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.
June 16, 2025
Approximately 5 minutes
Vietnam Medical Device Classification: GHTF Risk Levels and Registration Holder Responsibility
Vietnam Medical Device Classification: GHTF Risk Levels and Registration Holder Responsibility
The classification of a medical device is the foundational first step for regulatory compliance in Vietnam, determining the subsequent regulatory pathway (Notification vs. MA License) and the required documentation. Vietnam’s classification system aligns closely with the international Global Harmonization Task Force (GHTF) guidelines.
The Four Risk Classes
Medical devices in Vietnam are categorized into four classes, ranging from the lowest to the highest risk, based on factors such as intended use, level of risk to the patient, delivery method, and degree of invasiveness.
- Class A: Low Risk
- Class B: Medium-Low Risk
- Class C: Medium-High Risk
- Class D: High Risk
Classification guidance is primarily found in Circular 05/2022 (which replaced Circular 39/2016).
Responsibility Shift to the Registration Holder
Under previous Vietnamese regulations, device risk classification had to be performed by a locally certified third-party organization or person. Decree 98/2021/ND-CP implemented a significant change to streamline this process:
- New Rule: The responsibility for classifying the product now falls directly to the Registration Holder (the local authorized representative) as part of the overall application submission process.
- Impact: This shift allows manufacturers and their local agents greater control over the initial classification, though it must still strictly adhere to the guidelines set out in the relevant Circulars.
IVD Classification
In Vitro Diagnostic (IVD) devices are also classified into the same four categories (A through D). The classification rules for IVDs are based on 7 specific rules outlined in the regulatory appendices and closely follow the guidance provided by the ASEAN Medical Device Directive (MDD).
Factors that specifically affect the risk classification of IVDs include:
- Purpose of use and intended indications.
- Expertise of the medical device user.
- Importance and impact of the device information on individuals and public health.
Accurate classification is mandatory for market entry, as it dictates the level of regulatory scrutiny and the specific documentation required for obtaining the Market Authorization (MA) License.
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 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 Advertising: Mandatory Public Portal Submission and Content Requirements
Under **Decree 98/2021 (Article 62)**, all medical device advertising materials (print, internet, video), including those for healthcare professionals and the public, must be **uploaded to the MoH public portal** before market placement. After uploading, a unique number is generated, which must be displayed on the advertising material. Failure to comply or meet MoH requirements can lead to removal from the market.
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.