Law on horizon for life-saving equipment

According to the Ministry of Health (MoH), the Health Strategy and Policy Institute is working on a draft law and assessing regulations on medical equipment management, which is expected to be completed in June and submitted to the government before the end of the year.

An MoH official told VIR, “The draft outlines updated regulations and requirements for the industry. It aims to streamline the regulatory framework, enhance market oversight, and improve the safety and efficacy of medical devices available in Vietnam.”

For instance, the draft stipulates policy on medical device management, development of manufacturing, classification and clinical trials, circulation, advertising, and more.

It also provides several definitions, with clarification on in vitro medical devices, spare parts, business units, refurbished devices, and repairs.

Regarding circulation registration, class A medical devices will undergo procedures for declaring applicable standards and will be managed by the provincial department of health. Class B, C, and D devices will be registered for circulation and managed by a specialised agency under the MoH’s Infrastructure and Medical Device Administration.

Circulation licence holders must establish a quality management system suitable for the product and maintain effective operations; and report any changes in the design, materials, manufacturing processes, scope of application, and method of use of registered devices that may affect safety, quality, or effectiveness.

Despite the expected changes, concerns are still being raised. Health expert Hai Ngo said, “The first law on medical devices is being drafted amid limited personnel resources. Thus, more consideration should be made to ensure that new regulations align with international practices, otherwise it can cause new barriers to the business community.”

Health expert Hoa Duong added, “A lengthy authorisation process hampers the development of local companies as it takes longer for them to respond to the market. Therefore, this issue should be solved comprehensively in the draft.”

Medical devices in Vietnam are under the management of various regulations. Last year, Decree No.96/2023/ND-CP brought fresh air to the business community and eased some concerns over marketing authorisations for such devices by having regulations on prioritising processing of device registration applications for some certain cases.

Decree 96 also solved issues related to a lack of regulations on prioritising processing for advanced medical equipment, systems and technologies in previous decrees, which caused a backlog for Class C and D device dossiers.

According to experts, Vietnam still relies heavily on imported medical equipment, presenting opportunities for international manufacturers to capitalise on demand through strategic distribution channels.

Key market players include Stryker Vietnam, USM Healthcare, MEDEP JSC, Omron Healthcare Manufacturing Vietnam, B. Braun Vietnam, and Armephaco, among others.

The Vietnam medical devices market focuses on the production, distribution, and usage. It encompasses a wide range of products such as diagnostic equipment, surgical instruments, medical consumables, and more. This market is experiencing growth driven by factors like increasing healthcare expenditure.

In February, Canadian biotechnology company Gene Bio Medical signed an MoU with Binh Dinh Pharmaceutical Medical Equipment to establish a large-scale production facility in the south-central province of Binh Dinh.

The partnership aims to manufacture high-quality diagnostic test kits using Canadian technology, catering to markets in Vietnam, Southeast Asia, the Middle East, and North America.

In March 2024, the US Trade and Development Agency assisted Vietnam in developing regulations designed to enhance its capacity to procure high-quality medical devices from US manufacturers. This collaboration aims to improve the quality of healthcare in Vietnam while facilitating smoother procurement processes, ultimately fostering stronger ties between the two nations’ medical device sectors.

Competitors have already begun entering Vietnam via acquisitions. In 2023, Singapore’s Raffles Medical Group announced it would acquire a majority stake in the American International Hospital in Ho Chi Minh City. Additionally, Thomson Medical entered the market by acquiring the country’s largest private hospital, Far East Medical Vietnam, for $382 million in 2023.

According to TechSci Research, Vietnam’s medical devices market was valued at around $1.55 billion in 2024 and is anticipated to project impressive growth in the forecast period with a compound annual growth rate of 8.45 per cent through to 2030.