Market Intelligence
Medical Devices Vietnam

Vietnam Medical Device Registration

In 2019, the Vietnam Medical Device (MD) market was valued at $1.4 billion, making Vietnam the ninth largest market in the Asia-Pacific region. Over 90% of medical equipment and supplies are imported into the country.  The sector is forecast to grow at an average rate of over 10% each year over the next five years. 

What types of companies can import Medical Device to Vietnam: 
Only companies with a legal business entity registered in Vietnam and that have an import license are eligible to import medical equipment. 

Medical Device Management Stakeholders:
-    The Ministry of Health (MOH) is responsible for the implementation of legislative documents, strategies, policies and plans regarding medical devices. Within the MOH, the Department of Medical Equipment and Construction (DMEC) oversees issuing import licenses, registration numbers for medical devices (Class B, C, and D), Certificate of Free Sales, and confirming advertising content.  
-    The Provincial Department of Health is responsible for the notification of Class-A medical devices. 
-    The Ministry of Science and Technology (MOST) performs regulatory functions for the standard and quality of goods and labeling.
-    The Ministry of Finance issues regulations on management and use of fees and charges related to medical devices.
-    The Ministry of Industry and Trade (MOIT) is responsible for issuing regulations on the import/export of goods.
 
Medical Device Management Regulations:
On May 15, 2016, the Government of Vietnam issued Decree 36/2016/ND-CP, regulating the management of medical equipment which included the classification of medical equipment; production, labeling, circulation, procurement, supply, online declaration, registration, management, and use of medical equipment. Decree 36 governs the management of medical equipment and requires all medical devices imported into Vietnam to register for marketing authorization (MA) licenses. 

On December 31, 2018, the Government of Vietnam issued Decree 169/2018/ND-CP, providing amendments and additions to this Decree. Major updates included the classification of medical devices, production, registration, management of trading of medical devices, medical device services, information and labeling, management, and the use of medical devices at medical facilities, online declaration and registration, organization, and implementation.
On January 1, 2020, the Government of Vietnam issued Decree 03/2020/ND-CP, amending and supplementing Article 68 - Transitional Clause of the Decree 169/2018/ND-CP. Accordingly, import licenses for medical devices Type B, C, and D were extended to December 31, 2021.

Application Procedure:
Medical devices are classified as Type A, B, C, or D. Accordingly, there are mainly two processes for Type A and Type B, C, and D.
- Type A: consists of medical devices with a low-risk level related to the technical design and manufacture of the medical devices:

  • Companies responsible for introducing the medical devices to the market are obliged to send declarations of applicable standards to Health Departments (DOH) where the companies are based via the online portal of DMEC at https://dmec.moh.gov.vn/ 
  • Upon receiving satisfactory documents, Health Departments shall issue notice of receipt of declarations for applicable standards.
  • The registration number for Type A medical devices is effective indefinitely.

- Type B, C, and D medical devices include medical devices with low to medium, medium to high, and high-risk levels.

  • Registration applications must be submitted to the DMEC via the online portal of DMEC at https://dmec.moh.gov.vn/ 
  • After receiving an application, notice of receipt of the application shall be sent to the applicant.
  • In case no revision is required:
    - For medical devices that already have respective national technical regulations, a registration number shall be extended 10 to 30 days from the date specified on the receipt notice depending.
    - For medical devices that do not have respective national technical regulations, a new registration number shall be issued 15 to 60 days from the date specified on the receipt notice.
  • In case of incomplete applications, the MOH must inform the applicants in writing to revise the applications by specifying documents and contents that must be revised.
  • If applicants fail to adequately revise applications after 90 days from the date the MOH issues requesting documents or if the applicants fail to adequately revise the applications five consecutive times, the applicants must restart the process.
  • Registration numbers for Type B, C, or D are effective for 5 years from the date of issue.

For further information on the medical device market in Vietnam, please contact Commercial Specialists Nhung.Nguyen@trade.gov and Thao.Nguyen@trade.gov.
 

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