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Medical Device Classification in Vietnam
Medical devices are classified in Vietnam according to the intended use, level of risk, delivery method, and the degree of invasiveness in the human body. Vietnam closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices, ranging from low to high risk. Classification guidance can be found in Circular 39/2016.
Previously, medical device risk classification in Vietnam had to be determined by a locally certified organization or person but under the new regulations, the Registration Holder can classify the product as part of the application.
Devices are classified into one of the following, from lowest to highest risk:
- Class A
- Class B
- Class C
- Class D
IVD CLASSIFICATION RULES
IVDs in Vietnam are classified into 4 categories (A through D) according to 7 rules based on risk and closely follow ASEAN MDD guidance. Specific rules for classifying IVDs can be found in Part III of Appendix I, Circular 39/2016.
Factors affecting the risk include:
- Purpose of use and indications
- Expertise of the medical device user
- Importance and Impact of the Medical Device Information on Individuals and Public Health.
Vietnam Regulatory Support
David’s Regulatory Hint
“While previously, a 3rd party was needed to classify medical devices in Vietnam, under the new rules, Asia Actual is qualified to classify medical devices.”
US: +1 512 898-9222
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What is R.O.S.E.?
R.O.S.E. is Asia Actual’s new tool for empowering RA professionals by allowing users to search multiple countries all at once in English. Users can search by product name, manufacturer, brand, product categories and more. Not only does R.O.S.E. help RA professionals find predicates, it can also help classify products and monitor competitors. Then once your products are registered, you can keep track of your registrations and get reminded when they’re due for renewal.
As of April 2022, R.O.S.E. provided members with access to registrations in:
- China – Imported Products
- Hong Kong
- China – Domestic Products (coming soon)
- Taiwan (coming soon)
- India (coming soon)
- USA (coming soon)
How to Classify Your Device in Vietnam
One of the best ways to classify a product is to identify identify competing products, especially those that are at larger companies or have been around a while. This will increase the likelihood of these products being registered internationally and in more markets. Then, once the manufacturer has a list of competitors, or potential “predicate devices,” they will need to confirm that these products are registered in Vietnam. To do so, the manufacturers can work with a local partner to conduct this research, search the Vietnamese database, or use Asia Actual’s Registration Optimized Search Engine (R.O.S.E.) which aggregates registered products from public databases throughout Asia, including Vietnam.
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.