Healthcare markets in Asia: updates on the medical device market in Vietnam

Ames Gross

Pacific Bridge Medical

Concluding his ‘Healthcare markets in Asia’ series, Ames Gross shares an update on the Vietnamese medical device industry.

(Continued from “Healthcare markets in Asia: updates on the Chinese medical device industry“)

Introduction

With its 87 million people and a fast growing economy, the healthcare market in Vietnam is growing. The Vietnamese government has also made some type of health insurance mandatory for all citizens in late 2009, and plans to have universal health coverage by 2016. The government has also pledged roughly $2 billion to construct more general and specialized medical institutions in less developed areas by 2014.

The private healthcare market in Vietnam has also been growing strongly after the government removed the ban on private practices in the late 1980s. Whenever possible, the Vietnamese people will opt for private healthcare over public, as the quality of facilities and services in the public sector is still poor.

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“The private healthcare market in Vietnam has also been growing strongly after the government removed the ban on private practices in the late 1980s.”

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Medical device market size

The Vietnamese medical device market is worth $390 billion. More than 87% of the medical devices in Vietnam are imported, with up to half coming from Japan, Singapore and China. Vietnam does manufacture some medical devices locally, but they are mostly non-sophisticated devices such as low level hospital beds and syringes. The medical device market is expected to further grow at 14% a year, approaching $1 billion in about 10 years.

Vietnam medical device regulations

Vietnam medical device regulations are under the jurisdiction of the Department of Medical Equipment and Health Works (DMEHW) within the Ministry of Health (MOH). In addition, locally manufactured medical devices are regulated by the Ministry of Science and Technology (MOST).

In the past, foreign medical device companies were only allowed to sell their devices through local wholesale distributor firms. These local firms would then distribute to smaller distributors in their network. However, this restriction was removed at the end of 2008, and some foreign medical device companies have now set up their own distribution in Vietnam.

Vietnam medical device regulations state that all medical devices are required to have labels that must either be in French or English, in addition to the compulsory Vietnamese labels.

Import license

The registration process for medical devices in Vietnam is different for medical devices which are imported and those which are manufactured locally. Devices which are imported are not required to be registered. Instead, a product specific import license will suffice. To obtain a product specific import license, foreign medical device companies are required to submit a quality declaration letter, a quality control certificate (US FDA, ISO, etc), the original product catalog, the instructions manual containing technical specifications (with their Vietnamese translation), as well as a certificate of free sales from the device’s country of origin.

Devices which have already obtained foreign approval (FDA or EC) can expect to receive a decision in three weeks if the required documents have been submitted according to Vietnam medical device regulations.

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“The medical device market is expected to further grow at 14% a year, approaching $1 billion in about 10 years.”

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Registering locally manufactured medical devices

As mentioned, locally manufactured medical devices are required to be registered under Vietnam medical device regulations. The documents required for locally manufactured medical devices include the quality standards, methods of testing, the device’s composition breakdown listing all its chemical ingredients and operational license with safety, quality and hygiene standard testimonies or cosmetic good manufacture practice certificate.

In addition, the business registration certificate or investment certificate for the organization or individual who is registering the product is also required. Vietnam medical device regulations state that if the individual or organization registering the product is not the manufacturer of the medical device, a certificate of mandate signed by the manufacturer is then required. All these documents should be in either Vietnamese and / or English. Each product family needs only one dossier.

Registration fees

Locally manufactured medical devices can expect to pay around $20 to register each product. Imported medical devices operate on a tiered service fee, where devices costing less than $65,000 will be charged a $30 fee, devices between $65,000 and $200,000 will be charged a $65 fee, and devices costing more than $200,000 will be charged a $190 fee.

Clinical trials

Generally, applications for imported medical devices can expect a reply from the Department of Medical Equipment and Health Works (DMEHW) within three weeks, unless the medical device requires local clinical trials. Local clinical trials are required if the medical device is the first of its kind to be imported, is used for a new therapy or has a new function.

Medical devices companies can opt to submit the foreign clinical trials of their medical devices for registration. These devices must have received the approval of the foreign country’s medical regulatory agency. Lastly, these devices must also be registered in their country of origin. Nonetheless, the need for local clinical trials is up to the Science and Technology Council within the Ministry of Health (MOH).

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“The best opportunities for medical devices in Vietnam are those which help fight liver cancer, diabetes, orthopedics and cardiovascular diseases.”

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If the MOH decides that foreign medical device companies must conduct clinical trials in Vietnam in order to register their medical devices, the MOH will implement the testing. These clinical trials will not be sponsored by the foreign medical device manufacturer or distributor. These clinical trials will normally take up to twelve months.

Similarly, for medical devices which have yet to perform any clinical trials – whether in Vietnam or their country of origin, the DMEHW will then implement local clinical trials. In this case, the company which is applying will have to prepare the clinical trial protocols.

After the clinical trials, the hospitals which have conducted the trials will submit the results to the Ministry of Health and the medical device company. The medical device company will then have to submit their registration approval with the clinical trial results. A decision can be expected within 3 weeks after submission.

Market opportunities

The best opportunities for medical devices in Vietnam are those which help fight liver cancer, diabetes, orthopedics and cardiovascular diseases. Devices which will be strong areas of growth include operating theaters, emergency equipment, sterilizing equipment, patient monitoring equipment and imaging diagnostic equipment such as CT scanners, color ultrasound machines, MRIs and X-ray machines.

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pharma-PPM-toolbox-5-6-March-2013

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About the author:

Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asia market. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit http://www.pacificbridgemedical.com.

What opportunities are there for medical devices in Vietnam?