[GMP Update] Standardising Application Documents (April 2024).

MFDS advised that the following documents would be requested in addition to the application form and attachments required under the medical device GMP standards.

[Additional Documents]
① Consent to collection, use and disclosure of personal information
② Copy of the business registration certificate

[Documents Required Where Applicable]

Classification enquiry response where the product group is unclear; copy of the GMP certificate for transfers or similar changes

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=14&bbsSno=1339