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Medical Device Grouping in Vietnam
Grouping requirements in Vietnam are guided by Appendix II of Circular 39/2016 released in October 2016. Grouping allows for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer. To be grouped together, the products will need to adhere to the specific rules to belong to certain categories.
The different grouping categories are as follows:
- IVD Test Kit
- IVD Cluster
Three general principles generally apply to each category:
- One generic proprietary name
- One product owner
- One common intended purpose
General Decision Flowchart for 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.
- Condoms that are sold in packages of 3, 12 and 144 can be grouped as a single medical device when submitting for registration.
- 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:
- is from the same product owner;
- is of the same risk classification;
- has a common intended purpose;
- has a common design and manufacturing process; and
- 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;
- intended to be used in combination to achieve a common intended purpose;
- compatible when used as a system; and
- sold under a single system name or the labelling, instructions for use, brochures or catalogues for each
- constituent component indicates that the constituent component is intended to be used together or for use with the system.
- the systems are from the same product owner;
- the systems are of the same risk classification;
- the systems have a common intended purpose;
- the systems have a common design and manufacturing process; and
- 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:
- from the same product owner;
- intended to be used in combination to complete a specific intended purpose;
- 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
- compatible when used as a test kit.
An IVD Cluster comprises of a number of in vitro diagnostic reagents or articles that are:
- from the same product owner;
- is of the same risk classification (either Class A only or Class B only);
- of the same IVD cluster category and a common test methodology as listed in Table 2; and
- 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.
Vietnam Regulatory Support
David’s Regulatory Hint
“Grouping guidance is closely aligned with GHTF guidance but one main difference is that accessories sold separately will either need to be registered separately or not registered at all.”
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Frequently Asked Questions
Who can submit submit applications in Vietnam?
A local entity must submit applications, hold the license, and correspond with the Ministry of Health. License Holders can then authorize an unlimited number of importers or distributors.
How are products classified in Vietnam?
Medical devices are classified into 4 categories according to GHTF guidelines; from low-risk Class A to high-risk Class D.
How long does it take to register my medical device in Vietnam?
Class A and B are immediately listed and Class C and D applications require 30 to 60 days.
How much does it cost to register my device in Vietnam?
Class A fees are about US$45 and Class D are about US$220.
How long are medical device licenses valid in Vietnam?
Medical device licenses do not expire in Vietnam.
Does the license holder need to be a part of the importing process?
No, license holders can authorize multiple importers to import under one license.
Is there an expedited review pathway?
Yes, Class C and D products approved by a reference country will be reviewed in half the time. Reference Countries in Vietnam include: USA, Canada, Europe (incl. UK and Switzerland), Australia, Japan, China, and South Korea.
Is ISO 13485 required for medical devices in Vietnam?
Yes, ISO 13485 is required for registration in Vietnam.
Is Home Country approval required?
No, there are no requirements for home country approval. Reference country approval will significantly improve the review time.
Do documents need to be translated to Vietnamese as part of the application process?
Yes, some application documents will need to be translated including the Instructions for Use (IFU) and the labeling.
Benefits of Independent License Holding through Asia Actual
- Sell directly to multiple regional distributors, avoiding mark-up by a national importer
- Increase transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
- Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the Vietnamese market. Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in Vietnam. Please let us know if we can help with medical device grouping in Vietnam.