KFDA Procedures for Cosmetics,

Food, Health Supplements,

Pharmaceuticals,

and Medical Devices

Introduction

The Korea Food and Drug Administration (KFDA), now known as the Ministry of Food and Drug Safety (MFDS), oversees the approval and regulation of cosmetics, food, health supplements, pharmaceuticals, and medical devices in South Korea. This document provides a step-by-step guide to the registration and approval procedures for these categories.

1. Procedures for Cosmetics

1.1 Product Classification: Identify the product type (general cosmetics or functional cosmetics) to determine the registration requirements.

1.2 Document Preparation: Prepare necessary documents, including product formula, safety test reports, and labeling details.

1.3 Application Submission: Submit the application through the MFDS online portal.

1.4 Approval: General cosmetics require notification, while functional cosmetics require approval. Once approved, the product can be marketed.

2. Procedures for Food

2.1 Product Classification: Determine if the product is a general food item or requires special regulatory approval.

2.2 Document Preparation: Include safety test reports, ingredient list, manufacturing process, and certificates of origin.

2.3 Application Submission: Submit the application via the MFDS online system.

2.4 Approval: MFDS reviews the application and issues a certification for compliant products.

3. Procedures for Health Supplements

3.1 Product Classification: Identify if the product falls under health functional foods or general health supplements.

3.2 Document Preparation: Include safety and efficacy data, GMP certification, and ingredient details.

3.3 Application Submission: Applications are submitted through the MFDS system along with applicable fees.

3.4 Approval: Approval is granted after thorough evaluation of safety, efficacy, and labeling compliance.

4. Procedures for Pharmaceuticals

4.1 Product Classification: Determine if the product is an over-the-counter drug or prescription medicine.

4.2 Document Preparation: Submit clinical trial data, manufacturing details, stability reports, and GMP certificates.

4.3 Application Submission: Applications are filed via the MFDS online system.

4.4 Approval: MFDS evaluates safety, efficacy, and manufacturing practices before granting approval.

5. Procedures for Medical Devices

5.1 Product Classification: Classify the medical device into one of four risk categories (Class I to IV).

5.2 Document Preparation: Include device specifications, clinical trial data (if applicable), and quality certifications.

5.3 Application Submission: Submit the application through the MFDS platform with supporting documentation.

5.4 Approval: Approval is granted after safety and efficacy evaluation, along with compliance with technical standards.

6. Compliance and Post-Approval Requirements

Manufacturers and distributors must adhere to ongoing MFDS regulations, including periodic audits and reporting. Non-compliance can result in penalties, product recalls, or license revocation.

7. Timeframes and Fees

The duration for registration varies depending on the product type, ranging from 1 to 12 months. Fees are determined based on the product category and complexity of evaluation.