Compliance Consulting Services in South Korea

Artixio Ensures MFDS Regulatory Compliance Support From Strategic Planning Through Product Launch and South Korean Post-Market Surveillance Across the Life Sciences Product Lifecycle.

South Korea

MFDS Compliance Consulting Services in 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 Authorities 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.

Compliance Support and 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

Why Artixio For MFDS Regulatory Compliance Support?

Full Regulatory Support for Market Entry into South Korea

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.

Compliance Consulting Services in South Korea

South Korea

MFDS Compliance Consulting Services in South Korea

Regulatory Authorities in South Korea

Key Authorities under MFDS and Their Roles

Compliance Support and Registration Process in South Korea

Pre-Registration

Registration

Post-Registration

Why Artixio For MFDS Regulatory Compliance Support?

Full Regulatory Support for Market Entry into South Korea

FAQs

Is English accepted for regulatory submissions?

Does South Korea follow ICH and global regulatory standards?

Are clinical trials conducted in Korea accepted by other countries?

Can foreign manufacturers directly import and sell products in Korea?

Are there expedited approval pathways?

Industries We Serve in the South Korea

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Related South Korea Services

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