Foreign GMP Certificate Requirement

Foreign manufacturers wishing to supply devices to Korea do not need a Korean manufacturer licence, but must provide evidence of GMP compliance. Two routes:

Route 1 — MFDS overseas inspection (해외제조소 현지실사)

1. Korean importer submits overseas inspection application to MFDS
2. MFDS schedules inspection (with manufacturer cooperation)
3. MFDS inspectors visit the foreign site
4. If satisfactory: Foreign GMP Recognition Certificate (해외제조소 인증) issued

Route 2 — ISO 13485 certificate recognition (most common)

MFDS recognises ISO 13485 certificates from IAF MLA-accredited certification bodies. Requirements:

• Certificate must be current
• Certificate scope must cover the specific products being applied for
• Certification body must be IAF MLA member-accredited

Route comparison

Factor	MFDS overseas inspection	ISO 13485 recognition
Cost	Higher (inspector travel)	Lower
Timeline	6–12 months	Faster (if certificate scope matches)
Certainty	High	Depends on certificate scope matching

Related pages

• Recognised foreign GMP certificates · MFDS overseas inspection program · Korean agent obligations