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Comprehensive Guide to Import Procedures for Acne Patches in Vietnam (Latest Update)

Date Submitted: 3 giờ trước

Acne patches have become one of the most popular skincare and personal care products in the Vietnamese market. However, importing these products requires careful attention because they may be classified either as cosmetics or medical devices, depending on their ingredients and intended use.

Below is a detailed guide on HS codes, import duties, and import procedures to help businesses prepare the necessary documentation accurately.

1. Classification of Acne Patches

The first and most important step before importing acne patches is determining their correct classification. Generally, acne patches fall into one of the following categories:

Medical Device

Acne patches made primarily of 100% Hydrocolloid are designed to protect open acne wounds (such as popped pimples) from bacteria, absorb wound exudate, and maintain a moist healing environment. They do not contain active pharmaceutical ingredients with therapeutic effects.

Under Decree No. 98/2021/ND-CP and its implementing regulations, including Circular No. 05/2022/TT-BYT, these products are generally classified as Class A Medical Devices in Vietnam.

Cosmetic Product

Acne patches containing active ingredients such as Salicylic Acid (BHA), Tea Tree Oil, or other acne-treatment substances are primarily intended to treat acne, dry blemishes, or improve skin conditions. These products are generally classified as cosmetics, requiring a Cosmetic Product Notification before importation.

Note: This article focuses on the import procedures for Hydrocolloid Acne Patches classified as Class A Medical Devices, which is the most common scenario.

2. HS Code and Import Duties

Selecting the correct HS code is essential for calculating import taxes accurately.

Reference HS Codes:

3005.10.90
3005.90.90

These HS codes belong to the category of:

"Wadding, gauze, bandages and similar articles, impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes."

Import Duty

MFN Import Duty: Generally 0%–5%, depending on the applicable HS code.

Value Added Tax (VAT)

VAT is generally:

5% for qualified medical devices that meet the applicable regulatory requirements and supporting documentation; or
8%–10%, depending on the applicable tax regulations in effect at the time of importation and the product classification.

Preferential Import Duty under FTAs

If the products originate from countries having Free Trade Agreements (FTAs) with Vietnam—such as South Korea, China, Japan, etc.—and are accompanied by valid Certificates of Origin (e.g., Form E, Form AK, Form VJ), the products may qualify for 0% preferential import duty.

3. Import Procedures for Class A Medical Device Acne Patches

To ensure smooth customs clearance, importers should follow the steps below.

Step 1: Medical Device Classification

The product must first be classified by a qualified medical device classification organization.

For standard Hydrocolloid acne patches, the result is generally Class A Medical Device.

Step 2: Declaration of Applicable Standards for Class A Medical Devices

The importer submits the declaration dossier to the provincial Department of Health where the company is registered.

The basic dossier typically includes:

Declaration of Applicable Standards;
Medical Device Classification Result;
Manufacturer's ISO 13485 Certificate;
Letter of Authorization issued by the product owner/manufacturer;
Warranty Eligibility Certificate (if applicable);
Technical documentation;
Original product label;
Certificate of Free Sale (CFS), if available.

Step 3: Prepare Customs Documentation

After obtaining the Acknowledgment of Declaration of Applicable Standards for Class A Medical Devices, the importer may proceed with customs declaration.

The customs dossier generally includes:

Import Customs Declaration;
Commercial Invoice;
Packing List;
Bill of Lading;
Certificate of Origin (if applicable);
Medical Device Classification Result;
Acknowledgment of Declaration of Applicable Standards for Class A Medical Devices.

Step 4: Customs Clearance and Delivery

Submit the customs dossier to the Customs Authority, complete tax payment, and obtain customs clearance.

Before distributing the products in the Vietnamese market, the importer must affix Vietnamese supplementary labels in compliance with Vietnamese labeling regulations.

Songwin International Logistics Vietnam – Your One-Stop Import Solution

Handling the classification and declaration procedures for acne patches requires extensive knowledge of Vietnam's medical device regulations and practical customs procedures. Even minor documentation errors may result in customs delays, additional storage charges, and unnecessary costs.

Songwin International Logistics Vietnam provides comprehensive logistics and customs solutions to help your shipments clear customs efficiently while minimizing risks and costs.

Our services include:

Professional Regulatory Consultation

Our specialists evaluate your product ingredients and technical documentation to accurately determine whether your acne patches should be classified as cosmetics or medical devices, ensuring the most appropriate import strategy.

Regulatory Compliance Support

We assist clients in completing medical device classification and Class A declaration procedures accurately and efficiently.

Complete Customs Brokerage Services

Our experienced customs team handles all customs documentation, determines the appropriate HS code, and helps maximize tariff benefits available under Free Trade Agreements.

International Freight Services

We provide competitive international freight solutions via:

Ocean Freight (FCL & LCL)
Air Freight

covering major trade lanes from South Korea, China, Japan, the United States, and Europe to Vietnam.

With extensive experience in handling imported medical devices and cosmetic products, Songwin International Logistics Vietnam is committed to supporting your business throughout every stage of the supply chain.