for prescription medicines are correspondingly stricter. | Legal text |
| CaHA (Calcium hydroxylapatite) | medical-device | Injectable forms follow the tissue-repair biomaterial route in the MFDS device classification notice. | Legal text |
| Crosslinked HA (Crosslinked hyaluronic acid) | medical-device | Injectable forms follow the tissue-repair biomaterial route in the MFDS device classification notice. | Legal text |
| Exosomes (Extracellular vesicles) | unclassified | Not established from public sources as of the revision date below. Preparations derived from cultured cells do not map cleanly onto the cosmetic, device and drug categories used elsewhere in this table. | — |
| hADM (Human acellular dermal matrix) | unclassified | Donor-derived human tissue is handled under the Act on Safety and Management of Human Tissue, a pathway separate from the cosmetic, device and drug classifications used elsewhere in this table. The lane differs in kind, not in tier, so none of the three labels applies. | Legal text |
| Non-crosslinked HA (Non-crosslinked hyaluronic acid) | unclassified | Not established from public sources as of the revision date below. Classification appears to depend on the presentation and the claim rather than on the polysaccharide itself. | — |
| PCL (Polycaprolactone) | medical-device | Injectable forms follow the tissue-repair biomaterial route in the MFDS device classification notice. | Legal text |
| PDLLA (Poly-D,L-lactic acid) | medical-device | Injectable forms follow the tissue-repair biomaterial route in the MFDS device classification notice. Topical formulations may fall under cosmetics, so classification depends on presentation. | Legal text |
| PDO (Polydioxanone) | medical-device | Absorbable thread and suture products follow the device route in the MFDS classification notice. | Legal text |
| PDRN (Polydeoxyribonucleotide) | unclassified | Unlike the particulate biostimulators on this site, nucleotide-derived agents are marketed in more than one regulatory lane, and the route differs with presentation and intended use. A single classification could not be established from public sources as of the revision date below; settling it requires product-level records from the national authority. | — |
| PLGA (Poly(lactic-co-glycolic acid)) | medical-device | Resorbable thread and suture products follow the device route in the MFDS classification notice. This is the form in which the copolymer is established in aesthetic practice. | Legal text |
| PLLA (Poly-L-lactic acid) | medical-device | Injectable forms follow the tissue-repair biomaterial route in the MFDS device classification notice. | Legal text |
| PN (Polynucleotide) | unclassified | Unlike the particulate biostimulators on this site, nucleotide-derived agents are marketed in more than one regulatory lane and the route differs with presentation and intended use. A single classification could not be established from public sources as of the revision date below. | — |
| rhCollagen (Recombinant human collagen) | unclassified | Not established from public sources as of the revision date below. Classification is likely to depend on the presentation and the claim rather than on the protein itself. | — |
COS cosmetic · MD medical device · RX drug · — not established in public sources