Register medical devices in Thailand
How Andaman Medical can help you register your medical device in Thailand
Andaman Medical is a fully licensed Local Authorized Representative for medical devices in Thailand. We have been representing medical device manufacturers and distributors in Thailand 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 Thailand, we will:
- represent your company in all dealings with the Thai FDA and other authorities responsible for medical devices and in-vitro diagnostics
- register your product
- ensure that the medical device or IVD is correctly labelled, and that information is provided in the Thai for home use medical devices
- import your product
- submit change notifications
- ensure post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Effects (commonly known as Adverse Events) and Field Safety Corrective Actions
If you are still uncertain about whether your medical device will comply with the regulatory complexities in Thailand, you can request an Intelligence Report for your product
You can also check out our latest Insights on the Thai market and find out more about the Thai medical device market.
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We look forward to hearing from you!