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Regulatory Compliance and Product Life Cycle Management in South Korea
Artixio Ensures Regulatory Compliance From Strategic Planning Through Product Launch and South Korean Post-Market Surveillance Across the Life Sciences Product Lifecycle.
South Korea
South Korea has emerged as the third largest pharmaceutical hub in the Asia-Pacific life sciences market, driven by rapid advancements in pharmaceuticals, biotechnology, medical devices, and digital health. South Korean market is valued at ~USD 20 billion. This growth has led to increasing demand for robust regulatory affairs services, both domestically and for international expansion.
With significant business opportunities in South Korea, regulatory consulting firms are expanding their offerings in clinical, CMC, and post-marketing compliance services; and there is a rise in freelance and remote regulatory professionals; and areas such as eCTD submissions, strategic regulatory planning, and labeling compliance are in demand.
With over a decade of industry experience, Artixio offers expert regulatory services to enable clients to launch product into the market successfully and surveillance of post market regulatory requirements.
Regulatory Authorities In South Korea
Ministry of Food and Drug Safety (MFDS) is responsible for protection of public health by ensuring the safety, efficacy, and quality of drugs, medical devices, cosmetics, and food products.
Key Authorites under MFDS and Their Roles
Pharmaceutical Safety Bureau oversees the process of Drug evaluation, approval, GMP inspections, post-market surveillance. While, the Medical Device Safety Bureau is responsible for Classification, approval, QMS compliance, and monitoring of medical devices and IVDs. Food Safety Evaluation Bureau ensures safety of general foods and manages hazard controls. Functional Food & Cosmetic Safety Bureau regulates dietary supplements, functional foods, and cosmetics.
Regulatory Compliance & Registration Process In South Korea
Pre-Registration
- Regulatory Intelligence & Strategy customised for South Korean market
- Product / Market Prioritization to Suit South Korean Market Conditions
- Dossier Gap Analysis
- Technical Due Diligence
- South Korean Market Access Strategy
Registration
- MFDS Product Registration and Korean Authorized Representative (KAR)
- Dossier Preparation as per MFDS standards
- Medical / Technical Writing Labeling and Artwork
- MFDS Review Preparation
- Health Authority Meetings and Liaison
- MFDS Audit Support
- eCTD/CTD Publishing and Submission
- Response to Queries / Approvals
- Compliance Analysis and Assessment
- QMS, Mock Audits; Vendor Audits; Regulatory Audits
- Pricing & Reimbursement
Post-Registration
- Complete Product Lifecycle Management
- Artwork / Label / Ad-promo Reviews as per MFDS guidelines
- Line Extensions of the products
- Inspection support
- Response to MFDS Regulatory / Safety Queries Distribution / Import Assistance
- MFDS Compliance monitoring
- Post-marketing Surveillance
- Product Recall & Change Management
- Advertisement & Promotional Material Review
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Artixio?
Complete product lifecycle management and maintenance
Expertise in global and local regulatory framework
Over 15-35 years of industry experience with 200+ successful product launch
ISO 9001:2015 certified company with high quality standards
Client-focused, flexible service models and solutions.
Industries We Serve in the South Korea
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
Is English accepted for regulatory submissions?
No. All regulatory dossiers, including applications, labeling, and clinical trial protocols, must be submitted in Korean. Supporting data may be in English.
Does South Korea follow ICH and global regulatory standards?
Yes. South Korea is a member of ICH, PIC/S, and IMDRF, and MFDS aligns with international guidelines for GCP, GMP, and GLP compliance.
Are clinical trials conducted in Korea accepted by other countries?
Yes. MFDS regulated trials are generally acceptable to FDA, EMA, and PMDA.
Can foreign manufacturers directly import and sell products in Korea?
No. Foreign manufacturers need to appoint a licensed Korean importer or distributor for import/export of products.
Artixio addresses these challenges by providing flexible, budget friendly and timely compliance solutions and regulatory affairs services using global standards for seamless projects delivery, secure information exchange, high quality services, regional expertise and network and systems driven processes.
Are there expedited approval pathways?
Yes. MFDS offers priority review and fast-track designations for Orphan drugs and rare diseases.
Our Global Reach: Serving Life Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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