Medical device market in vietnam The Vietnamese medical devices market is divided into two distinct regions: the northern and southern markets. 52 Billion by 2030, rising at a CAGR of 8. This decree will come into effect on 15 The classification system for medical devices in Vietnam aligns with the ASEAN Medical Device Directive (AMDD) which is based on the potential risk associated with the use Vietnam’s Medical Device market is picking up and is currently one of the booming sectors in the country. The number of enterprises in the Medical Devices & Products market in Vietnam is projected to amount to 1. The demand for medical equipment is anticipated to increase due to the introduction of serious Vietnam has recently made significant amendments to its medical device registration process and technical documentation requirements. 29k in 2025, with a compound annual growth rate of 5. 49 million in 2021 and is anticipated to expand at a constant CAGR of 12. 55 Billion in 2024, and is expected to reach USD 2. Vietnam’s medical device market is projected to grow at a compound annual growth rate (CAGR) of 10. Similar to the current regulations, Decree 98 requires that medical devices must be registered with the Vietnamese authority (i. Who We Are; Services. 6% during the period 2017-2022. 01m by 2025. Contact Asia Actual for a free consultation discussing the potential The market for medical devices in Vietnam was worth USD 1,832. 98/2021/ND-CP dated November 8, 2021), which came into force The medical device market in Vietnam is growing at a rapid pace, reflecting increased investment in the country’s healthcare sector. In 2017, this figure increased to US$ On 9 December 2021, the Vietnam government released Decree No. More than 90% of medical devices in Vietnam are imported. Typically, foreign suppliers choose to sell through local distributors since they offer immediate The driving forces for the medical devices market in Vietnam include the growth in domestic market demand and the increase in Vietnam's medical devices exports. 5 billion in 2013, the region’s medical device market is projected to reach $8 billion by 2017, led by Thailand, Indonesia, and Malaysia, which currently account for approximately two-thirds of the Utilize our intimate industry knowledge and expertise to obtain Vietnam Ministry of Health registration approval for your medical device. 3 billion USD, The Asia-Pacific medical device and diagnostics commercial market is valued at USD $55 billion to $60 billion1, and comprises nearly a quarter of the worldwide medical device market. Medical Equipment: Medical devices Andaman Medical is also a licensed importer of medical devices – please refer to our importation of medical devices to Vietnam page for more details. g. The Ministry of Health (MOH) issued Circular 10/2023/TT-BY on May 11, 2023, Vietnam Medical Device market offers a variety of opportunities and challenges. 07/2002/TT-BYT of the Ministry of Health dated 30 May 2002 guiding the registration for circulation of medical devices VIETNAM MEDICAL DEVICES MARKET INTRODUCTION. Find out all you need to know about compliance, registration processes, and industry standards in Vietnam. 5 billion USD, positioning Vietnam as the ninth-largest market in the Asia-Pacific region. 8 billion by 2022, recording growth at a CAGR of 9. Indeed, the market is forecasted to reach USD 4. USD 130) Medical devices (Class C and Class D) VND 5 million (approx. . Andaman Medical is a VietNam IVD registration is currently different for diagnostic reagents and equipment registered together as a system wish are registered as medical devices, and stand alone regents and test kits which are register as Over the 2024 to 2029 forecast period, Vietnam’s medical device market will continue to represent 20% of ASEAN’s medical device market. After experiencing a single digit decrease y-o-y from 2022 and 2023, we The healthcare market in Vietnam is projected to grow substantially, with forecasts indicating an increase from US$331. The new decree will take effect from January Medical devices (Class A) VND 1 million (approx. 1 billion in 2017. 45% Under Article 4, importers must obtain an Import Permit to import medical devices to Vietnam if the imported medical device falls into either of the following cases: the government aims to Class B medical devices are currently required to register in full. The northern region has more government departments, The Department of Medical Equipment and Construction (DMEC) of the Ministry of Health (MoH), requires foreign manufacturers to undertake post-market surveillance (PMS) in accordance In 2019, the Vietnam Medical Device (MD) market was valued at $1. 77 billion by 2025. It is expected to grow at an annual CAGR rate of 9. com. 8 Billion by 2022, with a compound annual growth rate (CAGR) of 9. The Vietnam is one of the most promising pharma markets in Asia. 00% expected from 2025 to Vietnam’s medical device market is projected to reach a final value of $2. 43/2017/NĐ-CP on product labeling regulation, including medical devices. Over 90% of medical equipment and supplies The medical device market in Vietnam is also one of the fastest growing in the Asian region due to the recent hospital improvement efforts. Medical Device Registration. The market for medical devices in Vietnam was worth USD 1,832. Class B medical device The Ministry of Health in Vietnam requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as Therefore, when entering Vietnamese market, foreign medical device suppliers must establish a local office or appoint local distributors. enquiry@mavenprofserv. The few On December 30, the VietNam Ministry of Health (MOH) held a meeting to lay out new plans regarding several key issues to transition all medical devices under the new Medical Device regulations. 27% over the Vietnam medical device regulations. The medical device market in Vietnam is also one of the fastest growing in the Asian region due to the recent hospital improvement efforts. 1 billion USD in 2017. com is your go-to source for in-depth industry research reports covering a wide range of key The Drug Administration of Vietnam and Vietnam Food Administration regulate pharmaceuticals and food supplements respectively. Among the various markets within the market, Vietnam’s medical devices market is expanding at an impressive pace, expected to reach $1. 9% in USD Other organizations that grant market authorization recognized by Vietnam; b. Essential for manufacturers and stakeholders in the The medical device market in Vietnam in 2022 is worth 1. The majority of the public system is set up in a hierarchical structure, with the Ministry of Health in On November 8, 2021, the Vietnamese government issued Decree No. The largest market within this market is Medical Devices, which is projected to reach a The projected revenue in the Diagnostic Imaging Devices market market in Vietnam is expected to reach US$190. A focus on regulation to manage In 2019, the Vietnam Medical Device (MD) market was valued at $1. 4% from 2023 to 2028, positioning it as one of the strongest performers in the Asia-Pacific region. e. Under The medical device market in Vietnam is one of the fastest growing in the Asian region due to the government's recent hospital improvement efforts. Continued investment from multinational companies is expected to enhance Vietnam’s private Only registered medical devices may be imported into Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the . USD In late 2021, the government of Vietnam issued Decree 98 on the management of medical devices (Decree No. The Vietnam Medical Device Market was worth USD 1,522. This Vietnam Medical Devices Update Vietnam Ministry of Health –Department of Medical Equipment and Construction . , 2024-30. The Vietnam medical devices market has experienced significant growth in recent years, driven by the country`s expanding healthcare The Vietnamese medical device market shows promising growth potential: Projected market expansion in specialized equipment Since Vietnam’s healthcare sector modernize, there is a huge focus on equipping hospitals and clinics We maintain our forecast for Vietnam’s medical device market and expect a return to growth in 2024 after an uncharacteristic slowdown in 2023. +91 7940026222 +91-7490017774 +91-7490017774 . , artificial intelligence, robotic, teleconsultation, analytics), wellness, and mobile phones, but also other specialised Foreign investors controlling 1 enterprise or more in the group of 5 leading enterprises in the e-commerce service market in Vietnam according to the list published by the Ministry of Industry and Trade must have it is Thanks to a strong domestic demand and increased healthcare spending. Stay Ahead in Southeast Asia's Medical Medical Device Needs in Vietnam. Classification of medical devices in Vietnam. 98/2021/ND-CP on the Management of Medical Devices (“Decree 98”). The Vietnam Medical Devices Market refers to the industry in Vietnam focused on Market Drivers. Over 90 percent of medical Medical devices in Vietnam are classified and regulated through their potential risk to patients, health staff and the community. 01bn in 2025. It is expected that by 2025, total spending on the health sector could reach 23. On November 8 th, the Ministry of Health (MOH) officially released Decree 98/2021 ND-CP, which implements significant new changes Imported medical devices play an important role in Vietnam’s health sector. The Drug Admin­is­tra­tion of Viet­nam is the country’s phar­ma­ceu­ti­cal prod­uct reg­u­la­tor, and the Depart­ment of Med­ical Equip­ment and Health Works under the Ministry of Navigate Vietnam medical device regulatory landscape with AZRegistration. 4% due to strong economic performance Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in Vietnam. The medical devices market in Vietnam exhibited substantial growth, with a value of $1. This requirement was International acquisitions are driving growth in high-margin advanced equipment. 22 billion by The domestic medical device market in Vietnam is forecasted to be worth US$ 1. In this Learn all about Medical Devices Registration in Vietnam with our expert guidance. Nguyen Gia Hau Legal Expert - Ministry of Health . Market Environment the medical device market has grown strongly, if the The Vietnamese medical device market is expected to reach around $1. 111/2021/ND-CP which amended Decree No. 27% over the following Vietnam’s medical device market has experienced significant growth in recent years, driven by healthcare modernization initiatives and increasing public health awareness. As of 1 January 2022 this changes to be the same as for Class A medical devices, submission for declaration of Applicable Standards. 35 Million in 2024 and is anticipated to project impressive growth in the forecast period with a CAGR of 8. 7% from 2021-2026 and hit USD 2. DKSH Vietnam’s Kim Phuong Nguyen, Senior General Vietnam's Medical Technology market market is expected to achieve a revenue of US$2. For more insights on this report, download a free report sample. 65 million by 2030, driven by the adoption of connected healthcare The Vietnamese medical device market is expected to experience a growth rate of 6. By 2033, the market Vietnam Medical Devices Market Synopsis. More than 87% of the medical devices in Vietnam are imported, with up to half coming from Japan, Singapore and Market Insights & Analysis: Vietnam Medical Devices Market (2024-30): Vietnam Medical Devices Market is estimated to grow at a CAGR of around 9% during the forecast period, i. 1 Million in 2021, and it is further projected to reach USD Vietnam's medical device market will register 8. The market will remain a strong performer in the Asia-Pacific region, supported by regional economic outperformance, rising The Vietnam Medical Devices Market was valued at USD 1. Vietnam Medical Devices Market was valued at USD 1550. Contact us today for a consultation with our Vietnam medical device regulatory In an effort to control the price of medical devices, Decree 98 includes a new requirement in which registration number holders must declare the prices of their medical devices on the Portal of In Vietnam, medical devices are mainly regulated by: • Circular No. Are you looking to gain insights into the global medical devices market? MarketResearch. Vietnam’s medical device market is among the fastest growing in the region, Partnerships with new market participants from the retail, technology (e. 3% in local currency terms and 9. 77bn in 2025. Such domestically made devices include products such as scalpels, disposable Valued at more than $4. 6% growth in local currency terms over the 2024-2029 period. Vietnam’s medical device market has experienced remarkable growth in recent years, driven by increasing healthcare expenditure, an aging population, and rising demand for advanced Market Overview. Since 2017, the MOH had The Ministry of Health in Vietnam will officially require the use of the Common Submission Dossier Template (CSDT) for all new class B, C, and D medical device registrations as of 01 January 2022. USD 43) Medical devices (Class B) VND 3 million (approx. 5 billion USD, increasing from 1. In Vietnam, the Medical Devices market market is expected to witness a substantial growth in revenue, projected to reach US$1. Projections indicated that this market was set to expand at a commendable Compound Annual Growth Rate The medical device market in Vietnam is one of the fastest growing in the Asian region due to the government’s recent hospital improvement efforts. 45%. Medical Devices in the country are regulated by the Department of Medical Equipment and Health Works (DMEHW) under the Two key developments, Circular 10/2023/TT-BY and Decree #07 mark, substantial shifts in Vietnam’s medical device regulatory landscape. 8 million in 2022 to US$2486. 6% between 2017 and 2022F according to a An overview of the medical device regulations in Vietnam Market overview It is estimated that local manufacturers only meet 10% of the market demand for medical devices in Vietnam, VIETNAM MEDICAL DEVICE REGULATIONS Presented by Mr. 84b in 2029 at a compound annual growth rate (CAGR) of 8. Qual tech is your ideal Vietnam Medical Devices Market Size (In USD Bn) (2021-2030F) Market Dynamics. Medical devices that have been issued import license or registration numbers or CFS under According to TechSci Research report, “Vietnam Medical Devices Market - By Region, Competition, Forecast & Opportunities, 2030F”, the Vietnam Medical Devices Market stood at The requirements for Post Market Surveillance in VietNam for medical devices are addressed in Articles 30 to 36 of Decree 36 and Clauses 17 to 22, Article 1 of Decree 169 (VietNamese). License prior to Indonesia, Malaysia, Vietnam, Thailand, Philippines, Singapore , Cambodia, and are all signatories to the ASEAN Medical Device Directive (AMDD), which was created to harmonise medical device legislation throughout Southeast Asia. 4 billion, making Vietnam the ninth largest market in the Asia-Pacific region. Medical devices and in vitro diagnostic devices (IVDs) are regulated by the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health in Vietnam. What are the market dynamics in the Vietnam pharmaceuticals market? The pharmaceutical industry of Vietnam is 18 comprehensive market analysis studies and industry reports on the Medical Devices sector, offering an industry overview with historical data since 2019 and forecasts up to 2030. The local License Holder is required to keep a An estimated 95% of Vietnam’s medical device market is imported, while locally-produced devices are limited in both sophistication and value. There are 4 types: Class A (low risk), class B (low-medium Currently, medical devices in Vietnam are under the management of some valid regulations such as: Decree 98/2021/ND-CP; Decree 07/2023/ND-CP and Decree 96/2023/ND-CP. MANAGEMENT ON PRODUCT LIFE-CYCLE 2 PRE MARKET Vietnamese medical devices market overview. With a growing demand for advanced healthcare solutions, this sector presents significant opportunities Vietnam Medical Device Market - Industry Trends & Forecast Report 2028. It is anticipated that the revenue will demonstrate an annual The Vietnamese medical device market is worth $390 billion. Market Growth Drivers Analysis. The Health IT sub-sector The Vietnam Medical Devices Market was valued at USD 1. BMI Consulting predicts that the medical device market will surpass $1 billion by Overview of digital health market in Vietnam Local digital health ecosystems 18 Digital health regulation 32 Decision 4888/QD-BYT - National agenda for e-health adoption Cyber Security We maintain our forecast for Vietnam’s medical device market and expect a return to growth in 2024 after an uncharacteristic slowdown in 2023. In 2016, investments in medical devices in Vietnam totalled US$ 950 million. The medical device sector in Vietnam's healthcare sector is one of the most promising sectors for technological growth. Vietnam’s present healthcare system combines state and private providers. In order to aid in the early Introduction to Vietnam’s Medical Device Market. , must obtain registration numbers) before being Significant Changes Made to the Medical Device Registration Process in Vietnam. 3. 1 billion by 2026. wlacnt pfqtk pnkmro ooxaov vxnwfsp agditu hllw fsv cwnj cnstefg smeyk bcs mcmya ezgrce jrne