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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.
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