Register medical devices in Vietnam
How Andaman Medical can help you register your medical device in Vietnam
Andaman Medical is a fully licensed Local Authorized Representative for medical devices in Vietnam. We have been representing medical device manufacturers and distributors in Vietnam since 2017 including startups to medium-sized and multinational enterprises, covering all product risk classes and sectors of the medical device industry.
As your in-country representative for Vietnam, we will:
- represent your company in all dealings with the Vietnamese Ministry of Health and other authorities responsible for medical devices and in-vitro diagnostics
- register your product
- ensure that the medical device or IVD is correctly labelled
- import your product
- submit change notifications
- ensure post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events and Field Safety Corrective Actions.
If you are still uncertain about whether your medical device will comply with the regulatory complexities in Vietnam, you can request an Intelligence Report for your product.
You can also check out our latest Insights on the Vietnamese market and find out more about Vietnam’s medical device market.
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We look forward to hearing from you!