Global RA Consultancy Network

Connect with our trusted network of regulatory affairs consultancies specializing in medical device registration and compliance across major global markets.

Disclaimer

The information provided about consultancies is for reference purposes only. ElendiLabs does not guarantee the accuracy, completeness, or currency of the information. Users are advised to verify all details directly with the respective consultancy before engaging their services. ElendiLabs is not responsible for the services, advice, or actions of any listed consultancy.

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MDREX, Medical Device, Digital Health Consulting Group

Seoul, Republic of Korea (HQ), Japan Office

Registration

Distribution

Marketing

We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.

Specializations

MFDS Product Approval (Korea)

KGMP Certification (Quality System)

HIRA Reimbursement Strategy & Listing

Clinical Consulting & Trial Planning

SaMD (Software as a Medical Device) Regulatory

Import Device Approval Certificate Holding (ICC)

Regulatory Compliance Check & Defense

Languages: Korean, English, Japanese

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