BCG Services.
We support medical device and IVD companies
in addressing complex regulatory challenges.
Our consultants bring practical experience from Korean and international companies.
Our experience across diverse products and specialist disciplines helps us address complex challenges.
Manufacturing & Import Business Licences
We support the procedures required to meet regulatory requirements and obtain medical device manufacturing and import business licences in Korea.
KGMP Certification
We assess manufacturing processes and quality systems against Korean medical device GMP requirements and provide tailored support for KGMP certification.
Medical Device Registration
We support registration procedures for Class 1–4 medical devices and IVDs in Korea.
Registration Renewal
We support periodic registration renewal to maintain regulatory compliance for devices already placed on the Korean market.
Reimbursement Listing
We support reimbursement listing for medical supplies through market analysis, economic evaluation, application preparation and responses to review questions.
Local Regulatory Representation
We provide local regulatory representation for overseas medical device manufacturers entering the Korean market.
GxP Translation & Interpreting
We provide specialist translation and interpreting for medical device and pharmaceutical regulatory affairs.