In Vietnam, the distribution and advertising of medical devices are subject to specific rules and regulations. Understanding these guidelines is essential for manufacturers and distributors to ensure compliance and navigate the market effectively. In this article, we will provide an overview of the distribution rules and advertising regulations for medical devices in Vietnam, shedding light on the key considerations and requirements that businesses need to be aware of. By grasping the intricacies of these regulations, companies can successfully navigate the Vietnamese market and contribute to the safe and effective use of medical devices in the country.
Introduction
In our newsletter dated July 5, 2023, we discussed the classification of Software as a Medical Device (SaMD) in Vietnam and its status within the medical device framework. It was highlighted that SaMD will be regulated as a medical device in Vietnam if it fulfills the necessary requirements. In this newsletter, we will provide a brief introduction to two topics: the licensing requirements for importing and selling medical devices from overseas in Vietnam, and an overview of the regulations governing advertising for the sale of medical devices within the country.
Overview of required license/certificate for corporations/individuals to distribute medical devices from outside Vietnam
Parties involved in distribution
The importation and sale of medical devices in Vietnam from outside the country involves the following parties:
+ Importers: These are organizations or individuals responsible for exporting and importing medical devices.
+ Traders: These are organizations or individuals engaged in the buying and selling of medical devices.
In practice, the Importer and Trader may be the same entity or separate entities. However, the licenses required for each entity will vary depending on the specific characteristics of the medical device in question and the activities undertaken by the relevant parties. These activities encompass export, import, trading arrangements, and corporate structure. Therefore, it’s crucial to understand the regulatory landscape comprehensively to ensure compliance and streamline operations in the medical device industry.
Importer
To import and deal with medical devices in Vietnam, it is essential for importers to meet certain requirements. This includes either being registered as an “Authorized Entity” or being authorized by an existing “Authorized Entity” in Vietnam. There are two ways to fulfill this prerequisite:
Registration as an Authorized Entity: Under Article 25.1 of Decree 98/2021/ND-CP, the Authorized Entity can be one of the following:
a) Vietnamese enterprises, cooperatives, or household businesses that own the medical devices.
b) Vietnamese enterprises, cooperatives, or household businesses that have been authorized by the owner of the medical devices.
c) Representative offices in Vietnam of foreign traders who own the medical devices or have been authorized by the owner.
The establishment of these entities requires specific licenses:
+ Vietnamese enterprises need an Enterprise Registration Certificate in accordance with Article 27 of the Law on Enterprise and an Investment Registration Certificate as per Article 37.1 of the Law on Investment (if applicable).
+ Cooperatives require a Cooperatives Registration Certificate under Article 24 of the Law on Cooperatives.
+ Household businesses must obtain a Household Businesses Registration Certificate following Article 82 of Decree 01/2021/ND-CP.
+ Representative offices of foreign traders in Vietnam need a Representative Office Establishment Certificate based on Article 7 of Decree 07/2016/ND-CP.
Authorization by an Authorized Entity: Importers must possess certificates proving their establishment, such as an Enterprise Registration Certificate and an Investment Registration Certificate (if applicable). Additionally, they must obtain written authorization from the Authorized Entity to import medical devices into Vietnam.
Trader
As a trader, you will need the following essential licenses/certificates:
+ Certificate(s) for your establishment, such as an Enterprise Registration Certificate and an Investment Registration Certificate (if applicable).
+ A declaration of eligibility for medical device trading, which is issued by the Department of Health. This declaration is required before trading medical devices classified under Class-B, Class-C, or Class-D, except for those medical devices listed by the Minister of Health as eligible to be sold like regular goods (Article 41 of Decree 98).
+ If you are a “foreign-invested entity” engaged in retail trading of medical devices, you will also need a trading license for the retail distribution of goods. This license is obtained under Article 5.1(a) of Decree 09/2018/ND-CP. A “foreign-invested entity” refers to an entity in which:
a) One or more of its shareholders/owners is a foreign investor (FDI 1),
b) More than 50% of its charter capital is held by another entity (“Tier 1 Co.”), and this Tier 1 has more than 50% of its charter capital held by a foreign investor (FDI 2),
c) More than 50% of its charter capital is held by foreign investors and a Tier 1 (FDI 3).
Conclusion
In conclusion, the distribution rules and advertising regulations surrounding medical devices in Vietnam play a crucial role in ensuring the safety, quality, and efficacy of these products. Also with a strict requirements for importers, traders, and authorized entities help maintain a transparent and accountable system. Consequently, by adhering to these regulations, the Vietnamese healthcare sector can confidently provide its population with safe and effective medical devices.
Furthermore, all stakeholders involved in the distribution and advertising of devices must stay updated with the latest guidelines.
They must comply with the regulatory framework to ensure the well-being of the public and promote a thriving healthcare industry in Vietnam.
HMLF is always available to offer assistance in understanding the procedures with authorities.
Harley Miller Law Firm “HMLF”
Head office: 14th floor, HM Town building, 412 Nguyen Thi Minh Khai, Ward 05, District 3, Ho Chi Minh City.
Phone number: +84 937215585
Website: hmlf.vn Email: miller@hmlf.vn