Before a PO is issued, your regulatory affairs team will request Certificates of Analysis, MSDS sheets, FDA approval letters, KGMP certifications, and batch-verification records. This portal centralizes those artifacts — request access below to download the complete file for any SKU in the Dermal Market catalog.
Each panel links to the document family most often cited in a vendor qualification file. Files are revision-controlled and tied to a specific manufacturing lot; older revisions remain on file for audit purposes.
Per-lot laboratory report covering sterility, endotoxin, pH, viscosity, HA concentration, and particulate. Issued by the manufacturer's QC lab and counter-signed by the export documentation team.
Request CoA archive16-section SDS aligned to GHS, covering composition, first-aid measures, handling, storage, and disposal guidance for every dermal filler, skin booster, and adjunct in the catalog.
Request SDS files510(k) clearance letters, device classification references, and establishment registration records for products marketed under FDA oversight. Provided per SKU on request.
Request FDA file setKorean Good Manufacturing Practice certificates for each manufacturing facility, issued by the Ministry of Food and Drug Safety (MFDS) and renewed on the regulatory cycle.
Request KGMP recordsDeclaration of Conformity, EU MDR technical documentation summaries, and Notified Body certificates for products distributed into the European Union and EEA jurisdictions.
Request CE / MDR fileLot number lookup file plus the serialized shipping record, customs HS classification, and receiving-recommendation letter tied to every individual production batch.
Open batch lookupAuthentic Korean dermal filler SKUs under full documentation
Registered manufacturing facilities audited under KGMP
Destination jurisdictions supplied under documented export files
Years of continuous export documentation history
Procurement teams in different jurisdictions need to see different authority marks. Dermal Market maintains an active documentation file under each of the four regimes below — confirm coverage for your destination country before issuing a PO.
Products marketed under US jurisdiction carry the appropriate 510(k) clearance or device classification reference, and the establishment is registered with the FDA. Facility registration numbers, device listings, and the importer of record details are provided in the qualification file.
Declaration of Conformity, Notified Body certificates, and the EU MDR technical file summary for every CE-marked device.
Korean Good Manufacturing Practice certification issued by the Ministry of Food and Drug Safety for each contracted facility.
Country-level registration dossiers for the markets we regularly ship into — including health authority notification letters, local distributor appointments, and product registration certificates where required. If your destination market is not listed, our regulatory team will scope the registration timeline as part of the wholesale application.
Each batch leaving a Korean manufacturing line generates a chain of custody that travels with the shipment. Below is the documentation timeline a single lot passes through between line release and clinic receipt.
The production lot is released at the Korean facility under the KGMP quality system. The batch record, line clearance, and in-process control data are signed by the Qualified Person and archived in the manufacturer's documentation system.
Batch record · Line clearance · In-process controlsThe retained reference sample is dispatched to an accredited third-party laboratory for sterility, endotoxin, and composition testing. The resulting Certificate of Analysis is signed, dated, and attached to the lot file.
Certificate of Analysis · ISO 17025 lab reportLot numbers are serialized against the shipment, the commercial invoice is reconciled, and the export packing list is filed. Cold-chain temperature loggers are paired to the consignment for transit verification.
Commercial invoice · Packing list · Cold-chain logThe shipment clears customs under the documented HS classification. The receiving dock cross-references the lot number against the batch record before stock is released into inventory.
Customs declaration · Receiving checklist · Stock-release sign-offUse this four-step protocol in your receiving area to independently confirm that a Dermal Market shipment is the lot documented on the accompanying paperwork. Any discrepancy should be reported to your account manager before stock is released.
Cross-reference the lot number printed on each unit carton against the lot number on the Certificate of Analysis and the commercial invoice. The three values must match exactly — any deviation indicates a documentation break.
Each carton carries a serialized QR code linking to the manufacturer's batch record portal. Scanning the code should return the same lot number, expiry date, and product description as the printed label.
Open one unit per lot and confirm the product insert, language set, and sterile barrier indicators match the SKU description on the CoA. Damaged sterile barriers must be quarantined regardless of paperwork status.
Sign and date the receiving checklist, file the CoA and MSDS against the lot number in your quality system, and only then release the stock into your saleable inventory. Records must be retained per your local regulatory requirement.
Need the qualification file before issuing a purchase order?
Request wholesale access Speak with compliance team