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.
May 16, 2025
Approximately 5 minutes
Vietnam IVD Device Registration: Decree 98 and the Transition to Medical Device Status
Vietnam IVD Device Registration: Decree 98 and the Transition to Medical Device Status
In Vietnam, the regulation of In Vitro Diagnostic (IVD) devices is undergoing a significant transition under Decree No. 98/2021/ND-CP. Previously, standalone reagents were regulated as pharmaceuticals; however, the new framework unifies all IVD products under the medical device regulations, overseen by the Ministry of Health (MoH).
Classification and Grouping
Vietnam follows the GHTF guidelines for risk-based classification (Class A to D).
- Risk Classification: IVD components are classified based on the intended end-use risk of the entire system. For example, IVD components used together as a system can be classified according to the highest risk level of the combined system.
- Grouping: Vietnamese regulations feature unique product grouping rules. Manufacturers often need more applications than in other markets to cover all models, particularly due to complexity in grouping by number of models, portability, and risk class.
Regulatory Pathway: Market Authorization (MA) License
All classes of IVD devices are now required to obtain a Market Authorization (MA) License.
- Validity: MA Licenses do not expire under the new Decree, providing indefinite market access once granted.
- Local Agent: A foreign manufacturer must appoint a local, registered company in Vietnam to act as the Registration Holder to submit the application and maintain the license.
| Class | Review Time (Target) | Pathway |
|---|---|---|
| Class A/B | Immediate (Approx. 5 days) | Quick administrative review and Notification process by the provincial Health Department. |
| Class C/D | Target: 10–90 days (Actual: Highly delayed) | Full Technical Review by the central MoH. |
Expedited Review for Class C and D
The MoH encourages manufacturers of Class C and D IVDs to utilize the Reference Country Approval pathway to expedite the review process:
- Reference Countries: Approval from the USA, Canada, EU, Japan, Australia, China, or Korea can be used to waive the Technical Review requirement.
- Timeline Benefit: This is intended to shorten the review time from up to 90 days (Technical Review) to approximately 10 working days.
Documentation and Compliance
- Documentation Format: Applications are transitioning from requiring standard administrative documents and a technical summary to the Common Submission Dossier Template (CSDT) format.
- Language: Documentation may be submitted in Vietnamese or English during the transition period, but the Instructions for Use (IFU) and Technical Summary must be in Vietnamese.
- Quality System: An ISO 13485 certificate is required for Class B, C, and D devices to demonstrate Quality Systems Conformity.
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 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 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.