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INDUSTRY 02 · Medical/Pharma

Medical device & pharmaceutical export documents,
from translation to certification in one go

We prepare 17 types of export documents — CFS (Certificate of Free Sale), GMP, ISO 13485, and more — end to end: translation → notarization → apostille/embassy legalization → international delivery. Usually 3–5 business days, or 5–15 business days including embassy legalization.

CFSGMPISO 13485CE certificationManufacturing licenseInspection Report / Certificate of AnalysisManufacturing Certificate
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Medical/Pharma service summary
180+
Countries served
17 types
Eligible documents
3 days~
Average turnaround
9,570+
Cumulative corporate clients
WHYWhy is preparing medical device & pharmaceutical export documents difficult?Click to collapse/expand▾
1
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Requirements differ by country

Regulatory systems differ by country — FDA, CE (MDR), NMPA — so the same product needs different documents.

2
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Issuing bodies vary widely

Each document is issued or held by a different body — the MFDS, notified bodies (NB), testing labs, and more.

3
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Certification methods differ

You must distinguish countries where an apostille is enough from those that also require embassy certification.

4
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Registration-schedule pressure

Translation, notarization and certification must be completed in order to meet local licensing or bidding deadlines.

SUMMARYMedical & pharma export document legalization in 30 secondsClick to collapse/expand▾

To export medical devices & pharmaceuticals You must prepare the certificates required by the importing country (CFS, GMP, ISO 13485, etc.) and submit them after notarization and an apostille or embassy legalization. For Apostille Convention member countries, one confirmation by the Ministry of Foreign Affairs is enough; for non-member countries, embassy legalization in Korea is also required after the Ministry's confirmation.

ItemDetails
Key documents17 types incl. CFS, GMP, ISO 13485, CE certification, manufacturing licenses, and inspection reports
Certification route(Documents on hand) Translation → notarization → apostille, or MOFA confirmation + embassy certification
Processing timeApostille 3–5 business days / 5–15 business days incl. embassy certification
PaymentExport voucher settlement available · direct corporate payment
DOCUMENTSSelect required documents — apply with per-document options

Select a document to view its product details. If several products are available, choose the country and processing option first. Add items to your cart on the product details page.

NATIONCertification methods for major export countries at a glanceClick to collapse/expand▾
🇻🇳 Vietnam
MOFA certification + embassy confirmation
  • CFS · GMP · Power of attorney (embassy legalization)
  • For medical device & pharmaceutical registration with the Ministry of Health (MOH)
  • Not party to the Apostille Convention — certification at the Vietnamese Embassy in Korea
🎧 Asia inquiries02-775-8630
🇨🇳 China
Apostille
  • CFS · GMP — for NMPA registration
  • Apostille Convention took effect Nov 2023, simplifying procedures
  • Some bodies require additional notarization — we handle prior confirmation
🎧 China (separate line)02-318-8868
🇺🇸 USA
Apostille / notarized translation
  • FDA facility registration · 510(k)/listing evidence
  • English documents often suffice with notarized translation
  • Requirements vary by state and agency — verify in advance
🎧 North America inquiries02-747-2185
🇪🇺 EU
Apostille
  • CE (MDR/IVDR) technical files · ISO 13485
  • Frequent demand for notarizing EU representative (EC REP) contracts
  • Common procedure across member states — Germany, France, etc.
🎧 Europe inquiries02-774-2185
🇦🇪 UAE
MOFA certification + embassy confirmation
  • MOHAP registration — CFS · GMP legalization required
  • Non-apostille — certification at the UAE Embassy in Korea
  • Similar procedures in nearby Middle East countries (Kuwait, etc.)
🎧 Middle East inquiries02-774-2185
🌏 Other countries
Check by country
  • Support for 180+ countries — Latin America, Southeast Asia, Africa, etc.
  • We guide the procedure depending on Convention membership
  • Just tell us the country and we will guide you within 1 business day
🎧 General inquiries02-774-2185
ⓘ The actual required document names and procedures can vary depending on the destination country and receiving body, so prior confirmation is important.
PROCESSProcess — one-stop by stage
📑
Issuance
Original Issuance
Full service
🌐
Translation
Certified Translation
(in English, etc.)
✒️
Notarization Commission
Notarization of translation · copy
if needed
🏛️
Apostille
/ Consular Confirmation
By country of submission
Authentication
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Embassy Certification
For non-Convention countries
if needed
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Delivery
Domestic & Overseas
Secure Delivery
PRICEEstimated cost · time (for reference)
Issuance + Translation
Varies by document
Per 1 document · 2–3 business days
Issuance + Translation + Embassy Certification
+$50~
Submission to non-Convention country · 5–10 business days
* 국가·서류 종류·급행 여부에 따라 달라지며, 정확한 금액은 견적 상담 시 안내됩니다. (아포스티유/영사확인 US$25, 대사관 인증은 국가별 상이 · 수출바우처 정산 가능)
FAQFAQ
Q Is a CFS (Certificate of Free Sale) always required when exporting medical devices and pharmaceuticals?▾
Many countries — Vietnam, the Middle East, Latin America — require a CFS when registering medical devices and pharmaceuticals. Depending on the country, an apostille or embassy legalization is also needed; we handle everything from translation to legalization based on the documents you already hold.
Q What is the difference between an apostille and embassy certification?▾
An apostille is a procedure completed with a single MOFA confirmation between Convention member countries. For non-member countries, after MOFA confirmation you must additionally obtain certification from that country's embassy in Korea.
Q How long does processing take?▾
Translation, notarization and apostille usually take 3–5 business days; including embassy certification, 5–15 business days depending on the country. Urgent processing is also available on request.
Q Can I pay with an export voucher?▾
Yes. The Korea Integrated Civil-Affairs Center is an export-voucher performing agency, so translation and certification costs can be settled with a voucher.
Q Can it proceed even if the original documents are overseas?▾
Yes. Local apostille and consular certification of documents issued abroad can also be handled remotely through our network in 180 countries.
GUIDEGuides worth viewing together
GUIDEEssential for pharma exports — complete guide to apostille & embassy legalization of GMP documents
GUIDEVietnam medical device registration — guide to embassy legalization of CFS, GMP, and powers of attorney
NEWSChina joins the Apostille Convention — what changed for medical device & pharma export documents
?
Not sure which documents or steps you need?
Just tell us the document name and destination country, and a specialist will provide a quote and schedule within 1 business day.
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1:1 consultation
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02-774-2185
Weekdays 09:00–18:00