HOW TO IMPORT MEDICAL GOODS INTO VIETNAM?

Medical equipment and pharmaceuticals are special commodities, directly related to the health and life of everyone. The State currently has strict regulations on drug import activities. However, many organizations and individuals currently do not understand the medical import process, leading to unnecessary losses. In this article, Doanh Tri Law Firm will shed light on how to import medical goods into Vietnam.

I. Legal basis

- Commercial Law 2005;

- Law on Pharmacy 2016;

- Circular 30/2015/TT-BYT ON import of medical equipment;

- Decree No. 69/2018/ND-CP on guidelines for the law on foreign trade management.

II. General Provisions

1. What is ‘medical equipment import’?

First, it is important to understand governmental regulations of medical goods in Vietnam, as the health sector is heavily regulated under the authority of the Ministry of Health (MOH). Under the MOH, the Department of Medical Equipment and Health Works (DMEHW) has jurisdiction over the import of medical devices. The Drug Administration of Vietnam (DAV) and Vietnam Food Administration (VFA) regulate pharmaceuticals and food supplements.

Theoretically, import is understood as an international trading business. It is the exchange of goods between countries in the world with the principle of parity exchange for currency as a broker and usually for a certain period. Importing is not a single act of trade, but a system of trade relations in an economy with both internal and external organizations.

Pursuant to Article 28 of Commercial Law 2005: Import of goods means that goods are brought into the Vietnamese territory from abroad or from a special area located in the territory of Vietnam, which is considered a customs area. separately in accordance with the law.

Therefore, medical equipment import means the introduction of medical equipment into the Vietnamese territory from abroad or from a special area located in the Vietnamese territory which is considered a separate customs area according to the provisions of law.

2. Medical equipment

Imported medical equipment has low import duties and no quota restrictions due to the encouraged importation of medical equipment by the government. However, medical devices are subject to regulation and licensing requirements set by the Ministry of Health.

3. Drugs

Currently, Vietnam stipulates 10 lists of imported and exported drugs with commodity codes identified as follows:

- List of toxic drugs and toxic ingredients for export and import drugs;

- The list of import-export drug ingredients that are narcotic active ingredients;

- List of raw materials for making import and export drugs that are psychotropic active ingredients;

- The list of import-export drug materials that are precursors used to make drugs;

- The list of imported and exported drugs and pharmaceutical substances on the list of substances banned from use in a number of industries and fields;

- The list of import-export drug materials that are radioactive substances used in the medical industry;

- List of import-export medicinal ingredients that are pharmaceutical ingredients and semi-finished medicinal products;

- The list of drugs contains only 1 ingredient of imported and exported pharmaceutical ingredients;

- List of drugs in the form of import-export combination;

- The list of import and export cosmetics;

According to Article 2 of the Law on Pharmacy 2016, drugs are understood as: “Drug is a preparation containing pharmaceutical substances or medicinal herbs for use in humans for the purposes of disease prevention, diagnosis, treatment, treatment, disease relief, adjustment of physiological functions of the human body, including chemical drugs pharmaceuticals, herbal medicines, traditional medicines, vaccines and biological products.”

4. Conditions for importing drugs:

Regarding the pharmacy practice certificate, the person granted the pharmacy practice certificate must have a professional diploma or certificate suitable to the requirements of the drug exporting or importing enterprise, specifically:

- A person who is granted a pharmacy practice certificate by an exporter or importer who meets the following conditions is considered a professional pharmacy manager of a drug importer: Drug manufacturing enterprises and drug wholesalers having a License having a certificate of eligibility for drug business and having a drugstore meeting the standards of Good Storage Practices, being allowed to import drugs in accordance with the pharmacy law, the regulations of the Ministry of Health and relevant laws involved.

- A person who is granted a pharmacy practice certificate by a drug-trading establishment is considered a professional pharmacy manager of a drug-exporting establishment.

- Facilities, techniques, and qualified personnel necessary for each form of drug business;

- The pharmacy manager has been granted a pharmacy practice certificate suitable to the business form.

- Facilities, techniques, and qualified personnel necessary for each form of drug business;

- The pharmacy manager has been granted a pharmacy practice certificate suitable to the business form.

- Drug manufacturers and wholesalers that have a Certificate of eligibility for drug business and have a drug warehouse meeting the standards on Good Preservation Practices are allowed to import drugs in accordance with the pharmaceutical law.

III. Procedures for import medical goods into Vietnam

1. How to obtain an import permit?

Step 1: Check for banned products

If the product is not listed under prohibited imports and exports under Decree No. 69/2018/ND-CP, it can be imported into Vietnam.

Step 2: Check for products that require a Medical Equipment Import Permit.

If the product is under the list of Appendix 1- Circular 30/2015/TT-BYT,  It needs to attain a medical equipment import Permit. If not, it can be imported following normal importation regulations.

Step 3: Apply for Import Permit

A dossier for the new issue of Medical Equipment Import Permit includes:

- Written request for issuance of the permit

- Certificate of free sale

- ISO certification

- Letter of authorization

- Catalogue describing the functions and technical parameters

- Clinical assessment material or manual of the manufacturer

- Report on the result of equipment

The dossier will be addressed to the Ministry of Health (Department of Medical Equipment and Health Facilities) and they will review the completeness and validity of the dossier within 05 working days. In case the dossier is complete and valid, a meeting of its consultation Council for issuance of medical equipment import permit will be held to review. The import permit will only be issued if there is no more requirement for modification or addition from the Council.

Step 4: Attaining other licenses:

If you are planning on distributing or selling healthcare equipment in Vietnam, you will most likely need to register your medical products by securing licenses such as Marketing authorization before any devices can enter the market.

2. How to distribute medical goods in Vietnam

Under the Law of Vietnam, only businesses registered in Vietnam with an import license will be able to distribute medical devices legally in Vietnam. Therefore, foreign medical device suppliers are required to set up a local office or appoint local distributors. Most often, foreign medical device suppliers opt for selling their medical devices through local distributors.

For foreign medical device providers and distributors, their local offices should be responsible for medical equipment licenses application. If foreign companies do not hold representative offices in Vietnam, it is possible for them to appoint a distributor or a partner company.

The above information is about the ‘How to import medical goods into Vietnam?' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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