Regulatory Compliance Service - Medical Device

 

Importing Medical Device Procedure with K-GMP Service

STEP 1. Reviewing Device Code & Class and preparing documents
Check point!
1) Medical device code and class of product under 『The Medical Device Act』 of MFDS.
2) Documents necessary for Medical Device notification or registration should be prepared

K-GMP Consulting!
1) Review of medical device code and class
2) Device labelling under MFDS regulation
3) Guide to documents required for regulation
4) Guide to process for notification or registration

STEP 2. Foreign establishment registration
Check point!
1) Foreign establishment that manufactures medical device sold in Korea must register to the MFDS.

K-GMP Consulting!

1) Foreign establishment registration

2) Foreign establishment registration renewal

- Valid: 1 year

STEP 3. Medical device notification or registration
Check point!

1) The documents to be prepared are  different depending on the code and class of the medical device.

2) In some cases, documents may be simplified when submitted as an 'equivalent product'.

K-GMP Consulting!

1) Technical file(or STED) guidance (if applicable)

2) GMP guidance (if applicable)

3) Clinical trail guidance (if applicable)

4) UDI registration (necessary)

5) Guide to test report, validation, record and documents if required

K-GMP is advising you at every stage your product development and helping you towards innovation in total efficiency.

If you have further questions, please contact to K-GMP.