Medical Industry: Key procedures to start trading Medical Equipment in Vietnam

Vietnam’s medical equipment market is growing rapidly, attracting foreign investors and enterprises. This upward trend was evident during the Vietnam Medipharm Expo 2024, which hosted its 22nd Exhibition in Ho Chi Minh City and 30th in Hanoi, gathering hundreds of enterprises from diverse countries and territories, including India, South Korea, and China, providing an opportunity for domestic and foreign investors to connect and expand business opportunities in Vietnam[1]. In his opening speech at the Exhibition in Ho Chi Minh City, the Director of the Drug Administration of Vietnam – Mr. Vu Tuan Cuong highlighted that the medical equipment sector is drawing significant foreign investment[2].

Overview of the Medical Market in Vietnam

Vietnam’s medical equipment market, valued at USD 1.67 billion and ranking 8th in the Asia-Pacific region[3]. With nearly 1,500 public hospitals, more than 300 private hospitals, and nearly 70,000 private clinics, the healthcare system is expanding to meet rising demand[4]. Under the Master Plan for the Network of Healthcare Facilities (period 2021–2030, vision to 2050), upgrading hospital infrastructure and equipment is a priority investment projects[5], signaling promising opportunities for investors in this dynamic market.

How Foreign Investors Can Start Trading Medical Equipment in Vietnam

To officially enter Vietnam’s medical equipment market, key procedures for foreign investors are Establishing a company, and Fulfilling other required conditions and relevant sublicenses to legally operate in the business. 

1) Company Establishment

Foreign investors typically establish a trading company (“Company”) in the Limited Liability Company form – an independent entity with full control and limited liability within the scope of the contributed capital, to engage in selling and import medical equipment in the country, by two key steps:

Step 1. Obtaining the Investment Registration Certificate (IRC)

Step 2.  Obtaining the Enterprise Registration Certificate (ERC)

The Company shall register specific business lines[6] to include all the activities that the Company will perform, such as:

  • 4649 – Wholesale of other household products;
  • 4659 – Wholesale of other machinery and equipment;
  • 4669 – Other specialized wholesale not elsewhere classified;
  • 4772 – Retail sale of pharmaceuticals, medical equipment, cosmetics, and sanitary items in specialized stores;
  • 8299 – Other remaining business support service activities not elsewhere classified.

Notably, the Company’s charter capital must be fully contributed within 90 (ninety) days of the ERC’s issuance.

2) Fulfilling other required procedures

Medical equipment trading is a conditional business line[7]; therefore, the Company must meet the required conditions and obtain the necessary sublicense to operate in this field and ensure the products are legally circulated in Vietnam through the following procedures:

SubjectProcedureDetail
The CompanyDeclaration of eligibility for medical equipment trading (Công bố đủ điều kiện mua bán thiết bị y tế)[8]The Company shall submit a dossier to the Department of Health (DoH), which will publicly publish the declaration information and the dossier if the following conditions are met: Personnel (at least one technical staff member with a college degree or higher in a relevant technical or medical field);Storage Facilities (adequate size, well-ventilated, dry, clean, away from contamination sources, and compliant with product-specific guidelines);Transportation Means (suitable for the product type or backed by a contract with a qualified entity).   *The procedure is not required for specific products like personal blood pressure monitors, baby nasal aspirators, electronic thermometers, etc.[9]
Obtaining Retail License (Giấy phép bán lẻ) or Retail Establishment License (Giấy phép lập cơ sở bán lẻ)[10]   *only in the case of retailingThe Company shall submit dossiers to the Department of Industry and Trade to obtain the Retail License to distribute retail and the Retail Establishment Licenseto set up a retail outlet, if: Meeting market access conditions;Having a financial plan to support retail activities;Having no overdue tax debts, if operating in Vietnam for over one year.
Medical EquipmentDeclaration of Applied Standards (Công bố tiêu chuẩn áp dụng) or Circulation Registration (Đăng ký lưu hành)[11]Medical equipment shall be classified by the Company into Class A, B, C, or D, in ascending order, based on the level of potential risk[12]. The Company then submits a dossier to the DoH for Declaration of Applied Standards for Class A and Class B, or to the MoH for Circulation Registration for Class C and Class D to obtain a circulation number for legal distribution.   The products shall meet the following conditions[13]: Domestic products: Manufactured at a certified facility meeting production conditions;Foreign products: Manufactured at an ISO 13485-certified facility and approved for circulation globally for imported medical equipment;Compliant with national technical regulations or declared manufacturer standards.    

Conclusion

Vietnam’s medical equipment market is highly attractive, offering significant opportunities for investors. However, to operate legally, enterprises must adhere to strict regulations to ensure compliance with legal and operational standards. Proper adherence ensures lawful and successful entry into this promising market.

In D’Andrea & Partners Legal Counsel we have authored innovative publications exploring Vietnam, produced in order to provide foreign investors and businesses with more practical guidance on how to do business in Vietnam, as it requires a specific context of the economic and legal framework of the country, including tailor-made consultancy for trading medical equipment in Vietnam.

The above content is provided for informational purposes only. The provision of this article does not create an attorney-client relationship between D’Andrea & Partners and the reader and does not constitute legal advice. Legal advice must be tailored to the specific circumstances of each case, and the contents of this article are not a substitute for legal counsel.


[1] Source: https://hn.medipharmexpo.com/en/

[2] Source: https://vinexad.com.vn/khai-mac-trien-lam-quoc-te-chuyen-nganh-y-duoc-nam-2024/

[3] Source: https://baotintuc.vn/kinh-te/thi-truong-thiet-bi-y-te-viet-nam-thu-hut-nhieu-nha-dau-tu-nuoc-ngoai-20240801155034120.htm

[4] Statistics from the Ministry of Health presented at the Digital Transformation Activities Review Conference on 10th April 2024

Source: https://vnexpress.net/ca-nuoc-chi-70-benh-vien-dung-benh-an-dien-tu-4732748.html

[5] Decision 201/QD-TTg

[6] Decision 27/2018/QD-TTg

[7] Appendix IV of Law on Investment 2020

[8] Article 40 and 41 of Decree 98/2021/ND-CP

[9] Article 42 of Decree 98/2021/ND-CP and Article 4 of Circular 05/2022/TT-BYT

[10] Article 5, 8, 9, 12, and 13 of Decree 09/2018/ND-CP

[11] Article 26 to Article 32 of Decree 98/2021/ND-CP

[12] Article 4 and 5 of Decree 98/2021/ND-CP

[13] Article 23.1 of Decree 98/2021/ND-CP

Carlo Fabrizi Carlo Fabrizi

Carlo Fabrizi

Legal Advisor
Carlo Fabrizi, a representative of D’Andrea & Partners Legal Counsel, handles Foreign Direct Investment projects in Vietnam and South China
Riccardo Verzella Riccardo Verzella

Riccardo Verzella

Senior Associate
Riccardo Verzella, a highly qualified Italian lawyer, has been based in Shanghai, China since January 2020.

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