Overview
Vietnam has transformed remarkably from one of the world’s poorest countries to a lower-middle-income country, with a GDP per capita of USD 4,086 in 2022. According to the International Monetary Fund (IMF) World Economic Outlook, Vietnam’s GDP was 406.45 billion U.S. dollars in 2022, making it the fifth-largest economy in Southeast Asia and 37th in the world. As forecasted by the World Bank, the middle and affluent classes are expected to grow rapidly and account for 20% of the country’s population by 2030. Vietnam’s continued economic development, growth of the middle class, and increasing demand for high-quality healthcare services are crucial drivers for healthcare system here. To upgrade and expand their facilities, improve operational efficiency, and provide better services, they are investing to equip their facilities with advanced medical devices.
According to the Economist Intelligence Unit (EIU), Vietnam’s healthcare expenditure was approximately USD18.5 billion in 2022, representing 4.6% of the country’s GDP.
Together with the birth rate decline, Vietnam’s aging population is resulting in higher demand for healthcare services and products. According to the WHO, non-communicable diseases (NCDs) are an increased mortality and morbidity burden that accounts for approximately 74% of total deaths in Vietnam.
Public and private hospitals in Vietnam are upgrading their facilities and opening new departments for specialty treatment, providing opportunities for U.S. suppliers.
Public hospitals dominate the healthcare system and account for 86% of the total hospital number in Vietnam. However, the Vietnamese healthcare sector is currently facing several challenges:
- Most hospitals are outdated and face chronic overcrowding. Hospitals in Hanoi and Ho Chi Minh City receive up to 60% of the country’s patients and operate at 200% of the capacity.
- Much of the existing medical equipment in public hospitals in Vietnam is obsolete and needs replacement. Many hospitals lack sufficient equipment for surgery and intensive care units.
- Vietnamese public hospitals rely largely on a state budget to upgrade their facilities, equipment, and services. The total budget for the health sector has increased but is still too low to meet the demands.
- A shortage of qualified medical staff is common in many hospitals. Doctors and nurses work under stressful conditions and wages are relatively low.
As high-quality healthcare service is not yet widely available in Vietnam, the Ministry of Health estimates that around 40,000 Vietnamese people spend approximately USD2 billion to travel abroad for medical services every year.
Medical Equipment
More than 90% of medical equipment in Vietnam is imported, and the medical device market was valued at 1.5 billion USD in 2022. The sector is forecast to grow at a Compound Annual Growth Rate (CAGR) of 9.7% from 2021-2026, reaching USD 2.1 billion by 2026.
The Vietnamese government encourages the import of medical equipment because local production cannot meet demands. Imported medical equipment has low import duties and no quota restrictions.
The Ministry of Health of Vietnam (MOH) is responsible for state management of medical devices, implementation of legislative documents, national technical regulations, strategies, policies, and plans on medical devices, conducting inspections, settling complaints/denunciations, and action against violations related to medical devices.
Within the Ministry of Health (MOH), the Infrastructure and Medical Device Administration (IMDA) is a specialized department that advises and assists the Minister of Health in state management and organizes law enforcement on the construction of medical works and medical equipment. The Administration oversees issuing detailed regulations on standards, import licenses, registration numbers for medical devices (Class C and D), Certificates of Free Sales, and medical device price declaration. The Provincial Departments of Health are responsible for the notification of Class A and B medical devices.
On March 3, 2023, Vietnam issued Decree 07/2023/ND-CP (Decree 07), amending and supplementing Decree No. 98/2021/ND-CP on the management of medical devices (“Decree 98”). Decree 07 allows all existing import licenses to be automatically extended to December 31, 2024.
On June 30, 2023, the MOH issued Circular No. 14/2023/TT-BYT regulating methodologies to set up tender prices in public health facilities. The Circular is effective for six months from July 1, 2023, to December 31, 2023 (This is the time for an expected implementing Decree of Tender Law to be issued). This is the first time the value-based purchasing concept has been accepted. If two or more price methodologies are used, the hospital can select the highest bid if technical requirements are met. The Circular also allows hospitals to contact suppliers directly to obtain quotations and acceptance of cases where one supplier is available in Vietnam; it is not required to obtain a minimum of three quotations.
Pharmaceuticals
The pharmaceuticals market was valued at approximately USD 6.7 billion in 2022 and is forecasted to reach USD 8.9 billion by 2026 with a CAGR of 7.3%.
Vietnam’s 2016 Law on Pharmacy, which entered into force on January 1, 2017, is the primary legal framework governing the pharmaceutical sector, including registration, sale, and distribution of pharmaceuticals. Within the MOH, Drug Administration of Vietnam (DAV) is the functional department that oversees pharmaceuticals and cosmetics.
Decree No. 54/2017/ND-CP dated May 8, 2017, provides guidelines for the Law on Pharmacy. The Decree provides stipulation for pharmacy practice certificate; pharmacy business; export and import of drugs; registration of herbal ingredients, excipients, capsule shells; assessment of overseas drug manufacturers; power, method, and procedures for recalling medicinal ingredients; handling of recalled medicinal ingredients; documents and procedures for issuance of the certification of drug advertisem*nt and drug price management.
Decree No. 155/2018/ND-CP date November 12, 2018, amended some articles related to business conditions under state management of the Ministry of Health, allowed foreign companies operating representative offices to establish foreign investment enterprises (FIEs).
On September 5, 2022, the MOH signed Circular 08/2022/TT-BYT (Cir. 08), replacing Circular 32/2018/TT-BYT with an effective date of October 20, 2022. The most notable changes of the Cir. 08 include:
- The Certificate of Pharmaceutical Products (CPP) content requirement: Cir. 08 removed Vietnam-specific requirements and now harmonizes with international practice, specifically the WHO-CPP template
- The CPP’s authenticity verification is no longer a blanket requirement for all dossiers. Instead, a risk-based approach is applied, and that verification can be done via different channels and in parallel with the Marketing Authorization review process.
Leading Sub-Sectors
The demand for investment in medical equipment will continue to increase. The most imported and used medical equipment include consumables, diagnostic imaging, dental products, orthopedics, prosthetics, and patient aids.
A recent BMI report shows that about 90% of medical equipment in Vietnam is imported, with major suppliers from Korea, PRC, Japan, the United States, and Germany, which account for 71% of medical equipment imports. Domestic manufacturers can only meet the demand for basic medical supplies. They produce products such as hospital beds, scalpels, cabinets, scissors, and disposables. They generally offer limited/no warranty or after-sales services, especially in isolated areas of the country.
Other strong areas of growth include operating theaters, emergency equipment, sterilizing equipment, and monitoring equipment.
Opportunities
There are four main classes of medical device purchasers. The largest are government-funded hospitals, which account for 86% of the market. Foreign-owned hospitals and clinics are also large purchasers; however, these facilities usually purchase supplies from their sponsoring country. Local private hospitals will show the strongest growth, while research and educational institutions will also account for some of the demand. Several medical education and research institutions are open to experimenting with new systems and innovative methods. These end-users present an excellent strategic opportunity to develop partnerships, given their desire to explore new technologies.
Large amounts of public funds have been allocated to upgrading hospitals in the provinces. Major national-scale hospital upgrades and construction projects have been approved by the central government.
Vietnam also receives a large amount of international aid in the form of loans and donated medical equipment. Several small projects are currently taking place in Vietnam, including those funded by the World Bank and the EU.
Resources
Medical Devices:
- Decree 07/2023/ND-CP amends Decree 98/2021/ND-CP dated November 08, 2021, prescribing medical device management.
- Decree 98/2021/ND-CP on management of medical devices
- Circular 14/2023/TT-BYT on procedures for determination of budget limits for procurement of goods and services for medical equipment at public health facilities
Pharmaceuticals:
- Law No. 105/2016/QH13: Law on Pharmacy
- Decree 54/2017/ND-CP: Guidelines for Implementation of the Law on Pharmacy
- Decree 155/2018/ND-CP: Amendments to Some Articles Related to Business Conditions Under State Management of the Ministry of Health
- Cir 08/2022/TT-BYT: Regulating the Registration of Drugs, Drug Ingredients
Other:
For more information about the Vietnamese healthcare industry, please contact:
- Ms. Nhung Nguyen, Commercial Specialist
The U.S. Commercial Service, U.S. Embassy in Hanoi
Email: nhung.nguyen@trade.gov
- Mr. Thao Nguyen, Commercial Specialist
The U.S. Commercial Service, U.S. Consulate General in HCMC
Email: thao.nguyen@trade.gov
