However, due to the high cost and high technological requirements of medical devices, investment and utilization face many difficulties. Most medical equipment in Vietnam is imported due to limited domestic scientific capabilities.
There is an inadequate supply of medical equipment to meet healthcare needs.
Insufficient supply of medical equipment to meet healthcare needs is one of the difficulties and shortcomings in the post-Covid-19 period. This situation arises in most hospitals and clinics nationwide. The current situation is due to various reasons, such as difficulties in procuring medical equipment, especially testing chemicals and fast-consuming supplies, challenges in the procurement bidding process, and the required paperwork for circulation permits. Another factor is the occurrence of misconduct related to the procurement of supplies, drugs, and medical equipment. Therefore, reviewing and evaluating to ensure compliance with legal regulations in procurement is a necessary task.
The Ministry of Health has taken timely measures to address the shortage of medical equipment. For instance, the National Assembly passed Resolution No. 80, allowing the Ministry of Health to extend the registration period for drug circulation, in order to meet the demand for drug supply in the market.
The import process for medical equipment faces many difficulties.
According to statistics, although the medical equipment market in Vietnam has been growing at an average rate of 13.1% over the past 5 years, up to 90% of the quantity is imported. However, the import process is one of the barriers for businesses in supplying medical equipment to the market. The typical import process involves several steps, including estimation, classification, transportation, and customs clearance, with many procedures that need to comply with legal regulations and consume a significant amount of time. In particular, obtaining the circulation permit can take between 15-25 days.
Additionally, imported medical equipment faces high prices due to the application of two tax rates: import tax (0-25%) and value-added tax (5-10%), as well as other associated costs.
The domestic manufacturing capacity of medical equipment in Vietnam is still limited.
In recent years, there has been an increase in domestically manufactured medical equipment, but most of them are from joint ventures. Due to the low quality of technical services in the country, insufficient quantity and expertise of healthcare professionals, and the lack of technological mastery, the output of medical equipment primarily consists of essential and commonly used products that do not require high technology or advanced techniques.
Furthermore, in Vietnam, there is a lack of high-precision technical mold-making factories and extensive testing laboratories for various parameters. As a result, businesses have to import machinery and equipment while also conducting some physical and chemical testing abroad, leading to a prolonged product development process that can take 8 to 10 months for a new product to be launched.
The potential of the in vitro diagnostic (IVD) device market in Vietnam.
The demand for in vitro diagnostic (IVD) products has rapidly increased during and after the Covid-19 pandemic. The in vitro diagnostic market was valued at approximately $76,281.75 million USD in 2021 and is projected to reach a revenue of $101,542.35 million USD by 2027.
The rising prevalence of infectious diseases globally is also a significant factor driving the market's supply and demand. Another crucial factor is the continuous development of IVD diagnostic technologies. There has been a shift from traditional diagnostics to a new generation of molecular biology-based diagnostics, such as polymerase chain reaction (PCR) and next-generation sequencing (NGS).
The supply of IVD products in the Vietnamese market is also constrained by stringent testing standards. Therefore, despite being a promising market, there are not many manufacturers and distributors that meet the required standards. Phacogen Pharmaceutical Joint Stock Company is one of the pioneering companies in Vietnam engaged in the research and production of molecular biology-based diagnostic products according to IVD standards. Phacogen's manufacturing facility operates under a quality management system for medical devices that complies with EN ISO 13485:2016 and is certified by TUV. With investments in modern infrastructure and equipment such as ISO 8 - Class 100000 cleanrooms, conveyor systems, laminators, and cutters for rapid test kit products, as well as an automated mixing and dispensing system (OT2), Phacogen's factory achieves an average production capacity of 1 million test kits per year.
The molecular biology testing kits produced at the Phacogen factory can be widely applied in the fields of cancer, infectious diseases, reproductive health, and forensic examination. Compared to the products currently available in the market, Phacogen's products have numerous outstanding advantages such as assured quality and origin, validated by reputable organizations, competitive pricing, and notably, the ability to timely meet market demands due to full control over the entire production process.
With these superior advantages, the testing products from Phacogen are currently being distributed in hospitals and clinics throughout Vietnam, and there are plans to expand their export to international markets in the near future.
