Korea License Holder

FAQ: Korea License Holder – Breaking free from distributors

Local Representation in Korea Appointing a Korea license holder is to be taken seriously. If you don’t, you

Local Representation in Korea

Appointing a Korea license holder is to be taken seriously. If you don’t, you may end up in a dead end with products you cannot put on the market. Here below we get into the details of what is a license holder, its responsibilities and other topics.

It came from the recent surge of questions we got from our subscribers.

We will also start to create a constantly updated resource page DEDICATED to Korean market which for instance, will include: FAQ like this one, video, presentations, links, etc…

The want the content we put on the resource page to be evergreen so that you can come back as much as needed.

Regarding the License Holder now, here is the FAQ.

 

Question 1 – What is a license holder ?

Answer – A license holder is the equivalent of a European Representative or a US agent. It is an established place of business in Korea responsible to place the product on the market. It may be also involved in the registration of the product but it’s not an obligation. The license holder is the owner of the product license. From that perspective, it has legal responsibilities locally (penalties will apply in case of infraction).

Question 2 – What are the duties of a license holder?

Answer – The license holder is responsible for the following:

  • Customs clearance – though it can be done by the distributor through a contract
  • Report any design/manufacturing changes to the MFDS
  • Communicate with MFDS in case of incident, adverse event, recalls
  • Communicate with manufacturer in case of recalls, advisory notice

Question 3 – Is the importer the license holder?

Answer – The importer is usually the license holder but as said in Question 2, the clearance and inspection can be subcontracted to the distributor

Question 4 – How to change the license holder?

Answer – There are 2 cases:

  • The former license holder is not willing to cooperate: the products have to be re-registered with the new license holder
  • The former license holder is willing to cooperate: the transfer can be done by establishing a contract between the two license holders and declaring the change to the MFDS. A couple of weeks are needed for the change to be effective

Question 5 – How to become license holder?

Answer – To become a license holder, a company needs a registered place of business in Korea. It is also required to have a quality manager as a full time employee.

Question 6 – How about products which I’m distributing but I’m not the manufacturer? What to deliver as KGMP certificate?

Answer – Whoever is importing products, must provide a valid product license AND a KGMP certificate. For class 1 products, since a KGMP certificate is not required only the product license is necessary.

Question 7 – What are the different options for my products licensing?

Answer – There are 3 options summarized below with pros and cons:

  • Option A: Appoint the distributor
  • Option B: Appoint a specialist of regulatory affairs in Korea
  • Option C: Establish a branch/subsidiary in Korea

See the chart below for a quick comparison between the different options:

 

Options for local representation in Korea

  Distributor Dedicated License Holder Branch/Subsidiary
Ease in Handling Yes No No
Experiencein registration Yes Yes No
Cost Yes No No
Flexibility No Yes Yes
Post-Market No Yes Yes
Ownership No No Yes
Total 3 Yes 3 Yes 3 Yes

Source: Fictitious data, for illustration purposes only

 

Each of the above option is valid depending on your priorities.

The main driver for companies to switch from Option A to B is to separate the commercial part from the regulatory part and being more flexible with their distributors.

The move from Option A (or B) to C is usually driven by the goal to get complete ownership of the process.

 


If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.

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About nicolas

My name is Nicolas Clary, I'm the founder and CEO of Kobridge Consulting Ltd. in 2006 when I met my wife in Korea I had no idea it would lead me to this. At that time I was already a consultant and regulatory expert for Medtech companies. I was also an auditor for the French Notified Body LNE. In 2007 I decided to move to Korea to establish a consulting business there. At first I was like most my actual clients : completely lost. It took me a lot of time to understand all the regulatory processes in Korea and fortunately I was lucky enough to find the right people. I am much better now at understanding my clients' needs because I've been in their shoes before. I usually say that I'm a translator. Understanding different regulations helps to explain certain requirements (here Korea vs Europe or US). I can also translate the needs of regulatory professionals to sales professionals and vice versa.