I. Verification by Standard Certificate Form

1	Types of English Certificate of Medical Products

The typical English certificates of medical products issued by the MFDS are as follows:

□ Drugs

① Certificate of a Pharmaceutical Product (CPP)

② Certificate of Free Sales (FSC) - Drug

③ Certificate of Free Sales (FSC) - Quasi-drug

④ Certificate of Drug Master File (DMF) Registration

⑤ Certificate of Import Business License – Drug & Quasi-drug

⑥ Certificate of GMP Compliance of a Manufacturer

⑦ Certificate of Good Manufacturing Practice

⑧ Written Confirmation (GMP) for Active Substances

⑨ Certificate of Pharmaceutical Manufacturing License

⑩ Certificate of Quasi-drug Manufacturing License

□ Medical Devices

① Certificate of Manufacturing Declaration/Certification/Authorization

② Certificate of Import Declaration/Certification/Authorization

③ Certificate of Manufacturing Declaration/Certification/Authorization for Exported Items

④ Certificate of Import Declaration/Certification/Authorization for Exported Items

2	Verification of Certificate Authenticity

The authenticity of the issued certificates can be verified with the following: authenticity mark, document verification number, signature of responsible person, and MFDS watermark, etc.

□ Drugs

Authenticity Mark

Agency & Address of Issue

Document Verification Number (16 digits)

Certificate Number (10

Date of Issue & Certificate Number

Responsible Person

Signature

Position

Division

Department/Bureau

Barcode for Authenticity Verification

MFDS Watermark

①

②

③

④

⑤

⑥

⑦

⑧

① Authenticity Mark: The authenticity mark  is found on the top left corner of the first page where “authenticity (진본 in Korean)“ is specified.

② Document Verification Number: As a 16-digit code composed of alphabetical letters and numbers, it is found on the top right corner of the certificate. The document verification number is also used for authenticity verification on the website.

③ Agency & Address of Issue: The responsible agency either MFDS or one of *6 Regional Offices of Food and Drug Safety that issued the certificate for certain product; and its address are indicated on the top of the first page or bottom of the last page of the certificate.

* Seoul, Busan, Gyeongin, Daegu, Gwangju, and Daejeon

④ Certificate Number: As a 10-digit code composed of alphabetical letters and numbers, it is found on the center of the first page of the certificate.

⑤ MFDS Watermark: As the Korean government emblem, the MFDS Watermark   is found on the right in the middle of the certificate.

⑥ Date of Issue & Certificate Number: Date of issue and the certificate number indicated in ④ are found on the bottom of the certificate.

⑦ Responsible Person, Signature, and Responsible Department/Bureau: Name, signature, department/bureau, and agency of the responsible person are found on the right bottom of the certificate.

⑧ Barcode for Authenticity Verification: Three (3) 2D barcodes  are found on the bottom of each page of the certificate. This barcode is also used for authenticity verification through the mobile application.

□ Medical Devices

① Authenticity Mark: The authenticity mark  is found on the top left corner of the first page where “authenticity (진본 in Korean)“ is specified.

② Document Verification Number: As a 16-digit code composed of alphabetical letters and numbers, it is found on the top right corner of the certificate. The document verification number is also used for authenticity verification on the website.

③ Address: The MFDS address is found on the top right side of the certificate.

④ Certificate Number: As a 16-digit number, it is found on the top left side of the certificate.

Exporting(certifying) country: Indicates the country you export.

Importing(requesting) counntry: Indicates the country you want to import.

⑤ MFDS Watermark: As the Korean government emblem, the MFDS Watermark   is found on the right in the middle of the certificate.

⑥ Date of Issue: Date of issuing the certificate is found on the top right side of the certificate.

⑦ Responsible Person, Signature, and Responsible Department/Bureau:  Name, signature, department/bureau, and agency of the responsible person are found on the right bottom of the certificate.

⑧ Barcode for Authenticity Verification: This barcode  is found on the bottom of each page of the certificate. This barcode is also used for authenticity verification through the computer program.

II. Verification on the Website

The authenticity of the certificate can be verified on the representative websites of MFDS.

Type a URL “www.mfds.go.kr/eng” in the address box to enter into the MFDS English website. You can see the ”Certificate Verification” under our works at the bottom right corner as below.

Clicking on the “Drugs/Medical Devices” it is connected directly to the “Certificate Verification.” Alternatively, You can visit the drugs (https://nedrug.mfds.go.kr) and medical device (https://emedi.mfds.go.kr) websites, respectively, and verify the authenticity through the certificate number and document verification number.

□ Drugs

① Go to the Drug Safety World (Drug Integrated Information System) website (https://nedrug.mfds.go.kr/).

② Click “Certificate Verification” on the bottom left corner.

* You may directly go to the website (https://nedrug.mfds.go.kr/pbp/CCBSC02/certificate) specified on the bottom of the certificate.

③ Enter the 16-digit Document Verification Number written on the top right corner of the certificate into the box of “VERIFICATION NO.‘’ Then click the  button.

④ Compare the search result with the content of the original certificate.

⑤ If the Document Verification Number is not correct or the certificate is not authentic, a popup showing “There is no matching certificate.” is displayed.

□ Medical Devices

① Go to the Electronic Medical Device Civil Service website (https://emedi.mfds.go.kr).

② Click “Verifying authenticity of certificates” on the bottom left corner.

* You may directly go to the website(https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do) specified on the bottom of the certificate.

③ Enter the 16-digit Document Verification Number written on the top right of the certificate, click on the “Search” button.

④ Compare the search results with the content of the orginal certificate.

⑤ If the Document Number or the Certificate Number is not correct, or the certificate is not authentic, a popup showing “Please enter your Document Number” is displayed.