Presented by Nicolas Clary 
(Kobridge Consulting Ltd.)
Agenda : 
Definitions 
Duties of parties involved 
Changing representation 
Becoming license holder 
Distributing products...
Definitions 
Korean License 
Holder 
European 
Representative 
US Agent
Definitions 
License holder = established 
place of business in Korea 
responsible to place the product 
on the market
Definitions 
License holder can be involved 
in the registration of the 
product (not an obligation)
License 
Holder = 
owner of 
product 
licenses
Legal 
responsibi 
lities - 
penalties
Duties of the parties involved 
What are the License holder 
duties ?
Customs 
Clearance
Duties of the parties involved 
Importer = License holder 
BUT 
Clearance and inspection can be 
subcontracted to distribu...
Duties of the parties involved 
Report any 
design/manufacturing changes 
to the MFDS
Duties of the parties involved 
Communication 
Channel for 
Recalls, events… 
Manufacturer 
License 
Holder 
MFDS
Changing license holder 
Cooperative Mode Non-cooperative mode 
Contract 
between 
former and 
new license 
holder 
All pr...
Changing license holder 
Cycle time for the transfer: 
A couple of weeks
Becoming a license holder 
2 things are needed
Place of 
business 
in Korea
QA 
manager
Impact on KGMP 
KGMP also has to be 
transferred. 
Can be done at the same time 
OR after product license 
transfer
Different options 
Distributor 
• Ease in 
handling 
• Experience 
• Cost 
RA specialist 
• Experience 
• Flexibility 
• P...
Breaking 
free from 
the 
distributor
How can we help ? 
We provide all submitted 
documents to our clients 
In our contract we make sure 
any change is possibl...
The future ? 
We want to provide our clients 
a “one-stop” service for them to 
establish a branch in Korea and 
then beco...
Nicolas Clary 
Kobridge Consulting 
+82 2 3450 1690 
Nicolas.clary@kobridgeconsulting.com 
www.kobridgeconsulting.com
Local representation in South Korea
Local representation in South Korea
Local representation in South Korea
Local representation in South Korea
Local representation in South Korea
Local representation in South Korea
Local representation in South Korea
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Local representation in South Korea

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Presentation about license holder in Korea for medical devices manufacturers. Folling sections are covered:
Definitions
Duties of parties involved
Changing representation
Becoming license holder
Distributing products
Impact on KGMP
Different options

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  • Local representation in South Korea

    1. 1. Presented by Nicolas Clary (Kobridge Consulting Ltd.)
    2. 2. Agenda : Definitions Duties of parties involved Changing representation Becoming license holder Distributing products Impact on KGMP Different options
    3. 3. Definitions Korean License Holder European Representative US Agent
    4. 4. Definitions License holder = established place of business in Korea responsible to place the product on the market
    5. 5. Definitions License holder can be involved in the registration of the product (not an obligation)
    6. 6. License Holder = owner of product licenses
    7. 7. Legal responsibi lities - penalties
    8. 8. Duties of the parties involved What are the License holder duties ?
    9. 9. Customs Clearance
    10. 10. Duties of the parties involved Importer = License holder BUT Clearance and inspection can be subcontracted to distributor
    11. 11. Duties of the parties involved Report any design/manufacturing changes to the MFDS
    12. 12. Duties of the parties involved Communication Channel for Recalls, events… Manufacturer License Holder MFDS
    13. 13. Changing license holder Cooperative Mode Non-cooperative mode Contract between former and new license holder All products have to be registered again
    14. 14. Changing license holder Cycle time for the transfer: A couple of weeks
    15. 15. Becoming a license holder 2 things are needed
    16. 16. Place of business in Korea
    17. 17. QA manager
    18. 18. Impact on KGMP KGMP also has to be transferred. Can be done at the same time OR after product license transfer
    19. 19. Different options Distributor • Ease in handling • Experience • Cost RA specialist • Experience • Flexibility • Post-market Branch • Flexibility • Post-market • Ownership
    20. 20. Breaking free from the distributor
    21. 21. How can we help ? We provide all submitted documents to our clients In our contract we make sure any change is possible
    22. 22. The future ? We want to provide our clients a “one-stop” service for them to establish a branch in Korea and then become license holder
    23. 23. Nicolas Clary Kobridge Consulting +82 2 3450 1690 Nicolas.clary@kobridgeconsulting.com www.kobridgeconsulting.com

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