Vietnam Medical Device Registration
In 2019, the Vietnam Medical Device (MD) market was valued at $1.5 billion USD, positioning Vietnam as the ninth-largest market in the Asia-Pacific region. Over 90 percent of medical equipment and supplies are imported into the country. According to Fitch Solutions, the sector is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.5 percent over the period of 2022 to 2027. The most imported and used medical equipment include consumables, diagnostic imaging, dental products, orthopedics and prosthetics, and patient aids.
On November 8, 2021, the Government of Vietnam (GVN) issued Decree No. 98/2021/ND-CP on the management of medical devices (“Decree 98”), which took effect from January 1, 2022 and replaced Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP, and Decree No. 03/2020/ND-CP.
Under Decree 98, the local Department of Health is responsible for the notification of Class A and B medical devices, while Class C and D medical devices are subject to product registration with the Ministry of Health. The medical device registration numbers shall remain valid indefinitely.
On March 3, 2023, Vietnam issued Decree 07/2023/ND-CP (Decree 07), amending and supplementing Decree No. 98/2021/ND-CP. Decree 07 allows all existing import licenses to be automatically extended to December 31, 2024.
- The Ministry of Health of Vietnam (MOH) is responsible for state management of medical devices, implementation of legislative documents, national technical regulations, strategies, policies, and plans on medical devices, conducting inspections, settling complaints/denunciations, and taking actions against violations related to medical devices in accordance with regulations of Decree 07 and relevant laws.
- The Infrastructure and Medical Device Administration (IMDA) is a specialized department under the MOH that advises and assists the Minister in state management and organizes law enforcement on the construction of medical works and medical equipment.
- The Administration oversees issuing detailed regulations on standards, import licenses, registration numbers for medical devices (Class C and D), Certificates of Free Sales, medical device price declaration, and confirming advertising content.
- The Ministry of Science and Technology (MOST) is responsible for formulating national standards for medical devices, quality inspection of medical devices, measuring devices, and radiation equipment.
- The Ministry of Finance (MOF) provides guidelines for the management of public assets and specific provisions on the management and use of fees in the field of medical devices.
- The Ministry of Industry and Trade (MOIT) is responsible for issuing regulations on the import/export of goods.
- Provincial People’s Committees is responsible for activities relating to trading and use of medical devices in the province, publishing on the Portal of the provincial People’s Committee and sending to the MOH the information of a) successful bids for medical devices of State-owned health facilities in the province, b) List of medical devices whose registration number has been revoked in the province, and taking responsibility to organize and process procedures as prescribed in Decree 07; organize inspections, settle complaints/denunciations and take actions against violations related to medical devices and their prices in their provinces following regulations of law.
Medical devices are classified as Type A, B, C, or D. Accordingly, there are mainly two processes for Type A & B and Type C & D.
Type A and B consist of medical devices with low-risk and low-moderate risk levels related to the technical design and manufacture of the medical devices:
- The organization responsible for placing medical devices of type A and B on the market is obliged to submit applications for declaration to the Department of Health (DOH), where they are located via the online portal of IMDA at https://dmec.moh.gov.vn/
- Upon receiving satisfactory documents, the Department of Health shall publish the number of declarations of applied standards for Class-A or Class-B medical devices on the portal on the management of medical devices and applications for declaration of applied standards.
- The local authorities apply a post-market audit mechanism.
Type C and D medical devices include medical devices with moderate-high risk and high-risk levels.
- Registration applications must be submitted to the IMDA via the online portal of IMDA at https://dmec.moh.gov.vn/
- After receiving an application, a notice of receipt shall be sent to the applicant.
- If the application is satisfactory, the MOH shall process it within 30 days of receiving the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance of Vietnam). A written response indicating reasons for such refusal shall be provided if an application is refused.
- If the application is not satisfactory, the MOH shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 25 days of receipt of the application.
- The applicant shall comply with the request for modification and send modified documents to the MOH as requested.
- If the modified application is still unsatisfactory, the MOH shall continue sending a request for modification to the applicant as prescribed in Point B Clause 2 of Article 32 of Decree 07.
- If the applicant fails to provide the modified application within 90 days from the receipt of the MOH’s request for modification or the application is still unsatisfactory after five modification times, the application shall be rejected.
- Post-market inspection is applied to control the quality of medical devices imported and circulated in Vietnam.
For more information, please contact:
Ms. Nhung Nguyen, Commercial Specialist
U.S. Commercial Service Hanoi, U.S. Embassy in Hanoi
Mr. Thao Nguyen, Commercial Specialist
U.S. Commercial Service Ho Chi Minh City, U.S. Consulate General in HCMC