Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
October 16, 2025
Approximately 5 minutes
Vietnam Medical Device Advertising: Mandatory Public Portal Submission and Content Requirements
Vietnam Medical Device Advertising: Mandatory Public Portal Submission and Content Requirements
Medical device advertising in Vietnam is strictly regulated by the Ministry of Health (MoH) under the provisions of Decree 98/2021/ND-CP, with requirements implemented since July 2022. The key regulatory mechanism is the mandatory submission of all promotional materials to a public portal.
Mandatory Public Portal Submission
Per Article 62 of Decree 98/2021, a broad range of promotional content must be uploaded to the MoH public portal before the advertisement is placed on the market.
- Scope: This requirement applies to ALL advertising material, regardless of the medium (print, internet, video, etc.) and regardless of the target audience (Direct-to-Consumer (DTC) or healthcare professionals).
- Compliance Process: Once the material is successfully uploaded to the public portal (a process for which there is currently no fee), a unique circulation number is provided. This number must then be prominently included in the advertising material.
- Enforcement: Advertisements that fail to meet the MoH's requirements or do not display the circulation number may be removed from the market.
Mandatory Advertising Content
All approved advertising materials must contain specific, verified information to ensure transparency and accountability. This includes:
- Product Identification: Name of medical equipment, type, product code, manufacturer, and manufacturing country.
- Circulation Number: The unique number provided by the MoH public portal upon submission.
- Features and Effects: Clear statement of the device's features and effects (therapeutic claims).
- License Holder Information: Name and address of the License Holder (of the free-sale registration number) or the organization authorized by the License Holder.
- Warnings: Warnings related to the user's health and storage conditions (if any).
Exemptions from Public Portal Submission
Certain types of materials are exempt from the mandatory upload requirement, as they are not considered direct advertisements or are intended purely for technical or internal use:
- Materials that do not refer to the medical device name.
- Materials that only list names and technical specifications of medical equipment but contain no information on features and effects.
- Scientific research papers and clinical documentation.
- Training materials supporting product manuals (Instructions for Use).
Compliance with these submission and content requirements is essential for ensuring the legality of any promotional activities in the Vietnamese medical device market.
Related Articles
Approximately 5 minutes
Vietnam Medical Device Registration: Decree 98, MA License, and Transitioning Market
Vietnam’s medical device regulation, overseen by the **IMDA** under the MoH, is transitioning under **Decree No. 98/2021**. All devices require a **Market Authorization (MA) License**, which does not expire. Foreign manufacturers must appoint a local **Registration Holder**. Class A and B devices are immediately listed through a notification process, while Class C and D devices face significant delays but can utilize **Reference Country approval** (US, EU, Australia, etc.) for an expedited review.
Approximately 5 minutes
Vietnam IVD Device Registration: Decree 98 and the Transition to Medical Device Status
Vietnam’s In Vitro Diagnostic (IVD) regulation is under a major transition, consolidating all IVD products under the medical device framework (Decree 98/2021). IVD components are now classified (A to D) based on risk. All classes require a **Market Authorization (MA) License**, which does not expire. Class A/B receive immediate administrative approval, while Class C/D utilize the **Reference Country approval** pathway to expedite the lengthy technical review process.
Approximately 5 minutes
Vietnam Medical Device Classification: GHTF Risk Levels and Registration Holder Responsibility
Medical device classification in Vietnam follows the **GHTF guidelines** and is based on the intended use, risk, and invasiveness, categorizing devices from lowest to highest risk as **Class A, B, C, and D**. Under the new regulations (Decree 98/2021), the responsibility for classifying the product has shifted from a certified third party to the **Registration Holder** as part of the market authorization application.
Approximately 5 minutes
Vietnam Medical Device Grouping: Simplifying MA Licenses under Circular 39/2016 Guidelines
Vietnam allows for the grouping of multiple medical device variations under a single **Market Authorization (MA) License** application, guided by **Circular 39/2016 (Appendix II)**. The primary grouping categories are **Single Family, System, IVD Test Kit, and IVD Cluster**. All grouped devices must share the same product owner, intended purpose, and typically a common proprietary name, streamlining the registration process and saving costs for manufacturers.
Approximately 5 minutes
Vietnam Local Labeling Requirements: Mandatory Vietnamese and Secondary Labeling After Customs
Medical device labeling in Vietnam is governed by **Decree 43/2017** and **Decree 111/2021**. While imported products can have international labels for customs clearance, all devices must be labeled in **Vietnamese** before reaching the end user. This usually requires a **secondary label** to be affixed after importation, including mandatory details such as the product name, License Holder's name and address, and the circulation/MA license number.
Approximately 5 minutes
Vietnam Medical Device License Maintenance: Mandatory Amendments for Post-Approval Changes
Unlike many other markets, Vietnam often requires a formal **amendment** to the Market Authorization (MA) License **before** a modified medical device can be imported or marketed. Changes, even minor ones, such as updating the License Holder's or manufacturer's name/address (but not both), packaging, or IFU/labeling, necessitate a notification to the Ministry of Health (MoH). Failure to comply can lead to customs clearance delays or loss of market access.
Approximately 5 minutes
Vietnam Medical Device Importing and Customs Clearance: Roles and Common Delays
The Vietnamese customs clearance process requires a separation between the **Market Authorization (MA) License Holder** and the **Importer**. The License Holder must provide an authorization letter and the MA License to the licensed Importer to clear the shipment. Common causes of customs delays include inconsistent **HS Codes** across shipments, discrepancies between declared value and shipment value, and inconsistencies between the registered product label and the actual physical label.