Medical devices and IVDs sold in Vietnam must be registered with the IMDA, Vietnam's medical device regulatory. The Vietnam device registration process involves notification of Class A devices or submitting a technical dossier for Class B, C, and D devices. All foreign manufacturers needs an in-country representative.
Pure Global simplifies the process with AI workflows that accelerate submission preparation, along with local support and representation, all for a flat annual fee.
Vietnam’s medical devices market will reach $2.47B by 2029 (8.62% CAGR), and the IVD market$1.90B (4.65% CAGR). Growth is driven by rising healthcare spending (6.6% of GDP), an aging population (7.9% 65+ in 2021), and heavy reliance on imports (90%).
Medical devices sold in Vietnam are regulated by the the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MOH) (renamed from Department of Medical Equipment and Construction (DMEC) in January 2025). Pure Global can assist with Vietnam's medical device registration and act as your Marketing Authorization Holder (MAH), ensuring MOH approval to sell in the Vietnamese market.
Vietnam categorizes medical devices into four classes (A to D) based on risk, with Class A representing the lowest risk. Understanding this classification is crucial for determining the regulatory pathway and requirements for market entry.
To market in Vietnam, foreign manufacturers must:
We provide turnkey regulatory support in Vietnam, all for a flat annual fee:
Dossier preparation and submission, powered by AI-assisted workflows and regulatory experts.
In-country representation, with Pure Global serving as your Marketing Authorization Holder (MAH).
Post-market surveillance support, including vigilance reporting and authority communications.
Importer authorizations, post-approval modifications, and renewals.
Vietnam charges mandatory government fees for medical device registration based on device risk class, with fees assessed per product.
Application fees are as follows:
All fees listed are government fees only and do not include consulting services, dossier preparation, translations, local registration holder services, or regulatory representation. Fees may change without notice.
Check our Fee Calculator for up-to-date government fees in 14 markets.
Pure Global offers flat-fee annual pricing for bundled medical device and IVD registration and representation in Vietnam, starting at $2,000/year. The flat fee includes dossier preparation and submission, in-country representation, translation, modifications, distributor authorization, and post-market support. The fee does not include government fees, certified translations, or translations from languages other than English.
Flat fee structure for medical devices and IVDs:
1 device = $2,000/year
2-10 devices = additional $500 per device per year (e.g., 7 devices = $5,000/year)
Contact us for a custom quote if you have 11+ devices.
A three-year contract is required to lock in the fees quoted above. However, other contractual arrangements are available. Use our Fee Calculator for an instant estimate and more information about flat fee terms.
Medical devices in Vietnam are categorized into four classes (A to D) based on their risk level, with Class A representing the lowest risk and Class D the highest. This Vietnam medical device classification determines the regulatory pathway and specific requirements for market entry. They oversee the compliance and regulatory requirements for market entry.
Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) to represent them in regulatory submissions and interactions with Vietnamese authorities. According to Vietnam medical device regulations, they also need to compile a comprehensive technical dossier for submission to the Department of Medical Equipment and Construction (DMEC) for Class B, C, and D devices, or notify the Provincial Department of Health for Class A devices as part of the Vietnam medical device registration process.
The Marketing Authorization Holder (MAH) acts as the representative for foreign manufacturers in regulatory submissions and interactions with the Vietnamese authorities. The MAH ensures that the necessary documentation and compliance requirements are met for Vietnam medical device registration and market entry of medical devices in Vietnam.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us
%201.svg)
