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MedTech in Vietnam: Market entry and licensing requirements for foreign investors.

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Medtech in vietnam: market entry and licensing requirements for foreign investors

Vietnam’s MedTech industry, characterised by innovative medical technologies and rapidly growing healthcare demands, is an emerging market attracting global attention. As this sector evolves, navigating its complex legal landscape becomes crucial for businesses and investors. Understanding the intricate legal framework governing MedTech in Vietnam is essential, not only for compliance but also for leveraging opportunities in this dynamic environment.

This article aims to provide a comprehensive overview of the legal nuances specific to the MedTech sector in Vietnam, shedding light on both the challenges and the avenues for legal support.

Growth opportunity

Vietnam’s MedTech industry is currently in a phase of rapid expansion. The convergence of technological advancements and increasing healthcare demands, propelled by a growing middle class and heightened health awareness, has created fertile ground for MedTech development. In recent years, the sector has seen significant investments, both domestic and foreign, leading to the introduction of cutting-edge medical technologies in Vietnamese healthcare facilities.

Two primary factors fuel this growth. Firstly, the Vietnamese government’s supportive policies, including incentives for healthcare investment and innovation, have laid a strong foundation for the sector’s development. Secondly, foreign investment plays a pivotal role. International companies, attracted by Vietnam’s stable economic growth and favorable investment conditions, are increasingly participating in the MedTech market, bringing in not only capital but also technical expertise.

MedTech definition and relevant segments in Vietnam

In Vietnam, Medtech is generally defined as the application of innovative, creative and modern technologies in the medical sector to provide customers with transparent, efficient and convenient medical services at a lower cost than traditional service systems. According to the Portal of the Ministry of Science and Technology, MedTech provides a variety of solutions for both patients and hospitals, from online patient management software, automatic health monitoring, direct examination scheduling, etc. to providing remote medical solutions, virtual reality medical examination, etc. to meet the needs of patients without needing to go to medical agencies. It includes the following main segments:

A. Telemedicine

Both telemedicine and teleconsultation are modern approaches in the healthcare field, leveraging technology to provide remote healthcare services. They help improve the quality of care and enhance access to medical services for everyone.

Telemedicine is a concept related to the provision of healthcare services through information and communication technology. Telemedicine (so-called Remote Healthcare) involves the use of communication technology to provide and support healthcare at a distance. It encompasses remote diagnosis, treatment, patient monitoring, as well as consultation and health education via telephone, video, apps or other communication mediums. In practice, some telehealth providers also prescribe and sell pharmaceutical products. (e.g., Med247)

B. Healthcare Information Systems and Software

Healthcare Information Systems (HIS) and software play a pivotal role in modern healthcare by enhancing the efficiency, accuracy, and quality of medical services. Below are the main segments:

  • Electronic Health Records (EHRs): Digital versions of patients’ paper charts, providing real-time, patient-centered records. They contain medical histories, diagnoses, medications, treatment plans, immunisation dates, allergies, radiology images, and lab test results.
  • Practice Management Software: Helps in managing daily operations such as appointment scheduling, billing, and reporting.
  • Clinical Decision Support Systems (CDSS): Offer clinicians, staff, patients, and other individuals with knowledge and person-specific information, intelligently filtered and presented at appropriate times, to enhance health and health care.

C. Telemedicine Platforms

A Telemedicine platform is an E-commerce platform that combines the convenience of online shopping with healthcare services, allowing patients to find and consult with appropriate healthcare providers remotely, transforming how healthcare services are accessed and delivered. Note that the platform provider commonly does not provide telemedicine service.

D. Manufacturing medical equipment by applying high-technology

Medical equipment such as X-rays, CT scanners, etc. is considered high-technology products. They also applied AI, and robotics during the manufacturing process.

MedTech Legal Framework in Vietnam

Despite the absence of a specific, robust regulatory framework for MedTech, it can be categorised into three primary sectors: medical, e-commerce, and information technology. Consequently, the legal landscape for MedTech is shaped by an amalgamation of laws and regulations pertaining to medical, pharmaceutical, e-commerce, and information technology sectors. This complex legal environment underscores the interdisciplinary nature of MedTech and the need for comprehensive regulatory oversight.

Market entry for foreign investors in MedTech

In Vietnam, both local and foreign investors are limited to providing services/ business lines within their registered scope. Unlike the local investors, there are certain market access limitations for foreign investors, especially in the fields that are considered “sensitive”. Vietnamese authorities will rely on the below levels of legal framework to issue the approval for investment activities of foreign investors in the form of a license. In particular:

  • Level 1: Free trade agreements and other international treaties to which Vietnam and the home country of the foreign investor are members (International Treaties)
  • Level 2: Vietnamese laws

When assessing market entry business lines and conditions relevant to the 4 MedTech industry segments based on investors’ operational objectives in Vietnam, the following conditions and market entry regulations generally apply:

SegmentOperational objectiveBusiness linesMarket entry
Telemedicine and teleconsultingHospital services, dental services and medical services (CPC 9312)General, specialised and dental clinic operations (VSIC 8620)

Other medical activities not yet classified (VSIC 8699)

For member countries of WTO

Foreign investors are allowed to provide services through the establishment of (i) 100% foreign-invested hospitals, (ii) joint ventures with Vietnamese partners or (iii) through business cooperation contracts.

The minimum investment capital for a hospital is 20 million USD, a general clinic (polyclinic) is 2 million USD and a specialised treatment facility is 200 thousand USD.

For member countries of AFAS, EVFTA, UKFTA:

100% foreign-owned company and no requirement of minimum investment capital.

Retail sale of pharmaceuticalsPharmaceutical retail (VSIC 4772)Under International Treaties, Vietnam has not committed to opening a market for the distribution of pharmaceuticals.

Decree 54/2017/ND-CP allows foreign-owned companies to import pharmaceuticals but not distribute (retail, wholesale) pharmaceuticals, except for drugs and medicinal ingredients produced by their own facilities in Vietnam.

Healthcare Information Systems and SoftwareComputer services and related services (CPC 841-845, CPC 849)Computer programming (VSIC 6201)

Computer consultancy and computer system management (VSIC 6202)

Information technology service activities and other services related to computers (VSIC 6209)

Under Vietnam’s commitment to WTO, foreign investors from WTO member states are allowed to establish a 100% foreign-owned enterprise to conduct IT-related activities, such as computer programming, data processing, software implementation, etc.,
Telemedicine PlatformE-commerce platform for medical servicesWeb Portal (VSIC 6312)According to International Treaties, Vietnam has not committed yet to market entry of foreign investors.

According to Decree 52/2013/ND-CP, amended by Decree 85/2021/ND-CP:

1. Foreign investors invest and do business in providing e-commerce services in 02 forms:

a. Invest in establishing economic organisations

b. Invest capital, buy shares, buy capital contributions

2. 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 an appraisal opinion on the safety national security of the Ministry of Public Security (determined based on the criteria of number of visits, number of sellers, number of transactions, total transaction value)

In particular, a foreign investor is considered to dominate an enterprise providing e-commerce services according to the above regulations when falling into one of the following cases:

a. Foreign investors hold ownership of more than 50% of the charter capital or more than 50% of the voting shares of the enterprise

b. The investor directly or indirectly decides to appoint, dismiss or dismiss the majority or all members of the board of directors, chairman of the board of members, director or general director of the enterprise

Investors have the right to decide important issues in the enterprise’s business operations, including the choice of technology platform and form of business organisation; choose industry, profession, location, and form of business; choose to adjust the scale and business lines; choose the form and method of mobilising, allocating and using business capital of that enterprise.

Manufacturing medical equipmentServices related to manufacturing (CPC 884 and 885)Manufacture of medical, dental, orthopaedic and rehabilitation equipment and instruments (VSIC 3250)100% foreign-owned company is allowed

Conditions for investors operating MedTech activities in Vietnam

In order to operate within the aforementioned MedTech sector, Foreign Invested Enterprises (FIE) are expected to adhere to specific requirements. These primarily pertain to the domains of telemedicine, telemedicine platforms, and the manufacturing of medical equipment.

Contrarily, the Healthcare Information Systems and Software sector is fundamentally an IT industry and not a conditional business. Therefore, the operation of services within this sector does not necessitate compliance with specific requirements.

However, Article 87 Decree 96/2023/ND-CP requires any Telemedicine services provider to satisfy the following requisites:

  • Must be established under the forms regulated under Article 39 of Decree 96/2023, such as hospital, clinic, medical station, traditional medicine diagnosis and treatment room, familial medical examination and treatment facility, etc.
  • Must obtain the Operating License and provide service within the scope of service under this license
  • Telemedicine providers are only allowed to diagnose and treat diseases that are included in the List of diseases and medical conditions eligible for telemedicine as stipulated in Circular 30/2023/TT-BYT, such as:
SpecialistDisease, medical condition
NutritionObesity
Ear, nose and throatAcute nasopharyngitis
HeartHypertension
  • Services must be performed by a practitioner qualified by License to practice medicine
  • Must have technical infrastructure, information technology equipment, specialised equipment, information technology software suitable for the type of service provided and ensuring the transmission, display, processing and storage of data are safe and secure. Ensuring that data storage and backup time meet legal regulations
  • Must announce the eligibility to conduct telemedicine

Should a telemedicine provider independently develop a platform or website to offer their services, they must not only comply with the requirements imposed on telemedicine but also adhere to the stipulations of the Announcement of the website and mobile applications to the Ministry of Industry and Trade. This announcement typically necessitates the provider to inform the authority about their website and mobile application. The objective of this disclosure is to keep the authority apprised of the services being rendered, their extent, and any modifications or updates.

Regarding the Telemedicine platform model, the platform operator merely takes the role of an owner of such e-commerce platform and the website or mobile app is a platform to connect qualified medical service providers and the patients. The medical service provider will take direct responsibility regarding the service/product quality as well as obtaining the necessary licenses to bring these products into the Vietnamese market legally and compliantly.

In accordance with the regulations, the proprietor of an e-commerce platform, who does not directly offer medical services or goods, is not required to fulfil the prerequisites imposed on medical services as outlined above. The platform owner will generally register for IT and e-commerce-related business lines. However, e-commerce is a conditional business line, and the operator must secure a trading license under Decree No.09/2018/ND-CP and register their website with the Ministry of Industry and Trade (MOIT). Each platform that is successfully registered with the MOIT will be granted a red tick, which must be displayed on its website.

Red tick

Notable regulations on personal data processing

On 17 April 2023, the Government issued Decree No. 13/2023/ND-CP on personal data protection (Decree 13) which will take effect from 1 July 2023. Decree 13 applies to all domestic or foreign organisations and individuals involved in the processing of personal data in Vietnam (e.g. employees, customers, suppliers, users or individuals), even if the processing of personal data is carried out outside Vietnam.

According to the definition in Decree 13, personal data processing refers to one or multiple activities that impact personal data, including collection, recording, analysis, confirmation, storage, rectification, disclosure, access, traceability, copying, sharing, transmission, provision, transfer, deletion, destruction, or other relevant activities. While operating the telemedicine platform, the system will record, process, store, and transfer personal data of the patient and the medical service providers. As a result, the telemedicine platform provider is considered a personal data processor and is subject to Decree 13.

Decree 13 imposes many requirements on parties involved in data processing activities. Here are some key regulations that might be imposed on enterprises regarding personal data processing:

  • Consent Requirements: Enterprises may be required to obtain explicit consent from individuals before collecting, processing, or storing their personal data. The consent should be informed, specific, and freely given.
  • Purpose Limitation: Enterprises must collect and process personal data only for specified, explicit, and legitimate purposes. They should not use the data for purposes beyond what was consented to by the individuals.
  • Data Minimisation: Enterprises should only collect and process personal data that is necessary and relevant for the purposes for which it was collected. They should minimise the amount of data collected and retain it only for as long as necessary.
  • Data Security Measures: Enterprises are usually required to implement appropriate technical and organisational measures to ensure the security of personal data against unauthorised access, disclosure, alteration, or destruction.

In summary, telemedicine involves the processing of personal data to deliver remote healthcare services effectively while maintaining patient privacy and confidentiality. It’s essential for telemedicine platforms to implement robust data protection measures and adhere to regulatory requirements to ensure the secure handling of personal data.

Please visit https://vietnam.acclime.com/news-insights/personal-data-protection-obligations-in-vietnam-decree-13-legal-framework-and-2023-obligations for details and guidance to comply with Decree 13.

Manufacturing of medical equipment is covered by Decree 98/2021/NĐ-CP promulgated by the Vietnamese government, which establishes consolidated regulations over medical equipment, whether domestically manufactured or imported. According to this decree, it is mandatory for every medical device to undergo a specific registration process and obtain authorisation from the Ministry of Health. Moreover, medical devices are to be systematically classified based on their risk level. As the level of risk escalates, the regulatory requirements intensify. The details of this are presented in the following table:

ClassificationLevel of riskCompliance procedure
ALowDeclaration of applicable standards
BLow to moderateDeclaration of applicable standards
CModerate to highCirculation registration
DHighCirculation registration

The medical equipment manufacturer also needs to comply with ISO 13485 and carry out the declaration of eligibility for the manufacture of medical devices according to Article 8, 9 of Decree 98/2021/ND-CP.

Where manufacturers apply high technology know-how in the medical equipment production processes in Vietnam, investors have opportunities to apply for tax incentives, particularly, enjoying a CIT rate of 10% in 15 years, CIT exemption for 4 years and 50% CIT reduction for the next 9 years. Nonetheless, manufacturers are required to meet the prevailing conditions to be deemed as a ‘High Technology Enterprise’ by obtaining a High-Tech Enterprise Certificate, or to be recognised as applying high-tech by attaining a High-Tech Operation Application Certificate.

Challenges and Opportunities in the Legal Landscape

Navigating the legal framework in Vietnam’s MedTech sector presents several challenges. Companies often face complexities in regulatory compliance, particularly in product registration and licensing processes, which can be time-consuming and require detailed technical documentation. Additionally, frequent updates and changes in regulations demand continuous vigilance and adaptability from MedTech businesses.

These challenges, however, open doors for specialised legal support. Consultants with expertise in MedTech regulations can provide invaluable guidance, helping companies navigate through the regulatory maze. From ensuring compliance with the latest laws to representing businesses in legal proceedings, legal professionals play a crucial role.

 

If you need any assistance with these or any other matters with respect to MedTech licensing and market entry provisions in Vietnam, to ensure you are compliant and protected in the market, our experts are ready to support you.

Huy Nguyen, Senior Associate Licensing | Market Entry and Corporate Services – huy.nguyen@acclime.com

Phuong Vo, Manager Licensing | Market Entry and Corporate Services – phuong.vo@acclime.com

Rizwan Khan, Managing Partner – r.khan@acclime.com

Updated on March 5, 2024

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