Product Registration

In Vietnam, regulated industries and goods are monitored by the country’s equivalent to the Food and Drug Adminitration (FDA). The Vietnamese authorities are divided based on specific areas of activity:

• Vietnam Food Safety Authority (VFA): Oversees quality control and regulatory standards for food and beverage products intended for Vietnamese consumers.

• Drug Administration of Vietnam (DAV): Monitors production and distribution of pharmaceutical products and cosmetics.

• Ministry of Health (MOH): Handles healthcare and related operations issues, such as medical device registration and imports.

These regulatory bodies aim to protect public interests and prevent hazardous or inefficient products from entering the Vietnamese consumer market by requiring product registration.

I. Required documents for product registration in Vietnam

1. Food and beverage:

• Business Registration Certificate

• Detailed product information

• Samples of complete products

• Product label

• Information and scientific data proving the effectiveness and function of each constitutional component

• Specification sheet from the manufacturer

• Certificate of Analysis

• Certificate of Free Sale, Exportation, or Health (Imports)

• Certificate of Good Manufacturing Practice (GMP)

2. Cosmetic products:

• Notification Dossier (Imports):

— Notification form

— Power of Attorney from Manufacturer

— Certificate of Free Sale

• Administrative information (Product name, intended use, details of manufacturer)

• Product quality data Product safety assessment reports

• Samples of product label

• List of ingredients and product formula

• Safety Data Sheet Clinical test reports

• Information on quality control

II. Product registration process in Vietnam

The product registration process will vary depending on the specific product being registered. The timeline is variable but can take up to three months.

Lexica LLC assists you in securing the necessary documents to ensure that the application is complete and meets all requirements. Our advisors will also submit and manage the process for you:

1. Application review by our advisors and submission to the relevant regulatory authority based on your product;

2. Supplementation of application on request (receiving authority can request the applicant to supplement the application only once);

3. Receiving authority posts supplier names and product details on its website and updates relevant databases.