Life Sciences Product Registration in South Korea

Comprehensive support for securing product approvals and regulatory compliance across all life sciences sectors in South Korea.

Services We Offer

In South Korea, the regulatory environment for life sciences products requires a thorough understanding of local laws and standards. Artixio offers expert support in securing product approvals, handling complex documentation, and ensuring compliance across all industries, from pharmaceuticals to medical devices.

We handle all aspects of product registration, from initial classification and documentation to submission and post-market compliance. Our local knowledge and international experience help reduce delays and improve approval chances, making us a trusted partner in South Korea’s regulatory space.

Regulatory Bodies We Work With

Regulatory Body	Industry
Ministry of Food and Drug Safety (MFDS)	Pharmaceuticals, Medical Devices, Biologics, Cosmetics
Korea Food and Drug Administration (KFDA)	Pharmaceuticals, Biologics
Korea Institute of Industrial Technology (KIIT)	MedTech, Medical Devices
Korea Health Industry Development Institute (KHIDI)	Pharmaceuticals, MedTech, Biologics
Animal and Plant Quarantine Agency (APQA)	Veterinary Products, Animal Health

Product Registration Lifecycle in South Korea

We manage the entire lifecycle of product registration in South Korea:

Why Partner with Artixio for Product Registration in South Korea

Expertise in South Korea's regulatory environment
In-depth knowledge of local product approval processes
End-to-end support from registration to post-market compliance
Proven track record with successful product approvals
Experienced team with 15-30+ years in the industry

FAQs

Do I need local clinical data for product approval in South Korea?

Yes, local clinical data may be required, especially for pharmaceuticals and medical devices, depending on the product’s classification.

What documentation is needed for product registration in South Korea?

Required documents include product classification, technical dossiers, clinical trial data (if applicable), labeling, and manufacturing certificates.

How do I know if my product needs approval from the Ministry of Food and Drug Safety (MFDS)?

Our team will assess your product based on its category (pharmaceuticals, medical devices, cosmetics, etc.) and determine if MFDS approval is required.

How will I be updated on the progress of my product’s registration?

We provide regular updates throughout the process and ensure you are informed at every stage, from submission to approval.