South Korea medical device registration

KFDA (MFDS) registration Are you a CEO looking to expand your business in Korea ? Are you a

KFDA (MFDS) registration

Are you a CEO looking to expand your business in Korea ?

Are you a regulatory affair manager and the marketing/sales team has identified a potential market in Korea ?

Are you the marketing/sales manager of the Asian zone and you want to explore the possible strategies to enter the Korean market ?

Are you having difficulties to manage both regulatory and commercial aspects with your distributor and you want to split them ?

We are here to help you find solutions. South Korea has one of the most highly regulated market in the world for medical devices, you will need help !

Regulatory process: South Korea medical device registration

We prepared a guide in order to explain this process. This guide will be useful for regulatory professionals, it contains detailed information on how the Ministry of Food and Drug Safety (previously KFDA as Korean Food and Drug Administration) regulate the medical devices in Korea.

You can find it here: Korean Medical Devices Regulations.

Execution strategy

Our execution strategy incorporates proven methodologies, extremely qualified personnel, and a highly responsive approach to managing deliverables. Following is a description of our project methods, including how the project will be developed, a proposed time line of events.

How Kobridge helps for the South Korean market:

  • Technical document preparation before review by MFDS or 3rd Party
  • South Korea MFDS mock inspection service
  • Medical device distributor search and evaluation in Korea
  • License holder
  • South Korea MFDS Medical device registration and approval
  • Korean KGMP quality management compliance

Korean GMP

Technical/Project Approach

Here is how we will work together:

  1. Preliminary analysis (product information in form of brochures is required so that we can give you an estimate)
    1. Determine the class of the product (category, systems, if any)
    2. Distinguish products that require only notification and products that require registration
    3. Check the necessity for your company to obtain Korean Good Manufacturing Practice certificate
    4. Inform you about the exact fees charged by MFDS and third parties
    5. Inform you about any additional tests required (laboratory tests, etc…)
  2. You receive an “assignment letter” to allow us to review your product documentation.
  3. You receive a Non-Disclosure agreement
  4. Based on the information collected during the preliminary analysis, we send you the detailed estimate of the complete registration process
  5. You receive the “Service Agreement”
  6. We collect documentation for : Technical Document Review (TDR), and Korean Good Manufacturing Practice (KGMP) – if required
  7. We apply for KGMP (if required) inspection
  8. We perform a pre-assessment of your readiness for KGMP
  9. We submit all documents for TDR and KGMP to the reviewers
  10. We assist you during the KGMP inspection
  11. Once registration is complete, we give you the complete file that was submitted to MFDS so that it remains your property

We keep you informed about any post-market activity after registration is complete.

 

Resources

We use the project management platform to manage our projects. That way you also have access to the same platform, you can see the progress “live”, interact with our team and have full transparency.

We consider we fail if you ask about the progress of the project so we keep you informed on a bi-weekly basis at least.

We will appoint a project manager and its assistant who will be in charge of the whole process.


 

If you wish to sell in South Korea you can contact us for a preliminary discussion.

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