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.
July 16, 2025
Approximately 5 minutes
Vietnam Medical Device Grouping: Simplifying MA Licenses under Circular 39/2016 Guidelines
Vietnam Medical Device Grouping: Simplifying MA Licenses under Circular 39/2016 Guidelines
Medical device grouping in Vietnam is a crucial regulatory strategy that allows manufacturers to submit a single Market Authorization (MA) License application to cover multiple variations or components of a product. This process, primarily guided by Appendix II of Circular 39/2016, simplifies the application process, reducing both time and cost.
General Grouping Principles
For products to be eligible for grouping under a single MA License, they must generally adhere to three core principles:
- One generic proprietary name
- One product owner
- One common intended purpose
Grouping Categories
Vietnam defines several distinct grouping categories, each with specific rules regarding permissible variations:
1. Single Medical Device
This category applies to a device that is sold as a distinct entity and cannot be assigned to any other grouping.
- Example: Condoms sold in different package counts (e.g., 3, 12, 144) can be grouped as a single medical device. Standalone software used with various CT scanners can also be a single grouped device.
2. Medical Device Family
A collection of devices that share the following:
- Same product owner.
- Same risk classification.
- Common intended purpose.
- Common design and manufacturing process.
- Variations are within the scope of permissible variants (e.g., size, color, minor non-critical material changes).
3. Medical Device System
A grouping of multiple components (devices and/or accessories) intended for combined use to achieve a common purpose.
- Requirements: Components must be from the same product owner, compatible, and sold under a single system name, with labeling indicating they are intended for use together.
4. IVD Test Kit
An In Vitro Diagnostic (IVD) device consisting of multiple reagents or articles that are:
- From the same product owner.
- Intended to be used in combination to complete a specific intended purpose.
- Sold under a single TEST KIT name.
5. IVD Cluster
A grouping of multiple IVD reagents or articles that:
- Are from the same product owner.
- Are of the same risk classification (Class A only or Class B only).
- Belong to the same IVD cluster category and common test methodology.
Key Difference from Global Guidance
While Vietnamese grouping guidance is closely aligned with GHTF principles, manufacturers should note that there are subtle but important differences, such as the registration of accessories:
Regulatory Hint: Unlike some jurisdictions, accessories sold separately will either need to be registered as their own Single Medical Device or not registered at all. They generally cannot be absorbed into the main device registration if they are marketed independently.
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 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.