Certification and Licensing

Medical device licensing

Selection of technologically innovative small and medium-sized enterprises

1. What is a medical device?

Medical device certificationIt is a device, machine, or apparatus used for people or animals.
This is a system in which government agencies (such as the Ministry of Food and Drug Safety) review products for safety and efficacy and grant permission to manufacture, import, and sell them.
Distributing products without a license is the most crucial gateway to the medical device business, as it can lead to legal sanctions and even the revocation of business licenses.

2. Practical overview and requirements

1. Legal basis and requirements

The medical device industry is directly related to human life, so it is strictly Legal basisIt operates according to .

Legal basis: Medical Device Act, Enforcement Decree and Enforcement Rules of the Medical Device Act
Key requirements:
- Facility Requirements: Securing suitable manufacturing/import facilities and quality management systems (GMP)
- Human Resources: Designation of a quality control manager (compliance with qualification requirements)
- Technical Requirements: Obtaining proof of the product's physical, chemical, and biological safety and performance

2. Key Documents to Prepare

Medical Device Manufacturing (Import) Permit/Certification/Report Application Form
Technical Documentation: Principle of operation, shape and structure, raw materials, performance, test specifications, etc.
Test Report: Data issued by a testing institute designated by the Ministry of Food and Drug Safety
GMP Compliance Certificate: Certificate of Compliance with Manufacturing and Quality Control Standards
Clinical trial data: (Limited to products of grades 3 and 4 and new technology)

3. Expected duration

Grade 1: About 1 month (when reporting)
Grade 2: Approximately 2 to 4 months (including testing and certification review)
Grade 3/4: Approximately 6 months to 1 year or more (including clinical and technical documentation review)

3. Medical device classification (type)

division	For the sake of	Management style	Review agency
1st grade	Little potential harm	declaration	Medical Device Information Technology Support Center
2nd grade	Low potential hazard	certification	Korea Medical Device Safety Information Institute (designated organization)
3rd grade	Moderate hazard	permission	Ministry of Food and Drug Safety Headquarters
Grade 4	High risk (high hazard)	permission	Ministry of Food and Drug Safety Headquarters

Medical Device Procedures

1

Product Definition and Rating Review
Check classification number and compare essential equivalence
2

Preparation for industry approval and GMP
Recognition of conformity with manufacturing/import business license and quality control standards
3

Performing tests and inspections
Physical, electrical, and biological testing for technical documentation
4

Clinical trials (if necessary)
Performed in cases where it is different from existing products, such as newly developed medical devices
5

Complaint reception
Submitting documents through the medical device electronic civil complaint system
6

Review and supplement
Review and supplementation of technical documents by the Ministry of Food and Drug Safety/certification agency
7

Issuance of permit
Issuance of final product permit/certificate and marketing

Why You Need a Trusted Administrative Scrivener

Medical device approval is not just about filling out paperwork; it's about regulatory science.

1. Strategic Approach

Reduce trial and error by designing the optimal approval path (e.g. utilizing equivalence) for each product item.
2. Legal representation

In accordance with the Administrative Litigation Act
This is a nationally licensed professional who can officially represent you in permit applications and administrative agency responses.
3. Cost and time savings

Eliminate unnecessary testing items and respond promptly to supplementation requests to accelerate product launch.
4. Risk Management

We proactively prevent business disruption risks by establishing a GMP system and supporting post-management.

The barriers to entry into the medical device market are higher and more complex than you might think.
Even with innovative ideas and technological capabilities,
Blocked by complex administrative procedures and regulatory walls
I feel sad whenever I see companies that don't see the light of day.

Licensing is not simply the process of obtaining a 'license'.,
Your valuable technology
A foundation for safely recognizing value in the marketno see.
From the first step of classification to the rigorous technical document review, we will be your reliable partner.
We will show you the fastest and most accurate way.
Seum will be with you until your innovation takes hold in the market.

December 29, 2025
Seum Administrative Attorney Firm
Written by: Sangyoon Kim, Administrative Scrivener

Frequently Asked Questions (FAQ)

Q: How do I verify that my product is a medical device?

A: If the purpose of use is to diagnose, treat, alleviate, or modify the structure or function of a disease, it is likely to be a medical device.
You should first check the classification number with an expert.
However, if verification is difficult, please check through the National Petition Center inquiry.