Market Information
Vietnam’s healthcare expenditure was approximately $17 billion in 2018 (6.6% of GDP) and will grow to $23 billion in 2022 (11% CAGR).
Market Trend: More than 85 million people, nearly 90% of the population, were covered by health insurance last year.
Vietnam’s medical equipment market is currently valued at nearly US$1.3 billion with an annual growth rate of 12% - 15%, and more than 90% of medical equipment in Vietnam is imported. Of these, more than half come from the United States, Japan, Singapore, Germany and China.
The remaining 10% market share of medical equipment comes from roughly 300 local firms that primarily manufacture simple and low value-added products, such as beds, trolleys and hospital furniture.
Medical Device Regulation
Department of Medical Equipment and Construction (DMEC), under the MOH.
•Decree 98/2021/ND-CP: On 8 Nov 2021, effective 1 Jan 2022. Replace 36/2016, 169/2018, 03/2020.
•Decree 111/2021: Amends 43/2017 and Updates Labeling requirements
•Circular 05/2022: Product Control list require Import License or Marketing Authorization License. Not in this list with transition until 31 Dec 2024.
•Decree 07/2023: Existing Import license extended to 31 Dec 2024 and CSDT submission effective 1 Jan 2024.
Classification, Fees, Timeline
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Product Registration Routes
Class A, B (Online submission to local province DOH)
Market Authorization (MA) License application (instead of Import License)
Class C, D (Online submission to DMEC)
Market Authorization (MA) License application
•Normal track without Reference agencies approval
•Fast track with Reference agencies approval
AU, CHINA, CND, EU, JP, KR, SWISS, UK, US
•Emergency purpose for epidemic prevention, control and overcoming consequences of natural disasters and catastrophes by MOH AND meet one criteria where Products approved for such in the reference countries, WHO list, EU Health Security Committee.
Useful Information
Validity of License: Indefinite (Previously Import License valid 5 years)
License transfer: Not available at present. Reregistration is required.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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