We offer “In-country Caretaker Service” for medical device exporters to Korea seeking direct control over their product licenses and reimbursement coverage decision process with local authorities rather than relying on local distributors, so you can secure long-term stability in product supply to local customers.

The essence of our In-country Caretaker Service is that we act as your local third-party consultant to obtain and hold import licenses and to host reimbursement pricing authorization granted to your products by Korean authorities. Upon your authorization, we permit your local distributors or customers clear your export shipments to Korea or seek reimbursements based on the product licenses and reimbursement approvals we locally maintain on your behalf.

Here are some of the key advantages you can have through our In-Country Caretaker Service program:

l You can avail yourself of our Speed-to-Market Product Registration and Reimbursement
Pricing services, which is a turnkey service to meet with the two crucial elements of your
device introduction to Korea;

l You can avoid any risk of disruption in product supply in case you have new distributors in
Korea. In other words, you won’t need to repeat costly and time-consuming re-approval process
for import licenses or reimbursement pricing in case you have new distributors in Korea;

l You can directly manage your product approval and reimbursement listing in Korea at very
reasonable costs yet to the same extent of the one you can expect from your direct operation.



Pre-market product approval of medical devices in Korea are given only to locally-based firms, either local manufacturer or importer. Regulations also require a product once registered by a local party to be re-registered in order for the same product to be imported by other local firms. In other words, when you have a new distributor for a product that was being imported in to Korea, your new counterpart must re-register the same product, which could take from several months up to 1-2 years.

In order to assist foreign device suppliers in avoiding such potential risk of supply interruption in case of changing local distributors, Synex hosts its proprietary in-country caretaker services. Under your third party representative capacity, we obtain and hold products licenses and reimbursement approvals locally. We then follow your instructions regarding who should be allowed to refer to your product approvals for imports.

By subscribing with our service, you can be more flexible in partnering with local distributors. Plus, you can have your direct control over products licenses and reimbursement pricing in Korea to the same extent to the one you can expect from your expensive local operation!



Instead of offering pre-packaged services, Synex tailors the scope of work to achieve your specific objectives in the Korean market. Our service package typically starts with the two basic elements of pre-market approvals and reimbursement applications with other services to be further expanded depending on your specific needs.

Below are some examples of key components of our services available:

Our services are offered to address the two basic requirements for a device product must undergo with Korean authorities before it can be offered for sale in Korea, that is, (1) Pre-market regulatory approvals; and (2) Reimbursement coverage decision. (1) Pre-market Approval: Synex hosts product approval applications to Korean Food & Drug Administration (KFDA) and holds product licenses. Upon your decision, we will arrange your authorized local distributor to import your products into Korea based on product approvals you are holding on your behalf. (2) Reimbursement Coverage Decision: Synex locally hosts procedures and paperwork necessary to reimbursement coverage decisions by Korean reimbursement authorities. (3) Post-market Follow-ups and government correspondences for, e.g., Vigilance Reporting: As needed On-going Regulatory Communications with KFDA: As demanded Reimbursement Pricing Re-evaluation: As demanded Synex remains flexible in discussing with you in order to achieve your business objectives in Korea in the most efficient manner. Among additional areas of our particular interest are government relations and policy advocacy, local distributor search, market research and clinical trials.

Device distributors in Korea are mostly small and medium size businesses and do not expertise in regulatory or reimbursement or government relations. By utilizing our knowledge and experiences, you will have speedier access to the lucrative Korean market at strategically arranged reimbursement settings.

For more information, please contact Synex