We turn regulatory uncertainty into an executable plan, so medical devices can reach patients in Korea.
We do not stop at explaining the rules. We help products obtain approval and stay compliant on the market.
ABOUT BCG
A regulatory consulting partner that understands Korea
BCG (Biologics Consulting Group) is a regulatory consulting firm that helps overseas medical-device manufacturers and Korean importers enter the Korean market, with a focus on MFDS approval and KGMP.
To be the first regulatory partner medical-device companies call when they prepare for Korea.
We communicate clearly in three languages so overseas manufacturers and Korean importers work from the same plan.
OUR FOCUS
Our focus
BCG combines deep Korean regulatory knowledge with practical execution. We clarify the pathway, prepare the evidence and support each stage of market entry and ongoing compliance.
Medical devices & IVDs
From initial classification and documentation through KGMP, registration and post-approval maintenance, we support the connected decisions that make Korean market entry possible.
Overseas manufacturers
We translate Korean requirements into an actionable entry strategy and help coordinate with local partners.
Korean importers
We support the full regulatory flow from product onboarding and licensing to KGMP and lifecycle maintenance.
Trusted partnerships
Approved client organizations are presented here as they become available.
Client logo · awaiting approval
Client logo · awaiting approval
Client logo · awaiting approval
Client logo · awaiting approval
Client logo · awaiting approval
Client logo · awaiting approval
HISTORY
Our history
- 2022
BCG founded
- 2023
Incorporated as a company
- 2024
IVD importer licence obtained
- 2025
Medical-device importer licence obtained
- 2026
Korean · English · Chinese website launched
2022Founded
2Importer licences (medical devices · IVDs)
6Services from classification to post-approval
3languagesKorean · English · Chinese consultations
HOW WE WORK
How we work
- 1
Clear assessment
We identify applicable requirements and material risks before work begins.
- 2
Executable plans
We connect regulatory requirements with an achievable sequence of work.
- 3
Consistent collaboration
We stay aligned from the first discussion through post-approval activities.
BEFORE YOU CONTACT USBefore you contact us,
Before you contact us,
please prepare these.
You do not need everything. Attach what you have and we will start the review.
- Product name and intended use
- Country of manufacture and manufacturing site
- Overseas approval status
- Available technical, test and quality documents
Directions
Please confirm your appointment before visiting.
130, 1F, 43 Changeop-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do, Korea