The Socialist Republic of Vietnam is a country of over 90 million people and is located on the South China Sea in Southeast Asia, bordering China, Cambodia, and Laos. Since 2000, Vietnam has experienced incredible growth and has been ranked with the highest Global Growth Generators Index among 11 major economies earmarked for investment opportunities by Citigroup.
Healthcare spending in Vietnam is weighed toward the private sector (at 61.3% of total expenditures in 2012) due to a poor level of care by the public health system, which is currently the focus of international aid and grants. As a result of the gaps in the government system, hundreds of thousands of Vietnamese travel for medical care every year at their own expense.
92% of medical devices in 2013 were imported, mainly from Japan, the USA, Singapore, and China, and the market is estimated by the U.S. Department of Commerce at USD $200 million in 2013. The market grew by upwards of 10% per year even through the global recession, and it continues to grow by 5-6%. There is a sore need for upgrades of medical facilities and equipment and the 2013 budget from the Vietnamese government allocated USD $3.9 billion to help the overburdened system accommodate the needs of the population.
THE GOOD NEWS:
A permit to import medical devices in Vietnam can be obtained in 15 working days and at very low cost.
THE CHALLENGE:
A local authorized representative is required to import and distribute devices.
The importation of medical devices in Vietnam is administered by the Ministry of Health through the Department of Medical Equipment and Health Works (DMEHW). A permit is required to import most medical devices into Vietnam. The Vietnamese Ministry of Health has published an approved list of medical devices including 50 types of medical devices in three groups: diagnostic equipment, treatment equipment, and other equipment. If the imported device is already on the list, the entity wishing to import that device must obtain a permit. Medical devices manufactured locally in Vietnam must follow a separate registration process with the Ministry of Health.
Medical devices that are being imported into Vietnam for the first time, and that are not on the approved list, should utilize new methods of diagnosis or treatment and fulfill additional requirements. These devices must satisfy all conditions applicable to devices on the approved list and the technical dossier must also include clinical evaluation results that have been assessed and approved by the Science and Technology Council of the Ministry of Health. However, medical devices recognized by international organizations may be exempt from clinical evaluation requirements. Submitted information includes a current certificate of compliance with ISO 13485 or ISO 9001, a Certificate of Free Sale (CFS), and USA FDA-approval or CE Mark. USA or EU certification will not expedite the certification process. Some of the technical documents and labeling must be submitted in Vietnamese.
Registration must be conducted by a licensed importer who is domestically located. Once all required information has been provided to the authorities in complete and valid form, the permit will be issued in 15 working days and will be valid for one year. Registration fees are usually below USD $200. Locally produced medical devices are issued a Circulation Registration Number (CRN) that is valid for three years.
While Vietnam is participating in the ASEAN (Association of South East Asian Nations) Medical Device Product Working Group, which aims to reduce trade barriers in ten South East member countries through harmonization of regulations, some experts say that it is unlikely that Vietnam will be able to implement harmonization efforts by the 2015 goal.
WHAT YOU NEED TO KNOW:
Medical devices in Vietnam are required to be imported by a licensed importer with a valid permit to import the specific device, which must be renewed each year. With the correct information, a permit can be obtained at low cost in 15 working days.
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