Vietnam’s 2012 GDP growth rate was about 5 percent, down from 7 percent in 2010. But its economy is still very strong compared to the West, where growth rates have ranged from 0 to 2 percent. Vietnam’s medical device market is expanding rapidly. The market — valued at $634 million in 2012 — is expected to grow 18 to 20 percent from now through 2017.
Quick growth in the medical device sector comes from the increased demands of an expanding middle class and increasing national investment in Vietnam’s healthcare sector. Per capita spending on healthcare in Vietnam remains small compared to other Southeast Asian countries. But the spread of national health coverage means that more Vietnamese will be able to afford better healthcare services and products.
Since 2009, some healthcare coverage has been mandatory for all Vietnamese. Following the model of Thailand, Vietnam has been implementing its own national healthcare scheme. Currently, 64 percent of Vietnam’s 90 million people are covered under it. By 2015, the Ministry of Health (MOH) wants to cover 75 percent of citizens 90 percent by 2020.
Meanwhile, the government is making significant investments in national healthcare infrastructure. In its 2013 healthcare budget, the MOH has set aside funding for new facilities and upgrades to existing facilities in mountainous and disadvantaged areas. From 2009 – 2013, it said that it invested $2.5 billion in such infrastructure improvement.
Since the ban on private healthcare practice was lifted in 1989, most Vietnamese have viewed public-sector hospitals as a poor second choice to private facilities. People who can afford private care tend to use it: as of 2011, an estimated 62 percent of healthcare expenditures were private in Vietnam.
MEDICAL DEVICE REGULATIONS
The Department of Medical Equipment and Health Works (DMEHW) under Vietnam’s MOH regulates medical devices. The Ministry of Science and Technology also performs regulatory functions for some domestically made medical devices.
Prior to 2009, only domestic companies were allowed to act as distribution agents in Vietnam. Foreign medical device companies sold their products to local Vietnamese wholesalers, who would either distribute the products themselves, or use a network of smaller distributors. After January 1, 2009, wholly foreign-owned companies have been allowed to distribute their own medical devices in Vietnam.
All devices sold in Vietnam must be labeled in English and Vietnamese or in French and Vietnamese.
Medical device registration in Vietnam is different for domestically manufactured devices and imported devices. While domestically manufactured devices require product registration, imported devices do not.
DOMESTIC DEVICE REGISTRATION
Locally manufactured devices must be registered with the DMEHW. Registration materials must be submitted in either Vietnamese or English, and must include the following:
- A business registration certificate or an investment certificate from the organization or individual registering the product
- An operating license that shows compliance with safety, quality and hygiene standards or a cosmetic Good Manufacturing Practice (GMP) certificate
- A certificate mandating the registration agent, signed by the manufacturer
- A detailed listing of all chemical ingredients in international nonproprietary or generic names, together with their percentage or concentration in the product
- Methods of testing and quality standards
The fee for medical device registration is about $20 per product.
Imported devices that do not need a product registration still require an import license. Required documentation for an import license includes the following:
- An original product catalogue
- An instruction manual and technical specifications for each device (along with Vietnamese translations)
- A quality control certificate (from either the US Food and Drug Administration, the European Commission, or an equivalent body; ISO certification also works)
- A free sales certificate from the country of origin
- A quality declaration letter
Fees for import permits are classified into three tiers: $30 for medical devices costing less than $64,000; $60 for devices priced between $64,000 and $191,000; and $190 for devices worth more than $191,000.
When foreign medical device companies submit correct documentation for FDA or EC approved devices, processing is very rapid. Positive or negative responses typically come within three weeks. However, if clinical trials are required, processing is delayed until trials are completed.
If a medical device has a new therapy, a new function or if it is the first of its kind imported into Vietnam, it may have to undergo clinical testing.
In some cases, foreign clinical trial results may be acceptable. The results must be accepted by the medical regulatory agency of the foreign country. The MOH Science and Technology Council must also examine the results before a device can be approved.
Should the MOH determine that local clinical trials are necessary, the MOH will act as the sponsor of the trials. Trials typically take place in three or more hospitals, and — depending on the device tested — may take anywhere from three to 12 months, or even longer.
While the DMEHW arranges for local clinical trials, the applicant must prepare all clinical trial protocols. After the trial is over, hospitals submit the results to the DMEHW and the applicant. At this point, the applicant must resubmit the medical device application along with the trial results. The DMEHW should issue its decision within 15 working days.
MEDICAL DEVICE PROSPECTS
Vietnam’s rapidly growing medical device sector is driven largely by imports, which made up more than 93 percent of the market in 2011. Devices from Japan, China, Singapore and the U.S. constituted more than half of all medical imports in 2011. Local production is still limited to low end items like hospital beds and syringes. Device shortages are commonplace.
With Vietnam’s population increasingly burdened by non-communicable and lifestyle diseases, the need for medical equipment to treat diabetes, liver cancer and cardiovascular diseases is quite high. Other devices in high demand include: orthopedic products, imaging diagnostic equipment (such as CT scanners, X-ray machines and magnetic resonance imaging machines), operating theaters, emergency equipment, sterilizing equipment and patient monitoring equipment.