Sanitary Products Import Business Report

Procedure

Procedure

1. 01

   Check whether the product is a sanitary product: Confirm that the goods fall under Article 2 of the Sanitary Products Control Act (detergents and rinse aids, oral care products, disposable cups and straws, toilet paper and paper napkins, wet wipes for food service establishments, disposable diapers and cotton swabs, etc.). Products classified as cosmetics or quasi-drugs follow procedures under other laws, so classify them first by ingredients and intended use.

2. 02

   Prepare the office and storage warehouse: Under Annex 1 of the Enforcement Rule, an independent office for business activities is required, and for e-commerce or mail-order businesses a building used as a residence may serve as the office. The warehouse may be located elsewhere or leased, and must be separated or partitioned from areas storing non-sanitary products. Where no warehouse is needed, such as selling directly from a bonded warehouse to other business operators, a separate warehouse may be omitted.

3. 03

   Complete hygiene training before filing: Take the training at an institution designated by the Minister of Food and Drug Safety and obtain a certificate of completion. If training cannot be taken in advance due to natural disaster, illness, overseas business travel or similar reasons, it must be completed within 6 months after starting business, and annual training is required after filing.

4. 04

   Submit the business report: File the Sanitary Products Import Business Report (Enforcement Rule of the Sanitary Products Control Act, Form No. 2) with the hygiene training certificate and the warehouse lease (if leased) to the competent Regional Office of Food and Drug Safety. Officials check the land use plan and building register through shared administrative information, so confirm in advance that the building records for the office and warehouse match the contracts.

5. 05

   Receive notice and the business report certificate: The authority notifies acceptance or the reason for delay within 3 days of receipt and, once accepted, issues a business report certificate (Form No. 3). If the operator's name, trade name, location or floor area later changes, file a change report using Form No. 6.

6. 06

   File an import declaration and pass inspection for each shipment: Separately from the business report, each shipment requires an import declaration (Form No. 13) with packaging or documents showing the Korean labeling, filed with the Regional Office of Food and Drug Safety with jurisdiction over the place of entry. It may be filed from 5 days before the expected arrival date, and an import declaration confirmation is issued if the inspection result is compliant. If notified of non-compliance, the goods must be returned, destroyed or converted to another use within 1 year.

Filing route

Filing route

Deadlines & processing notes

Deadlines & processing notes

Basic documents

Basic documents

Operating without a business report or importing sanitary products without the per-shipment import declaration is punishable by imprisonment of up to 1 year or a fine of up to 10 million won, and failing to complete hygiene training carries an administrative fine of up to 1 million won.