Medical Device Grouping in Vietnam

Grouping Definitions and Examples

Below are excerpts from Circular 39/2016 outlining the permissible grouping variations and relevant definitions. More information on grouping requirements in Vietnam, including decision flow charts, please see the Circular.

A single medical device is a medical device from a product owner identified by a proprietary name or brand name with a specific intended purpose and sold as a distinct packaged entity and that cannot be assigned into a family, IVD test kit, system, IVD cluster or group.
Examples:

1. Condoms that are sold in packages of 3, 12 and 144 can be grouped as a single medical device when submitting for registration.
2. A company manufactures a standalone software program that can be used with a number of CT scanners produced by other product owners. The standalone software program itself is deemed a medical device, which can be used on different scanners. The software can be grouped as a single medical device.

A medical device Family is a collection of medical devices and each medical device family member:

1. is from the same product owner;
2. is of the same risk classification;
3. has a common intended purpose;
4. has a common design and manufacturing process; and
5. has variations that are within the scope of the permissible variants.

Examples of permissible Family variants can be found in Appendix II of Circular 39/2016.

A medical device System comprises of a number of medical devices and/or accessories that are:
from the same product owner;

1. intended to be used in combination to achieve a common intended purpose;
2. compatible when used as a system; and
3. sold under a single system name or the labelling, instructions for use, brochures or catalogues for each
4. constituent component indicates that the constituent component is intended to be used together or for use with the system.
5. the systems are from the same product owner;
6. the systems are of the same risk classification;
7. the systems have a common intended purpose;
8. the systems have a common design and manufacturing process; and
9. key constituent components of the systems have variations that are within the scope of the permissible variants.

An IVD Test Kit is an in vitro diagnostic (IVD) device that consists of reagents or articles that are:

1. from the same product owner;
2. intended to be used in combination to complete a specific intended purpose;
3. sold under a single TEST KIT name or the labeling, instructions for use, brochures or catalogues for each reagents or article states that the component is intended for use with the IVD test kit; and
4. compatible when used as a test kit.

An IVD Cluster comprises of a number of in vitro diagnostic reagents or articles that are:

1. from the same product owner;
2. is of the same risk classification (either Class A only or Class B only);
3. of the same IVD cluster category and a common test methodology as listed in Table 2; and
   1. The IVD cluster may include analyzers that are designed for use with the reagents in the IVD cluster.

A list of common test methodologies and IVD cluster categories can be found in Table 2 of Appendix II of Circular 39/2016.